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Diabetes is a disease caused by high levels of blood glucose resulting from improper production of insulin or action of insulin.
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* '''Type 1''': In this Diabetes, the cells that make the hormone insulin regulate the blood glucose are destroyed by the body immune system. This is also called as juvenile onset diabetes as it occurs mainly in children and young adults. 5%-10% of all the cases of diabetes have Type I diabetes. Clinical trials are being pursued and planned to prevent type I diabetes. This is also called as Insulin Dependent Diabetes Mellitus (IDDM).  
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* '''Type 2''': In this case, either the cells do not use insulin properly or the body does not produce enough insulin. 90% - 95% of the diabetics have Type 2 diabetes. This type of disease is also called as non-insulin dependent diabetes mellitus (NIDDM) and is mainly observed in people with old age, obese, family history of diabetes, history of gestational diabetes, impaired glucose metabolism, physical inactivity and race/ethnicity.  
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* '''Gestational Diabetes''': Increase in the levels of blood sugar during pregnancy is called gestational diabetes.
  
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==Incidence and prevalence==
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===Incidence===
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In year 2004, diabetes ( Both type I and type II ) was diagnosed in 1.4 million adults between the age of 18-79 years (Figure 1). The incidence of diabetes was lower in adults having an age between 18-44 years compared to other groups (Figure 2). From 1997 through 2004, the age adjusted incidence of diagnosed diabetes ( Both type I and type II )increased by 35% among men and 46% among women (Figure 3).
  
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[[Image:Number in thousands vs Year.jpg|left|250 px|thumb|Figure 1. Annual number (in thousands) of new cases of diagnosed diabetes among adults aged 18-79 years, in United States from 1997-2004. [http://www.cdc.gov/diabetes/statistics/incidence/fig1.htm Source]]]
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Figure 3. Gender based incidence of diagnosed diabetes per 1000 population aged from 18-79 years in U.S. [http://www.cdc.gov/diabetes/statistics/incidence/fig4.htm Source]]]
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[[Image: Rate per 1000 vs Year.jpg|center|250 px|thumb|Figure 2. Incidence of diagnosed diabetes per 1000 population aged 18-79 years, by age in U.S from 1997 to 2004. [http://www.cdc.gov/diabetes/statistics/incidence/fig3.htm Source]]].
  
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*The following table attempts to extrapolate the incidence rate for Diabetes( both type I and type II ) to the populations of various countries and regions.[http://cureresearch.com/d/diabetes/stats-country.htm Cure reasearch, Statistics by Country for Diabetes]
 +
{|border="2" cellspacing="0" cellpadding="4" width="86%"
 +
|align = "center" bgcolor = "#FFFF00"|'''  S.NO'''
 +
|bgcolor = "#FFFF00"|'''Country/Region'''
 +
|bgcolor = "#FFFF00"|'''Extrapolated incidence'''
 +
|-
 +
|align = "center"|1
 +
| USA
 +
|861,533
 +
|-
 +
|align = "center"|2
 +
|Canada
 +
|95,372
 +
|-
 +
|align = "center"|3
 +
|Europe
 +
|1,474,002
 +
|-
 +
|align = "center"|4
 +
|Asia
 +
|10,063,645
 +
|-
 +
|align = "center"|5
 +
|Africa
 +
|1,290,255
 +
|-
 +
|align = "center"|6
 +
|Middle east
 +
|1,055,809
 +
|-
 +
|align = "center"|7
 +
|Australia and Southern Pacific
 +
|70,138
 +
|-
 +
|}
  
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===Prevalence===
 +
The prevalence of diabetes( Both type I and type II ) in U.S. during the years 1980 to 2005, increased from 5.6 million to 15.8 million (Figure 4). Especially people aged from 65 to 74 had the highest prevalence compared to other age groups (Figure 5). The prevalence of the disease was similar in both men and women till the year 1998 but from 1999, the prevalence of the disease increased highly in men compared to females (Figure 6).
  
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[[Image:Number vs Year.jpg|left|250 px|thumb|Figure 4. Number (millions) of persons with diagnosed diabetes from year 1980 to 2005 in United States. [http://www.cdc.gov/diabetes/statistics/prev/national/figpersons.htm Source]]]
  
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[[Image:Rate_per_100_vs_Age.jpg|right|250 px|thumb|Figure 5. Age dependent Prevalence of diagnosed diabetes in United States from year 1980 to 2005. [http://www.cdc.gov/diabetes/statistics/prev/national/figbyage.htm Source]]]
  
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[[Image:Rate per 100 vs Year.jpg|center|250 px|thumb|Figure 6. Gender dependent Prevalence of diagnosed diabetes in United States from year 1980 to 2005. [http://www.cdc.gov/diabetes/statistics/prev/national/figbysex.htm Source]]].
 +
*The following table attempts to extrapolate the prevalence rate for Diabetes( both type I and type II ) to the populations of various countries and regions.[http://cureresearch.com/d/diabetes/stats-country.htm Cure reasearch, Statistics by Country for Diabetes].
 +
{|border="2" cellspacing="0" cellpadding="4" width="86%"
 +
|align = "center" bgcolor = "#FFFF00"|'''  S.NO'''
 +
|bgcolor = "#FFFF00"|'''Country/Region'''
 +
|bgcolor = "#FFFF00"|'''Extrapolated Prevalence'''
 +
|-
 +
|align = "center"|1
 +
| USA
 +
|17,273,847
 +
|-
 +
|align = "center"|2
 +
|Canada
 +
|1,912,227
 +
|-
 +
|align = "center"|3
 +
|Europe
 +
|33,882,009
 +
|-
 +
|align = "center"|4
 +
|Asia
 +
|201,777,550
 +
|-
 +
|align = "center"|5
 +
|Africa
 +
|25,393,535
 +
|-
 +
|align = "center"|6
 +
|Middle east
 +
|21,169,243
 +
|-
 +
|align = "center"|7
 +
|Australia and Southern Pacific
 +
|1,406,291
 +
|-
 +
|}
  
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==Market Overview==
 +
* The Insulin market in 2006 was largely dominated by two players, Novo Nordisk of Denmark and Eli Lilly of USA.
 +
* India and China are emerging as the most potential future markets for insulin delivery devices.
 +
* Growing at a CAGR of 14.09%, global insulin market will reach US$ 14.5 Billion by 2010 from US$ 7.5 Billion in 2005.
 +
* Over 60% of the insulin sold in 2006 was sold in pen devices.
 +
* Insulin pen devices dominate the market in Europe and Japan whereas syringes and pumps dominate the US market.
 +
* There was a big improvement in the global diabetes market for innovation particularly in the field of non-invasive methods of insulin delivery, including inhalable, oral and patch technology. [http://www.marketresearch.com/product/display.asp?productid=1491639&g=1 Source]
 +
* There are 3 key new OAD classes; PPAR agonists, GLP-1 agonists/DPP IV inhibitors, and amlinomimetic agents. High forecasted sales are anticipated in 2011 for the GLP-1 agonist Exenatide LAR and the DPP-IV inhibitor Galvus at $2,902.9m and $1,228.7m, respectively. [http://www.marketresearch.com/product/display.asp?productid=1286835&g=1 Source]
  
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[[Image:Diabetic market data.jpeg|thumb|center|800 px|]]
 +
 
 +
A. [http://www.globalbusinessinsights.com/content/rbhc0159m.pdf Competitive dynamics of the leading players in the global diabetes market, 2005]
 +
B. [http://www.globalbusinessinsights.com/content/rbhc0159m.pdf  Global diabetes market share by geography, 2005]]
 +
C. [http://www.bccresearch.com/editors/RB-158.html Worldwide Diabetes Market, 2000, 2001, 2002 and 2007]
 +
D. [http://www.globalbusinessinsights.com/content/rbhc0126m.PDF Global* market share of leading insulins (%), 1999-2003]
 +
 
 +
==Product Information==
 +
 
 +
[[Image:diabetes4.jpg|800 px|center|thumb| Overall categorization of diabetes treatments]]
 +
 
 +
===Products: Oral Hypoglycemic Agents===
 +
{|border="2" cellspacing="0" cellpadding="4" width="100%"
 +
|bgcolor = "#FFFF00" colspan = "4"|<font size = "5">Oral Hypoglycemic Agents</font>
 +
|-
 +
|bgcolor = "#CCFFFF"|'''Drug'''
 +
|bgcolor = "#CCFFFF"|'''Brand'''
 +
|bgcolor = "#CCFFFF"|'''Company'''
 +
|bgcolor = "#CCFFFF"|'''Availability'''
 +
|-
 +
|colspan = "4" |<font color="#FF0000"> '''Sulfonylureas'''</font>
 +
|-
 +
|'''First Generation'''
 +
|&nbsp;
 +
|&nbsp;
 +
|&nbsp;
 +
|-
 +
|Acetohexomide
 +
|Dymelor
 +
|Eli Lilly
 +
|US, F, G, I, S,UK, J
 +
|-
 +
|Chlorpropamide, Tolazamide
 +
|Diabenase
 +
|Pfizer
 +
|US, F, G, I, S,UK, J
 +
|-
 +
|'''Second Generation'''
 +
|&nbsp;
 +
|&nbsp;
 +
|&nbsp;
 +
|-
 +
|Glyburide (Glibenclamide)
 +
|Diabeta
 +
|Aventis
 +
|US, F, G, I, S,UK, J
 +
|-
 +
|Glyburide (Glibenclamide)
 +
|Micronase
 +
|Pharmacia
 +
|US, F, G, I, S,UK, J
 +
|-
 +
|Glyburide (Glibenclamide)
 +
|Glynase
 +
|Pharmacia
 +
|US, F, G, I, S,UK, J
 +
|-
 +
|Glypizide
 +
|Glucotrol, Glucotrol XL
 +
|Pfizer
 +
|US, F, G, I, S,UK, J
 +
|-
 +
|'''Third Generation'''
 +
|&nbsp;
 +
|&nbsp;
 +
|&nbsp;
 +
|-
 +
|Glimepride
 +
|Amaryl
 +
|Aventis
 +
|US, F, G, I, S,UK, J
 +
|-
 +
|colspan = "4" |<font color="#FF0000">'''Meglitnides'''</font>
 +
|-
 +
|Repaglinide
 +
|Prandin
 +
|Novo Nordisk
 +
|US, F, G, I, S,UK, J
 +
|-
 +
|Nateglinide
 +
|Sralix
 +
|Novartis
 +
|US,UK, J
 +
|-
 +
|colspan = "4" |<font color="#FF0000">'''Biguanides'''</font>
 +
|-
 +
|Metfromin
 +
|Glucophage, Glucophage XR
 +
|Bristol-Myers Squibb
 +
|US
 +
|-
 +
|Metfromin
 +
|&nbsp;
 +
|&nbsp;
 +
|&nbsp;
 +
|-
 +
|colspan = "4" |<font color="#FF0000">'''Thiazolidinediones'''</font>
 +
|-
 +
|Rosiglitazone
 +
|Avandia
 +
|Glaxosmithkline
 +
|US, G, UK
 +
|-
 +
|Pioglitazone
 +
|Actos
 +
|Takeda/ Eli Lilly
 +
|US, UK, G, S, J
 +
|-
 +
|colspan = "4" |<font color="#FF0000">'''Alfa-Glucosidase Inhibitors'''</font>
 +
|-
 +
|Acarbose
 +
|Precose
 +
|Bayer
 +
|US, F, G, I, S,UK, J
 +
|-
 +
|Miglitol
 +
|Glyset
 +
|Pharmacia
 +
|US, F, G, S
 +
|-
 +
|Voglibose
 +
|Basen, Volix, Vogseal
 +
|Ranbaxy, Nihon Pharmaceutical Industry Ltd
 +
|I, J
 +
|-
 +
|colspan = "4"|<font color="#FF0000">'''Dipeptidyl peptidase-4 (DPP-4) inhibitor'''</font>
 +
|-
 +
|Sitgliptin
 +
|Januvia
 +
|Merck
 +
|US
 +
|-
 +
|}
 +
 
 +
===Products: Fixed Drug Combinations===
 +
{|border="2" cellspacing="0" cellpadding="4" width="100%"
 +
|align = "center" colspan = "4"|<font size = "4">'''Fixed Drug Combinations'''</font>
 +
|-
 +
|bgcolor = "#CCFFFF"|'''Brand Name'''
 +
|bgcolor = "#CCFFFF"|'''Drug 1'''
 +
|bgcolor = "#CCFFFF"|'''Drug 2'''
 +
|bgcolor = "#CCFFFF"|'''Company'''
 +
|-
 +
|Metaglip
 +
|Glipizide
 +
|Metformin
 +
|Bristol-Myers Squibb
 +
|-
 +
|Duetact
 +
|Glimepiride
 +
|Pioglitazone
 +
|Takeda
 +
|-
 +
|Avandaryl
 +
|Glimepiride
 +
|Rosiglitazone
 +
|GlaxoSmithKline
 +
|-
 +
|ACTOSPlusMet
 +
|Pioglitazone
 +
|Metformin
 +
|Takeda
 +
|-
 +
|Avandamet
 +
|Rosiglitazone
 +
|Metformin
 +
|GlaxoSmithKline
 +
|-
 +
|Janumet
 +
|Sitgliptin
 +
|Metformin
 +
|Merck
 +
|-
 +
|}
 +
 
 +
===Product pipeline===
 +
{|border="2" cellspacing="0" cellpadding="4" width="100%"
 +
|align = "center" bgcolor = "#FFFF99" colspan = "3" |<font size = "4">'''Product Pipeline'''</font>
 +
|-
 +
|align = "center" bgcolor = "#FFCC99"|'''Drug'''
 +
|align = "center" bgcolor = "#FFCC99"|'''Company'''
 +
|align = "center" bgcolor = "#FFCC99"|'''Stage'''
 +
 
 +
|-
 +
|align = "center" colspan = "3"|<font color="#FF6600">'''Dipeptidyl Peptidase IV (DPP-IV) Inhibitor '''</font>:DPP-IV inactivates glucagon-like peptide-1 (GLP-1), an important mediator of blood glucose levels following meals. DPP-IV inhibitors have been clinically shown to provide long term improvement of glucose control without the risk of hypoglycemia, and to improve the function of pancreatic beta cells, the cells responsible for the production of insulin.
 +
 
 +
|-
 +
|align = "center"|ALS 2-0426
 +
|align = "center"|<font color="#0000FF"><u>[http://www.amgen.com/investors/pipe.jsp Alantos Pharmaceuticals, Amgen, Servier]</u></font>
 +
|align = "center"|1
 +
 
 +
|-
 +
|align = "center"|PSN9301
 +
|align = "center"|<font color="#0000FF"><u>[http://www.osip.com/PSN9301 OSI]</u></font>
 +
|align = "center"|2
 +
 
 +
|-
 +
|align = "center"|SYR-322
 +
|align = "center"|<font color="#0000FF"><u>[http://findarticles.com/p/articles/mi_m0RSB/is_2006_Jan_21/ai_n16017480 Takeda]</u></font>
 +
|align = "center"|3
 +
 
 +
|-
 +
|align = "center"|R1579
 +
|align = "center"|<font color="#0000FF"><u>[http://www.roche.com/home/investors/inv_pipeline/inv_pipeline_det.htm?ta=Metabolism&Phase=%25&submit=Show+pipeline Roche]</u></font>
 +
|align = "center"|1
 +
 
 +
|-
 +
|align = "center"|vildagliptin (Galvus)
 +
|align = "center"|<font color="#0000FF"><u>[http://www.pharma.us.novartis.com/newsroom/pressReleases/releaseDetail.jsp?PRID=1984 novartis]</u></font>
 +
|align = "center"|NDA submitted in March 2006
 +
 
 +
|-
 +
|align = "center"|MP-513
 +
|align = "center"|<font color="#0000FF"><u>[http://www.m-pharma.co.jp/cgi-bin/pageview.cgi?pass=/e/develop/situation.html Mitsubishi Pharma]</u></font>
 +
|align = "center"|2
 +
 
 +
|-
 +
|align = "center"|Gastrin <nowiki>+</nowiki> DPP IV Inhibitor
 +
|align = "center"|<font color="#0000FF"><u>[http://www.transitiontherapeutics.com/technology/index.php Transition Therapeutics]</u></font>
 +
|align = "center"|2
 +
 
 +
|-
 +
|align = "center"|Saxagliptin
 +
|align = "center"|<font color="#0000FF"><u>[http://www.bms.com/research/content/data/pipeline.html Otsuka Pharmaceutical Co, Bristol-Myers Squibb]</u></font>
 +
|align = "center"|3
 +
 
 +
|-
 +
|colspan = "3"|<font color="#FF6600">'''Insulin sensitizer'''</font>
 +
 
 +
|-
 +
|align = "center"|MBX 102
 +
|align = "center"|<font color="#0000FF"><u>[http://www.medicalnewstoday.com/articles/26017.php Metabolex]</u></font>
 +
|align = "center"|2
 +
 
 +
|-
 +
|align = "center"|MBX-2044
 +
|align = "center"|<font color="#0000FF"><u>[http://www.metabolex.com/pipeline.html Metabolex]</u></font>
 +
|align = "center"|1
 +
 
 +
|-
 +
|align = "center"|ISIS 113715
 +
|align = "center"|<font color="#0000FF"><u>[http://www.isispharm.com/product_pipeline.html Isis]</u></font>
 +
|align = "center"|3
 +
 
 +
|-
 +
|align = "center"|NCX 4016
 +
|align = "center"|<font color="#0000FF"><u>[http://www.nicox.com/update/NCX_4016.html NicOx]</u></font>
 +
|align = "center"|2
 +
 
 +
|-
 +
|align = "center"|Cholebine
 +
|align = "center"|<font color="#0000FF"><u>[http://www.m-pharma.co.jp/cgi-bin/pageview.cgi?pass=/e/develop/situation.html Mitsubishi Pharma]</u></font>
 +
|align = "center"|2
 +
 
 +
|-
 +
|align = "center"|DG070 inhibitors
 +
|align = "center"|<font color="#0000FF"><u>[http://www.develogen.com/en/prod_pipeline.php?hnav=2&tnav=0 Develogen AG]</u></font>
 +
|align = "center"|Preclinical
 +
 
 +
|-
 +
|align = "center"|NovoNorm®/Metformin
 +
|align = "center"|<font color="#0000FF"><u>[http://www.novonordisk.com/science/pipeline/rd_pipeline.asp?showid=6 Novo Nordisk]</u></font>
 +
|align = "center"|3
 +
 
 +
|-
 +
|colspan = "3"|<font color="#FF6600">'''GLP 1 Analogue / Agonists'''</font>
 +
 
 +
|-
 +
|align = "center"|TH0318
 +
|align = "center"|<font color="#0000FF"><u>[http://www.drugresearcher.com/news/ng.asp?id=58974-new-diabetic-drug Theratechnolgies]</u></font>
 +
|align = "center"|1
 +
 
 +
|-
 +
|align = "center"|Liraglutide (NN2211)
 +
|align = "center"|<font color="#0000FF"><u>[http://www.novonordisk.com/science/pipeline/rd_pipeline.asp?showid=4 Novo Nordisk]</u></font>
 +
|align = "center"|3
 +
 
 +
|-
 +
|align = "center"|R1583
 +
|align = "center"|<font color="#0000FF"><u>[http://www.roche.com/home/investors/inv_pipeline/inv_pipeline_det.htm?ta=Metabolism&Phase=%25&submit=Show+pipeline Roche]</u></font>
 +
|align = "center"|2
 +
 
 +
|-
 +
|align = "center"|Oral GLP
 +
|align = "center"|<font color="#0000FF"><u>[http://www.emisphere.com/product_pipeline.asp Emisphere Technologies]</u></font>
 +
|align = "center"|1
 +
 
 +
|-
 +
|align = "center"|PC-DAC™:Exendin-4
 +
|align = "center"|<font color="#0000FF"><u>[http://conjuchem.hyphenhealth.com/ ConjuChem]</u></font>
 +
|align = "center"|2
 +
 
 +
|-
 +
|&nbsp;
 +
|align = "center"|<font color="#0000FF"><u>[http://www.bms.com/research/content/data/pipeline.html Bristol-Myers Squibb ]</u></font>
 +
|align = "center"|Exploratory development
 +
 
 +
|-
 +
|align = "center"|AVE0001A
 +
|align = "center"|<font color="#0000FF"><u>[http://en.sanofi-aventis.com/rd/portfolio/p_rd_portfolio_metabo.asp Sanofi Aventis]</u></font>
 +
|align = "center"|2
 +
 
 +
|-
 +
|align = "center"|Gastrin <nowiki>+</nowiki>GLP 1 Agonist
 +
|align = "center"|<font color="#0000FF"><u>[http://www.transitiontherapeutics.com/technology/index.php Transition Therapeutics]</u></font>
 +
|align = "center"|2
 +
 
 +
|-
 +
|colspan = "3"|<font color="#FF6600">'''Peroxisome Proliferator-Activated Receptor (PPAR)  agonist/analogue'''</font>
 +
 
 +
|-
 +
|align = "center"|AVE8134
 +
|align = "center"|<font color="#0000FF"><u>[http://en.sanofi-aventis.com/rd/portfolio/p_rd_portfolio_metabo.asp Sanofi Aventis]</u></font>
 +
|align = "center"|2
 +
 
 +
|-
 +
|align = "center"|AVE0897
 +
|align = "center"|<font color="#0000FF"><u>[http://en.sanofi-aventis.com/rd/portfolio/p_rd_portfolio_metabo.asp Sanofi Aventis]</u></font>
 +
|align = "center"|1
 +
 
 +
|-
 +
|align = "center"|R1439, aleglitazar
 +
|align = "center"|<font color="#0000FF"><u>[http://www.roche.com/home/investors/inv_pipeline/inv_pipeline_det.htm?ta=Metabolism&Phase=%25&submit=Show+pipeline Roche]</u></font>
 +
|align = "center"|2
 +
 
 +
|-
 +
|align = "center"|AVE0847
 +
|align = "center"|<font color="#0000FF"><u>[http://en.sanofi-aventis.com/rd/portfolio/p_rd_portfolio_metabo.asp Sanofi Aventis]</u></font>
 +
|align = "center"|2
 +
 
 +
|-
 +
|align = "center"|SAR351034
 +
|align = "center"|<font color="#0000FF"><u>[http://en.sanofi-aventis.com/rd/portfolio/p_rd_portfolio_metabo.asp Sanofi Aventis]</u></font>
 +
|align = "center"|Preclinical
 +
 
 +
|-
 +
|align = "center"|376501
 +
|align = "center"|<font color="#0000FF"><u>[http://www.gsk.com/investors/pp_pipeline_standard.htm Glaxosmithkline]</u></font>
 +
|align = "center"|1
 +
 
 +
|-
 +
|align = "center"|625019
 +
|align = "center"|<font color="#0000FF"><u>[http://www.gsk.com/investors/pp_pipeline_standard.htm Glaxosmithkline]</u></font>
 +
|align = "center"|1
 +
 
 +
|-
 +
|align = "center"|677954
 +
|align = "center"|<font color="#0000FF"><u>[http://www.gsk.com/investors/pp_pipeline_standard.htm Glaxosmithkline]</u></font>
 +
|align = "center"|2
 +
 
 +
|-
 +
|align = "center"|Avandia
 +
|align = "center"|<font color="#0000FF"><u>[http://www.gsk.com/investors/pp_pipeline_standard.htm Glaxosmithkline]</u></font>
 +
|align = "center"|2
 +
 
 +
|-
 +
|align = "center"|Avandia XR
 +
|align = "center"|<font color="#0000FF"><u>[http://www.gsk.com/investors/pp_pipeline_standard.htm Glaxosmithkline]</u></font>
 +
|align = "center"|2
 +
 
 +
|-
 +
|align = "center"|PPAR Gamma Agonist <nowiki>+</nowiki> simvaststin
 +
|align = "center"|<font color="#0000FF"><u>[http://www.gsk.com/investors/pp_pipeline_standard.htm Glaxosmithkline]</u></font>
 +
|align = "center"|3
 +
 
 +
|-
 +
|align = "center"|MCC-555, Netoglitazone
 +
|align = "center"|<font color="#0000FF"><u>[http://www.m-pharma.co.jp/cgi-bin/pageview.cgi?pass=/e/develop/situation.html Mitsubishi Pharma, Novartis]</u></font>
 +
|align = "center"|&nbsp;
 +
 
 +
|-
 +
|align = "center"|Muraglitzar
 +
|align = "center"|<font color="#0000FF"><u>[http://www.drugs.com/nda/muraglitazar_041223.html Bristol-Myers Squibb ]</u></font>
 +
|align = "center"|3
 +
 
 +
|-
 +
|colspan = "3"|<font color="#FF6600">'''Oral glucokinase activator (GKA)'''</font>
 +
 
 +
|-
 +
|align = "center"|PSN010
 +
|align = "center"|<font color="#0000FF"><u>[http://www.osip.com/PSN010 OSI]</u></font>
 +
|align = "center"|1
 +
 
 +
|-
 +
|align = "center"|R1511
 +
|align = "center"|<font color="#0000FF"><u>[http://www.roche.com/home/investors/inv_pipeline/inv_pipeline_det.htm?ta=Metabolism&Phase=%25&submit=Show+pipeline Roche]</u></font>
 +
|align = "center"|1
 +
 
 +
|-
 +
|colspan = "3"|<font color="#FF6600">'''G protein-coupled Receptor(GPR) 119 Agonist'''</font>
 +
 
 +
|-
 +
|align = "center"|PSN821
 +
|align = "center"|<font color="#0000FF"><u>[http://www.osip.com/PSN010 OSI]</u></font>
 +
|align = "center"|&nbsp;
 +
 
 +
|-
 +
|colspan = "3"|<font color="#FF6600">'''β3-Adrenergic Receptor Agonist'''</font>
 +
 
 +
|-
 +
|align = "center"|Solabegron (GW427353)
 +
|align = "center"|<font color="#0000FF"><u>[http://clinicaltrials.gov/ct/gui/show/NCT00401479?order=1 Glaxosmithkline]</u></font>
 +
|align = "center"|1
 +
 
 +
|-
 +
|colspan = "3"|<font color="#FF6600">'''Antisense drug for Glucagon Receptor (GCGR)'''</font>
 +
 
 +
|-
 +
|align = "center"|ISIS 325568
 +
|align = "center"|<font color="#0000FF"><u>[http://www.isispharm.com/product_pipeline.html Isis]</u></font>
 +
|align = "center"|1
 +
 
 +
|-
 +
|align = "center"|ISIS 377131
 +
|align = "center"|<font color="#0000FF"><u>[http://www.isispharm.com/product_pipeline.html Isis]</u></font>
 +
|align = "center"|Preclinical
 +
 
 +
|-
 +
|colspan = "3"|<font color="#FF6600">''' Sodium Glucose Transporter 2 (SGLT2) inhibitor'''</font>
 +
 
 +
|-
 +
|align = "center"|AVE2268
 +
|align = "center"|<font color="#0000FF"><u>[http://en.sanofi-aventis.com/rd/portfolio/p_rd_portfolio_metabo.asp Sanofi Aventis]</u></font>
 +
|align = "center"|2
 +
 
 +
|-
 +
|align = "center"|SAR 7226
 +
|align = "center"|<font color="#0000FF"><u>[http://en.sanofi-aventis.com/rd/portfolio/p_rd_portfolio_metabo.asp Sanofi Aventis]</u></font>
 +
|align = "center"|Preclinical
 +
 
 +
|-
 +
|align = "center"|189075
 +
|align = "center"|<font color="#0000FF"><u>[http://clinicaltrials.gov/ct/gui/show/NCT00401479?order=1 Glaxosmithkline]</u></font>
 +
|align = "center"|2
 +
 
 +
|-
 +
|colspan = "3"|<font color="#FF6600">'''N-methyl-D-aspartic acid (NMDA) receptor antagonist'''</font>
 +
 
 +
|-
 +
|align = "center"|Perzinfotel
 +
|align = "center"|Wyeth
 +
|align = "center"|2
 +
 
 +
|-
 +
|colspan = "3"|<font color="#FF6600">'''Growth hormone releasing analogue'''</font>
 +
 
 +
|-
 +
|align = "center"|TH 9507
 +
|align = "center"|<font color="#0000FF"><u>[http://www.theratech.com/en/products-therapeutic-peptides/pipeline.php Theratechnolgies]</u></font>
 +
|align = "center"|&nbsp;
 +
 
 +
|-
 +
|colspan = "3"|<font color="#FF6600">'''Aldolase reductase inhibitor'''</font>
 +
 
 +
|-
 +
|align = "center"|SNK-860,  fidarestat
 +
|align = "center"|<font color="#0000FF"><u>[http://care.diabetesjournals.org/cgi/reprint/24/10/1776.pdf Sankyo]</u></font>
 +
|align = "center"|3
 +
 
 +
|-
 +
|colspan = "3"|<font color="#FF6600">'''Neurotrophin Enhancer'''</font>
 +
 
 +
|-
 +
|align = "center"|MCC-257
 +
|align = "center"|<font color="#0000FF"><u>[http://www.m-pharma.co.jp/cgi-bin/pageview.cgi?pass=/e/develop/situation.html Mitsubishi Pharma]</u></font>
 +
|align = "center"|2
 +
 
 +
|-
 +
|colspan = "3"|<font color="#FF6600">'''Nitric oxide (NO) blocking agent'''</font>
 +
 
 +
|-
 +
|align = "center"|NOX-700
 +
|align = "center"|<font color="#0000FF"><u>[http://www.medinox.com/news/press.htm Medinox]</u></font>
 +
|align = "center"|1 staretd in 2002
 +
 
 +
|-
 +
|colspan = "3"|<font color="#FF6600">'''Antibody'''</font>
 +
 
 +
|-
 +
|align = "center"|TRX4
 +
|align = "center"|<font color="#0000FF"><u>[http://www.btgplc.com/PartneredDevelopment/240/TRX4.html BTG]</u></font>
 +
|align = "center"|2
 +
 
 +
|-
 +
|colspan = "3"|<font color="#FF6600">'''11-beta hydroxysteroid dehydrogenase type 1 (11ß-HSD1) inhibitor'''</font>
 +
 
 +
|-
 +
|align = "center"|AMG 221
 +
|align = "center"|<font color="#0000FF"><u>[http://wwwext.amgen.com/science/pipe_AMG221.html Amgen]</u></font>
 +
|align = "center"|1
 +
 
 +
|-
 +
|colspan = "3"|<font color="#FF6600">'''Polypyrimidine tract binding protein (PTB, also named hnRNP) inhibitor'''</font>
 +
 
 +
|-
 +
|align = "center"|&nbsp;
 +
|align = "center"|Serono
 +
|align = "center"|1
 +
|-
 +
|colspan = "3"|<font color="#FF6600">'''Insulin Like Growth Factor 1'''</font>
 +
|-
 +
|-
 +
|align = "center"|IPLEX
 +
|align = "center"|Glen Allen
 +
|align = "center"|Orphan Drug Status
 +
|-
 +
|bgcolor = "#FFFF99" colspan = "3"|<font color="#FF6600">'''Miscellaneous'''</font>
 +
 
 +
|-
 +
|align = "center"|&nbsp;
 +
|align = "center"|<font color="#0000FF"><u>[http://www.metabolex.com/pipeline.html Metabolex]</u></font>
 +
|align = "center"|1
 +
 
 +
|-
 +
|align = "center"|MBX-8025
 +
|align = "center"|<font color="#0000FF"><u>[http://www.metabolex.com/MBX-8025.html Metabolex]</u></font>
 +
|align = "center"|2
 +
 
 +
|-
 +
|align = "center"|Nateglinide with insulin sensitizers
 +
|align = "center"|<font color="#0000FF"><u>[http://www.astellas.com/global/about/news/2006/pdf/061130_eg.pdf Astellas pharmas]</u></font>
 +
|align = "center"|SNDA Filed
 +
 
 +
|-
 +
|align = "center"|Nateglinide with biguanides
 +
|align = "center"|<font color="#0000FF"><u>[http://www.astellas.com/global/about/news/2006/pdf/061130_eg.pdf Astellas pharmas]</u></font>
 +
|align = "center"|SNDA Filed
 +
 
 +
|-
 +
|align = "center"|&nbsp;
 +
|align = "center"|&nbsp;
 +
|align = "center"|&nbsp;
 +
 
 +
|-
 +
|align = "center"|869682
 +
|align = "center"|<font color="#0000FF"><u>[http://clinicaltrials.gov/ct/gui/show/NCT00291356?order=2 Glaxosmithkline]</u></font>
 +
|align = "center"|2
 +
 
 +
|-
 +
|align = "center"|815541
 +
|align = "center"|<font color="#0000FF"><u>[http://www.chartsbank.com/PipelineList.aspx Glaxosmithkline]</u></font>
 +
|align = "center"|1
 +
 
 +
|-
 +
|align = "center"|625019
 +
|align = "center"|<font color="#0000FF"><u>[http://www.chartsbank.com/PipelineList.aspx Glaxosmithkline]</u></font>
 +
|align = "center"|1
 +
 
 +
|-
 +
|align = "center"|189075
 +
|align = "center"|<font color="#0000FF"><u>[http://www.chartsbank.com/PipelineList.aspx Glaxosmithkline]</u></font>
 +
|align = "center"|1
 +
 
 +
|-
 +
|align = "center"|677954
 +
|align = "center"|<font color="#0000FF"><u>[http://www.chartsbank.com/PipelineList.aspx Glaxosmithkline]</u></font>
 +
|align = "center"|2
 +
 
 +
|-
 +
|align = "center"|PPM-204
 +
|align = "center"|<font color="#0000FF"><u>[http://www.wyeth.com/research/pipeline Wyeth]</u></font>
 +
|align = "center"|2
 +
 
 +
|-
 +
|align = "center"|CS-011 (Roviglitazone)
 +
|align = "center"|Sankyo
 +
|align = "center"|2
 +
 
 +
|-
 +
|align = "center"|ACOMPLIA®( Rimonabant*)
 +
|align = "center"|<font color="#0000FF"><u>[http://en.sanofi-aventis.com/rd/portfolio/p_rd_portfolio_metabo.asp Sanofi Aventis]</u></font>
 +
|align = "center"|3
 +
 
 +
|-
 +
|align = "center"|CS-917
 +
|align = "center"|Sankyo
 +
|align = "center"|2
 +
 
 +
|-
 +
|align = "center"|R 1499
 +
|align = "center"|<font color="#0000FF"><u>[http://www.chartsbank.com/PipelineList.aspx Roche]</u></font>
 +
|align = "center"|1
 +
 
 +
|-
 +
|align = "center"|R1438
 +
|align = "center"|<font color="#0000FF"><u>[http://www.chartsbank.com/PipelineList.aspx Roche]</u></font>
 +
|align = "center"|2
 +
 
 +
|-
 +
|align = "center"|R483
 +
|align = "center"|<font color="#0000FF"><u>[http://www.chartsbank.com/PipelineList.aspx Roche]</u></font>
 +
|align = "center"|2
 +
 
 +
|-
 +
|align = "center"|R1440
 +
|align = "center"|<font color="#0000FF"><u>[http://www.chartsbank.com/PipelineList.aspx Roche]</u></font>
 +
|align = "center"|2
 +
 
 +
|-
 +
|align = "center"|PSN 357
 +
|align = "center"|OSI
 +
|align = "center"|1
 +
 
 +
|-
 +
|align = "center"|NBI 6024
 +
|align = "center"|Neurocrine Biosciences
 +
|align = "center"|2
 +
 
 +
|-
 +
|align = "center"|CS-917
 +
|align = "center"|<font color="#0000FF"><u>[http://www.mbasis.com/pipeline/index.html metabasis, Daiichi Sankyo]</u></font>
 +
|align = "center"|2
 +
 
 +
|-
 +
|align = "center"|MB07803
 +
|align = "center"|<font color="#0000FF"><u>[http://www.mbasis.com/pipeline/index.html metabasis, Daiichi Sankyo]</u></font>
 +
|align = "center"|2
 +
 
 +
|-
 +
|align = "center"|AMPK Project
 +
|align = "center"|<font color="#0000FF"><u>[http://www.mbasis.com/pipeline/index.html metabasis, Daiichi Sankyo]</u></font>
 +
|align = "center"|Discovery
 +
 
 +
|-
 +
|align = "center"|MK 0941
 +
|align = "center"|<font color="#0000FF"><u>[http://www.merck.com/finance/pipeline.swf  Merck]</u></font>
 +
|align = "center"|1
 +
 
 +
|-
 +
|align = "center"|MK 1642
 +
|align = "center"|<font color="#0000FF"><u>[http://www.merck.com/finance/pipeline.swf  Merck]</u></font>
 +
|align = "center"|1
 +
 
 +
|-
 +
|align = "center"|Mk 0533
 +
|align = "center"|<font color="#0000FF"><u>[http://www.merck.com/finance/pipeline.swf  Merck]</u></font>
 +
|align = "center"|2
 +
 
 +
|-
 +
|align = "center"|MK0893
 +
|align = "center"|<font color="#0000FF"><u>[http://www.merck.com/finance/pipeline.swf  Merck]</u></font>
 +
|align = "center"|2
 +
 
 +
|-
 +
|align = "center"|Arxxant (ruboxistaurin)
 +
|align = "center"|<font color="#0000FF"><u>[http://investor.lilly.com/pipeline.cfm Eli Lilly]</u></font>
 +
|align = "center"|3
 +
 
 +
|-
 +
|align = "center"|11 B- HSD 1
 +
|align = "center"|<font color="#0000FF"><u>[http://www.biovitrum.com/upload/images/R&D/Projectportfolio_June_2007.pdf Biovitrum,  Amgen]</u></font>
 +
|align = "center"|1
 +
 
 +
|-
 +
|align = "center"|Gastrin <nowiki>+</nowiki> Metformin
 +
|align = "center"|<font color="#0000FF"><u>[http://www.transitiontherapeutics.com/technology/index.php Transition Therapeutics]</u></font>
 +
|align = "center"|1
 +
 
 +
|-
 +
|align = "center"|AMG 837
 +
|align = "center"|<font color="#0000FF"><u>[http://wwwext.amgen.com/science/pipe_AMG221.html Amgen]</u></font>
 +
|align = "center"|1
 +
 
 +
|-
 +
|align = "center"|Darbepoetin alfa
 +
|align = "center"|<font color="#0000FF"><u>[http://wwwext.amgen.com/science/pipe_AMG221.html Amgen]</u></font>
 +
|align = "center"|3
 +
 
 +
|-
 +
|align = "center"|Smylin(Amylin analogue)
 +
|align = "center"|<font color="#0000FF"><u>[http://www.amylin.com/pipeline/symlin.cfm Amylin]</u></font>
 +
|align = "center"|4
 +
 
 +
|-
 +
|align = "center"|Exenatide LAR
 +
|align = "center"|<font color="#0000FF"><u>[http://www.amylin.com/pipeline/symlin.cfm Amylin]</u></font>
 +
|align = "center"|2
 +
 
 +
|-
 +
|align = "center"|DG770 (beta cell regeneration factor)
 +
|align = "center"|<font color="#0000FF"><u>[http://www.develogen.com/en/prod_pipeline.php?hnav=2&tnav=0 Develogen AG]</u></font>
 +
|align = "center"|3
 +
 
 +
|-
 +
|align = "center"|E1 INT (Islet regeneration)
 +
|align = "center"|<font color="#0000FF"><u>[http://www.transitiontherapeutics.com/technology/index.php Transition Therapeutics]</u></font>
 +
|align = "center"|2
 +
 
 +
|-
 +
|align = "center"|Mecasermin rinfabate (IPLEX) (IGF 1 and 2)
 +
|align = "center"|<font color="#0000FF"><u>[http://www.fda.gov/cder/drug/InfoSheets/patient/mecasermin_rinfabatePIS.htm Insmed]</u></font>
 +
|align = "center"|Approved in 2005
 +
 
 +
|-
 +
|align = "center"|Orlistat (Xenical) (Lipase inhibitor)
 +
|align = "center"|<font color="#0000FF"><u>[http://www.xenical.com/xen_do_home.asp Roche]</u></font>
 +
|align = "center"|&nbsp;
 +
 
 +
|-
 +
|align = "center" bgcolor = "#FFFF99" colspan = "3"|<font color="#FF0000"><font size = "4">'''Insulins'''</font></font>
 +
 
 +
|-
 +
|align = "center"|Oral Insulin
 +
|align = "center"|<font color="#0000FF"><u>[http://www.emisphere.com/pc_oi.asp Emisphere Technologies]</u></font>
 +
|align = "center"|2
 +
 
 +
|-
 +
|align = "center"|Technosphere
 +
|align = "center"|<font color="#0000FF"><u>[http://www.mannkindcorp.com/technosphere_insulin.aspx Mannkind corporation]</u></font>
 +
|align = "center"|3
 +
 
 +
|-
 +
|align = "center"|NN344 (Insulin analogue)
 +
|align = "center"|<font color="#0000FF"><u>[http://www.novonordisk.com/science/pipeline/rd_pipeline.asp?showid=18 Novo Nordisk]</u></font>
 +
|align = "center"|1
 +
 
 +
|-
 +
|align = "center"|NN5401(Insulin analogue)
 +
|align = "center"|<font color="#0000FF"><u>[http://www.novonordisk.com/science/pipeline/rd_pipeline.asp?showid=19 Novo Nordisk]</u></font>
 +
|align = "center"|1
 +
 
 +
|-
 +
|align = "center"|AERx® iDMS (Insulin Inhalation system)
 +
|align = "center"|<font color="#0000FF"><u>[http://www.novonordisk.com/science/pipeline/rd_pipeline.asp?showid=5 Novo Nordisk]</u></font>
 +
|align = "center"|3
 +
 
 +
|-
 +
|align = "center"|Inhaled insulin
 +
|align = "center"|Bristol Meyers Squibb
 +
|align = "center"|1
 +
 
 +
|-
 +
|align = "center"|Inhaled insulin
 +
|align = "center"|<font color="#0000FF"><u>[http://investor.lilly.com/pipeline.cfm Eli Lilly]</u></font>
 +
|align = "center"|2
 +
 
 +
|-
 +
|align = "center"|Exubera (Inhaled insulin)
 +
|align = "center"|<font color="#0000FF"><u>[http://www.pfizer.com/research/cardiovascular_condition.jsp Pfizer]</u></font>
 +
|align = "center"|4
 +
 
 +
|-
 +
|align = "center"|Oal Lyn (Inhaled insulin)
 +
|align = "center"|<font color="#0000FF"><u>[http://www.generex.com/products/oral-lyn/ http://www.generex.com/products/oral-lyn/]</u></font>
 +
|align = "center"|Approved in Ecuador
 +
 
 +
|-
 +
|align = "center"|Nasulin
 +
|align = "center"|<font color="#0000FF"><u>[http://www.bentleypharm.com/other/pipeline Bentley]</u></font>
 +
|align = "center"|2
 +
 
 +
|}
 +
 
 +
==Intellectual Property==
 +
===Search strategy===
 +
* '''Database/Vendor:''' Micropat
 +
* '''Search scope:''' US Granted US Applications EP-A EP-B WO JP (bibliographic data only) DE-C,B DE-A DE-T DE-U GB-A FR-A; '''English Title'''
 +
* '''Years:''' '''Issue/Publication Date:''' >20051231
 +
* '''String:''' (Diabetes OR diabetic) AND (treatment OR treating)
 +
* '''Hits:''' 618/217 patents (with/with out family members)
 +
* '''Date of search:''' 11 July 2007
 +
 
 +
===Top players and IPC classes===
 +
 
 +
[[Image:Diabetes- top players.jpeg|center|850 px|]]
 +
 
 +
====IPC code definition====
 +
 
 +
{|border="0" cellspacing="1" width="80%"
 +
|'''A61K'''
 +
|Preparations for medical, dental, or toilet purposes
 +
|-
 +
|'''C07D'''
 +
|Heterocyclic compounds
 +
|-
 +
|'''C07K'''
 +
|Peptides
 +
|-
 +
|'''C12N'''
 +
|Micro-organisms or enzymes; compositions thereof
 +
|-
 +
|'''C12Q'''
 +
|Measuring or testing processes involving enzymes or micro-organisms  (immunoassay); compositions or test papers therefor; processes of preparing such compositions; condition-responsive control in microbiological or enzymological processes
 +
|-
 +
|}
 +
 
 +
===Geographical Distribution and Treatment Approaches===
 +
 
 +
[[Image:Diabetes -geographical.jpeg|center|850 px|]]
 +
 
 +
===IP activity and Treatment Approaches===
 +
[[Image:Diabetes -year approach.jpeg|center|850 px|]]
 +
 
 +
==Clinical Trials==
 +
===Approved/On-going===
 +
{|border="2" cellspacing="0" cellpadding="4" width="100%"
 +
|align = "center" bgcolor = "#FFFF99" colspan = "5"|<font size = "4">'''Clinical trials'''</font>
 +
|-
 +
|align = "center"|<font color="#0000FF">'''Drug'''</font>
 +
|align = "center"|<font color="#0000FF">'''Sponsors'''</font>
 +
|align = "center"|<font color="#0000FF">'''Description'''</font>
 +
|align = "center"|<font color="#0000FF">'''Phase'''</font>
 +
|align = "center"|<font color="#0000FF">'''Date of Start'''</font>
 +
|-
 +
|align = "center" colspan = "5"|<font color="#FF0000"><font size = "4">'''Oral Drugs'''</font></font>
 +
|-
 +
|align = "center" colspan = "5"|<font color="#FF0000">'''Cannabinoid receptor antagonist'''</font>
 +
|-
 +
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00478595?order=1 Rimonabant]
 +
|align = "justify"|Sanofi-Aventis
 +
|align = "justify"|The primary objective of this study is to assess the efficacy of SR141716 (rimonabant) compared to placebo on change in HbA1c and on relative change in body weight over 52 weeks in obese type 2 diabetic patients on monotherapy inadequately controlled with oral anti-diabetic drug (sulfonylurea or ?-glucosidase inhibitor).
 +
|align = "center"|3
 +
|align = "center"|May-07
 +
|-
 +
|align = "center" colspan = "5"|<font color="#FF0000">'''Insulin Sensitisers'''</font>
 +
|-
 +
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00353587?order=24 Metaglidasen]
 +
|align = "justify"|Metabolex
 +
|align = "justify"|
 +
|align = "center"|2, 3
 +
|align = "center"|May-06
 +
|-
 +
|align = "center" colspan = "5"|<font color="#FF0000">'''Thioglitazone'''</font>
 +
|-
 +
|align = "justify"|[http://clinicaltrials.gov/ct/show/NCT00386100?order=1 Rosiglitazone maleate/metformin hydrochloride (AVANDAMET)]
 +
|align = "justify"|GlaxoSmithKline
 +
|align = "justify"|This study will evaluate the longer-term glycemic effect of two medicines approved for initial treatment of type 2 diabetes.
 +
|align = "center"|4
 +
|align = "center"|Oct-06
 +
|-
 +
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00515632?order=8 Balaglitazone]
 +
|align = "justify"|Rheoscience A/S
 +
|align = "justify"|Balaglitazone is a thiazolidinedione derivative that is being developed as an oral anti-diabetic drug to improve blood glucose control in patients with type 2 diabetes. The purpose of this study is to assess if additional treatment with balaglitazone in patients with type 2 diabetes on stable insulin treatment will improve blood glucose control and decrease the daily insulin dose, but with less impact on weight gain and oedema.
 +
|align = "center"|3
 +
|align = "center"|Jul-07
 +
|-
 +
|align = "center" colspan = "5"|<font color="#FF0000">'''(DPP-4) inhibitor'''</font>
 +
|-
 +
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00351884?order=18 Vildagliptin]
 +
|align = "justify"|Novartis
 +
|align = "justify"|This is a 24-week study to assess the efficacy on HbA1c of 100 mg vildagliptin once daily as compared to placebo as add-on to metformin in patients with type 2 diabetes inadequately controllled with metformin.
 +
|align = "center"|3
 +
|align = "center"|May-06
 +
|-
 +
|align = "center" colspan = "5"|<font color="#FF0000">'''Insulin'''</font>
 +
|-
 +
|align = "justify"|[http://clinicaltrials.gov/ct/show/NCT00419562?order=1 Oral Insulin]
 +
|align = "justify"|NIDDK, NICHD, NIAID, NICR, ADA, JDRF
 +
|align = "justify"|N/A
 +
|align = "center"|3
 +
|align = "center"|Feb-07
 +
|-
 +
|align = "center" colspan = "5"|<font color="#FF0000">'''Potassium Channel Blocker'''</font>
 +
|-
 +
|align = "justify"|[http://clinicaltrials.gov/ct/show/NCT00131755?order=1 Diazoxide]
 +
|align = "justify"|Grill, Valdemar, M.D.
 +
|align = "justify"|The purpose of this study is to find out if Diazoxide can partly retain insulin production in newly diagnosed type 1 diabetes patients.
 +
|align = "center"|4
 +
|align = "center"|Feb-05
 +
|-
 +
|align = "center" colspan = "5"|<font color="#FF0000">'''Nutritional Agents'''</font>
 +
|-
 +
|align = "justify"|[http://clinicaltrials.gov/ct/show/NCT00117026?order=1 Benfotiamine (Vitamin B1)]
 +
|align = "justify"|University Hospital, Aker, The Research Council of Norway
 +
|align = "justify"|N/A
 +
|align = "center"|1, 2
 +
|align = "center"|Aug-05
 +
|-
 +
|align = "justify"|[http://clinicaltrials.gov/ct/show/NCT00333554?order=1 Docosahexaenoic acid (DHA)]
 +
|align = "justify"|NIDDK
 +
|align = "justify"|N/A
 +
|align = "center"|2
 +
|align = "center"| June 2006
 +
|-
 +
|align = "justify"|[http://clinicaltrials.gov/ct/show/NCT00400491?order=1 Vitamin D]
 +
|align = "justify"|University of Tromso
 +
|align = "justify"|The purpose of the study is to evaluate if supplementation with vitamin D in a dose of 40.000 IU per week will result in improved metablic control in patients with type 2 diabetes.
 +
|align = "center"|2
 +
|align = "center"|Jun-06
 +
|-
 +
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00351234?order=25 Carnitine Supplementation]
 +
|align = "justify"|Children<nowiki>’</nowiki>s Mercy Hospital Kansas City,Sigma Tau Pharmaceuticals, Inc, Minimed Pharmaceuticals, Pharmacia/Upjohn Career Development Award
 +
|align = "justify"|The purpose of this study is to determine whether type I diabetics with carnitine deficiency exhibit increased numbers of hypoglycemic (low blood sugars) events and if unrecognized hypoglycemia occurs during continuous 72-hour glucose monitoring. If they are determined to have unrecognized hypoglycemia, then oral carnitine supplementation will be given to those subjects and they will be reassessed for the number of hypoglycemic events in a 72-hour glucose monitoring.
 +
|align = "center"|
 +
|align = "center"|Oct-04
 +
|-
 +
|align = "center" colspan = "5"|<font color="#FF0000">'''Antiinflammatory'''</font>
 +
|-
 +
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00339833?order=63 Salsalate]
 +
|align = "justify"|NIDDK,National Institutes of Health Clinical Center
 +
|align = "justify"|This study, conducted at the Phoenix Indian Medical Center, Phoenix, Arizona, will determine whether reducing subclinical inflammation lessens insulin resistance in healthy, obese volunteers.
 +
|align = "center"|4
 +
|align = "center"|Mar-03
 +
|-
 +
|align = "center" colspan = "5"|<font color="#FF0000">'''Angiotensin (AT 2) Antagonist/blocker'''</font>
 +
|-
 +
|align = "justify"| Olmesartan
 +
|align = "justify"|Daiichi Sankyo Inc
 +
|align = "justify"|N/A
 +
|align = "center"|3
 +
|align = "center"|Oct-04
 +
|-
 +
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00422487?order=35 MBX-2044]
 +
|align = "justify"|Metabolex
 +
|align = "justify"|The purpose of this study is to collect important information regarding the glucose-lowering efficacy of MBX-2044 and the safety of MBX-2044 (especially weight gain and edema) in diabetics. It will also provide important information about the appropriate doses to be used in subsequent longer-term studies to evaluate the safety and efficacy of MBX-2044 alone and in combination with other anti-diabetic agents.
 +
|align = "center"|2
 +
|align = "center"|Oct-06
 +
|-
 +
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00473525?order=39 PF-00734200]
 +
|align = "justify"|Pfizer
 +
|align = "justify"|The purpose of this Phase 2a study is to evaluate the efficacy, safety and tolerability, of multiple parallel doses of PF-00734200 following oral administration to adult human subjects with T2DM who currently are on a stable dose of metformin.
 +
|align = "center"|2
 +
|align = "center"|Jun-07
 +
|-
 +
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00391196?order=41 CP-945,598]
 +
|align = "justify"|Pfizer
 +
|align = "justify"|The purpose of this study is to determine if CP-945,598 is effective in the treatment of obesity in type 2 diabetic patients
 +
|align = "center"|3
 +
|align = "center"|Nov-06
 +
|-
 +
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00147745?order=46 WelChol® (colesevelam)]
 +
|align = "justify"|Daiichi Sankyo Inc
 +
|align = "justify"|This study is designed to assess the potential mechanism of action by which WelChol® (colesevelam) may improve blood glucose control in patients with type 2 diabetes
 +
|align = "center"|2
 +
|align = "center"|May-05
 +
|-
 +
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00461006?order=61 Aleglitazar and Actos®]
 +
|align = "justify"|Hoffmann-La Roche
 +
|align = "justify"|This study will compare the effects of aleglitazar and Actos®, added to preexisting oral antihyperglycemic therapy and/or diet and exercise, on renal function in patients with type 2 diabetes, and normal or mildly impaired renal function.
 +
|align = "center"|2
 +
|align = "center"| June 2007
 +
|-
 +
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00328172?order=67 BI 1356 BS]
 +
|align = "justify"|Boehringer Ingelheim Pharmaceuticals
 +
|align = "justify"|The objective of this monotherapy study is to investigate the efficacy, safety, and tolerability of 3 doses of BI 1356 BS compared to placebo over 12 weeks of treatment in patients with type 2 diabetes and insufficient control of thier blood glucose. In addition, there will be an open-label treatment arm with metformin. The hypothesis of the trial is that the test drug, BI 1356 BS will lead to better control of blood glucose compared to placebo after 12 weeks of treatment.
 +
|align = "center"|2
 +
|align = "center"|May-06
 +
|-
 +
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00357370?order=84 BMS-512148]
 +
|align = "justify"|Bristol-Myers Squibb
 +
|align = "justify"|The purpose of this clinical research study is to learn if BMS-512148, added to insulin and one or two anti-diabetes medications (metformin and/or pioglitazone or rosiglitazone), can help reduce the blood sugar levels compared to insulin and one or two anti-diabetes medications (metformin and/or pioglitazone or rosiglitazone) alone, in subjects with type 2 diabetes.
 +
|align = "center"|2, 3
 +
|align = "center"| October 2006
 +
|-
 +
|align = "center" colspan = "5"|<font color="#FF0000"><font size = "4">'''Parenteral routes'''</font></font>
 +
|-
 +
|align = "center" colspan = "5"|<font color="#FF0000">'''Insulins'''</font>
 +
|-
 +
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00349986?order=3 Insuline glargine]
 +
|align = "justify"|Sanofi-Aventis
 +
|align = "justify"|Purpose ogf this study is to determine rhe first dose and titration of basal insulin
 +
|align = "center"|4
 +
|align = "center"|May-06
 +
|-
 +
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00360698?order=2 Basal Insulin Plus Insulin Glulisine]
 +
|align = "justify"|Sanofi-Aventis
 +
|align = "justify"|To evaluate the efficacy of a single injection of glulisine before the main meal added to insulin glargine plus oral antidiabetic drugs (OADs) compared to insulin glargine plus OADs in Type 2 diabetic patients poorly controlled with basal insulin plus OADs.
 +
|align = "center"|4
 +
|align = "center"|Jul-06
 +
|-
 +
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00282971?order=10 Inhaled Insulin (Exubera)]
 +
|align = "justify"|Pfizer
 +
|align = "justify"|To assess the impact on glucose control by inhaled insulin in patients with type 2 diabetes who are not well controlled on 2 or more oral anti-diabetic agents
 +
|align = "center"|3
 +
|align = "center"|Mar-06
 +
|-
 +
|align = "justify"|[http://clinicaltrials.gov/ct/show/NCT00325364?order=1 Insulin Inhalation Powder]
 +
|align = "justify"|Eli Lilly and Company
 +
|align = "justify"|This is a phase 3, open-label, randomized study to evaluate the safety and efficacy of the Lilly/Alkermes inhaled insulin system compared to injected pre-meal insulin in non-smoking patients with type 2 diabetes. Patients will be treated for 24 months with a 2-month follow-up period.
 +
|align = "center"|3
 +
|align = "center"|Apr-06
 +
|-
 +
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00455858?order=51 Levemir]
 +
|align = "justify"|Novo Nordisk
 +
|align = "justify"|This trial aims for a comparison of the effect on glycaemic control in subjects with type 2 diabetes under both established Western algorithm and Korean practical algorithm, given in combination with oral diabetic drug(s)
 +
|align = "center"|4
 +
|align = "center"|Aug-07
 +
|-
 +
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00228878?order=69 Pulsatile IV Insulin]
 +
|align = "justify"|Florida Atlantic University
 +
|align = "justify"|The purpose of this study is to determine if restoring normal metabolic function in patients with either type I or type II diabetes can improve the impact of the consequences of diabetic complications on the overall quality of life of diabetic patients. Patients are treated once a week with pulsatile intravenous insulin therapy mimicking normal insulin secretion.
 +
|align = "center"|2, 3
 +
|align = "center"|Mar-03
 +
|-
 +
|align = "center" colspan = "5"|<font color="#FF0000">'''Incretin Minetic'''</font>
 +
|-
 +
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00360334?order=9 Exenatide With Basal Insulin]
 +
|align = "justify"|Amylin Pharmaceuticals, Eli Lilly
 +
|align = "justify"|This is a phase 3 trial designed to compare the effects of twice daily exenatide plus oral antidiabetic agents (OADs) and once-daily insulin glargine plus OADs with respect to glycemic control, as measured by hemoglobin A1c, with minimum weight gain, in patients with uncontrolled type 2 diabetes on OADs.
 +
|align = "center"|3
 +
|align = "center"|Jun-06
 +
|-
 +
|align = "justify"|[http://clinicaltrials.gov/ct/show/NCT00456300?order=1 Exenatide]
 +
|align = "justify"|Baylor College of Medicine, NIH
 +
|align = "justify"|The purpose of this study is to see if giving exenatide and insulin before a meal would lower blood sugars after the meal.
 +
|align = "center"|4
 +
|align = "center"|Mar-07
 +
|-
 +
|align = "justify"|[http://clinicaltrials.gov/ct/gui/show/NCT00434954?order=11 Exenatide Plus Metformin vs. Insulin Aspart Plus Metformin]
 +
|align = "justify"|Amylin Pharmaceuticals, Eli Lilly
 +
|align = "justify"|This study in Germany is designed to compare the effects of twice-daily exenatide plus metformin and twice-daily premixed human insulin aspart plus metformin with respect to glycemic control, as measured by HbA1c, combined with the percentage of patients with at least one treatment-emergent hypoglycemic episode. Patients will be treated with study therapy for approximately 26 weeks.
 +
|align = "center"|3
 +
|align = "center"|Feb-07
 +
|-
 +
|align = "justify"|[http://clinicaltrials.gov/ct/show/NCT00451113?order=1 Sitigliptin]
 +
|align = "justify"|Merck Frosst Canada Ltd, University of British Columbia
 +
|align = "justify"|
 +
|align = "center"|2
 +
|align = "center"|Nov-06
 +
|-
 +
|align = "center" colspan = "5"|<font color="#FF0000">'''Antibodies'''</font>
 +
|-
 +
|align = "justify"|[http://clinicaltrials.gov/ct/show/NCT00129259?order=1 hOKT3gamma1 (Ala-Ala)]
 +
|align = "justify"|NIAID
 +
|align = "justify"|hOKT3gamma1 (Ala-Ala) is a man-made antibody that is commonly used to prevent organ rejection. The purpose of this study is determine whether hOKT3gamma1 (Ala-Ala) can halt the progression of newly diagnosed type 1 diabetes.
 +
|align = "center"|2
 +
|align = "center"|Sep-05
 +
|-
 +
|align = "justify"|[http://clinicaltrials.gov/ct/show/NCT00279305?order=1 Anti-CD20 (rituximab)]
 +
|align = "justify"|NIDDK, NICHD, NIAID, NICR, ADA, JDRF
 +
|align = "justify"|This study will investigate the use of rituximab to see if it can help lower the number of immune B cells thereby preventing the destruction of any remaining insulin producing beta cells that remain at diagnosis.
 +
|align = "center"|2, 3
 +
|align = "center"|Dec-06
 +
|-
 +
|align = "center" colspan = "5"|<font color="#FF0000"><font size = "4">'''Surgical'''</font></font>
 +
|-
 +
|align = "justify"|[http://clinicaltrials.gov/ct/show/NCT00303134?order=1 Islet Cell Transplants]
 +
|align = "justify"|Weill Medical College of Cornell University
 +
|align = "justify"|
 +
|align = "center"|1
 +
|align = "center"|Aug-03
 +
|-
 +
|}
 +
 
 +
==Conferences==
 +
* [http://www.keystonesymposia.org/Meetings/ViewMeetings.cfm?MeetingID=922 Diabetes Mellitus, Insulin Action and Resistance] at Breckenridge, Colorado from January 22 - 27, 2008
 +
* [http://www.diabetes.org.uk/Professionals/Conferences_and_events/Annual-Professional-Conference-2008/ Diabetes UK Annual Professional Conference 2008] at Glasgow from 05 Mar 2008 09:00 to 07 Mar 2008 17:00
 +
* [http://www.conferencealerts.com/seeconf.mv?q=ca13a3h0 7th International Diabetes Federation Western Pacific Region Congress] at  Wellington, New Zealand on 30 Mar 2008.
 +
* [http://debussy.hon.ch/cgi-bin/confevent?aff2+CONF07692+Diabetes_Mellitus 1st International Conference on Advanced Technologies & Treatments for Diabetes] at Czech Republic during 27 Feb to 01 Mar 2008.
 +
* [http://www.goingtomeet.com/conventions/details/5301 Discovery Strategies Conference: Modeling Human Metabolic Syndrome and Type 2 Diabetes in Rodents] at Us during Aug-05-2007.
 +
* [http://www.goingtomeet.com/conventions/details/15113 7th International Conference for Clinical Endocrinology,Diabetes and Infertility] at Egypt during Sep-06-2007.
 +
* [http://www.diabetes.ca/section_professionals/confindex.asp CDA/CSEM Professional Conference and Annual Meetings] at British Columbia during October 24-27, 2007.
 +
 
 +
===Conference Update: [http://www.diabetes.org/home.jsp American Diabetic Association 2007] ===
 +
==== Conference highlights for Oral Hypoglycemic Agents ====
 +
 
 +
# [[Oral_Diabetes_Drugs#Products:_Oral_Hypoglycemic_Agents|Oral hypoglecemic agents]] and their role in diabetes treatment. The focus was the recent meta analysis published in [http://content.nejm.org/cgi/content/full/356/24/2457?ijkey=9288cc5edfcb35c1e7f1bd5d974d1169d64cea0b NEJM], showing increase CV mortality with Rosiglitazone. The panel consensus was that while awaiting more safety data, for now those patients who are tolerating Rosiglitazone should continue taking them, whereas newly diagnosed patients should try alternative treatment. Also all PPAR agonists should be treated as distinct entities rather than having class effect.
 +
# 12 different [[Oral_Diabetes_Drugs#Products:_Oral_Hypoglycemic_Agents| diabetes products]] are in various stages of development, and there were about 55 abstracts talking about DPP–IV inhibitors. They are especially useful for:
 +
#* The elderly
 +
#* Those with renal insufficiency
 +
#* Heart failure patients
 +
#[http://www.amylin.com/pipeline/symlin.cfm Amyline] analogue (Pramlinitide) was combined with Insulin for treatment of Type 2 DM and results were favorable.
 +
# Continuous glucose monitoring using implanted glucose sensors is a step forward in evolving technology. Yet it is still very expensive and best for highly trained patients on intensive insulin therapy.

Revision as of 23:40, 11 September 2007

Diabetes is a disease caused by high levels of blood glucose resulting from improper production of insulin or action of insulin.

  • Type 1: In this Diabetes, the cells that make the hormone insulin regulate the blood glucose are destroyed by the body immune system. This is also called as juvenile onset diabetes as it occurs mainly in children and young adults. 5%-10% of all the cases of diabetes have Type I diabetes. Clinical trials are being pursued and planned to prevent type I diabetes. This is also called as Insulin Dependent Diabetes Mellitus (IDDM).
  • Type 2: In this case, either the cells do not use insulin properly or the body does not produce enough insulin. 90% - 95% of the diabetics have Type 2 diabetes. This type of disease is also called as non-insulin dependent diabetes mellitus (NIDDM) and is mainly observed in people with old age, obese, family history of diabetes, history of gestational diabetes, impaired glucose metabolism, physical inactivity and race/ethnicity.
  • Gestational Diabetes: Increase in the levels of blood sugar during pregnancy is called gestational diabetes.

Incidence and prevalence

Incidence

In year 2004, diabetes ( Both type I and type II ) was diagnosed in 1.4 million adults between the age of 18-79 years (Figure 1). The incidence of diabetes was lower in adults having an age between 18-44 years compared to other groups (Figure 2). From 1997 through 2004, the age adjusted incidence of diagnosed diabetes ( Both type I and type II )increased by 35% among men and 46% among women (Figure 3).

Figure 1. Annual number (in thousands) of new cases of diagnosed diabetes among adults aged 18-79 years, in United States from 1997-2004. Source
Figure 3. Gender based incidence of diagnosed diabetes per 1000 population aged from 18-79 years in U.S. Source
Figure 2. Incidence of diagnosed diabetes per 1000 population aged 18-79 years, by age in U.S from 1997 to 2004. Source
.
S.NO Country/Region Extrapolated incidence
1 USA 861,533
2 Canada 95,372
3 Europe 1,474,002
4 Asia 10,063,645
5 Africa 1,290,255
6 Middle east 1,055,809
7 Australia and Southern Pacific 70,138

Prevalence

The prevalence of diabetes( Both type I and type II ) in U.S. during the years 1980 to 2005, increased from 5.6 million to 15.8 million (Figure 4). Especially people aged from 65 to 74 had the highest prevalence compared to other age groups (Figure 5). The prevalence of the disease was similar in both men and women till the year 1998 but from 1999, the prevalence of the disease increased highly in men compared to females (Figure 6).

Figure 4. Number (millions) of persons with diagnosed diabetes from year 1980 to 2005 in United States. Source
Figure 5. Age dependent Prevalence of diagnosed diabetes in United States from year 1980 to 2005. Source
Figure 6. Gender dependent Prevalence of diagnosed diabetes in United States from year 1980 to 2005. Source
.
S.NO Country/Region Extrapolated Prevalence
1 USA 17,273,847
2 Canada 1,912,227
3 Europe 33,882,009
4 Asia 201,777,550
5 Africa 25,393,535
6 Middle east 21,169,243
7 Australia and Southern Pacific 1,406,291

Market Overview

  • The Insulin market in 2006 was largely dominated by two players, Novo Nordisk of Denmark and Eli Lilly of USA.
  • India and China are emerging as the most potential future markets for insulin delivery devices.
  • Growing at a CAGR of 14.09%, global insulin market will reach US$ 14.5 Billion by 2010 from US$ 7.5 Billion in 2005.
  • Over 60% of the insulin sold in 2006 was sold in pen devices.
  • Insulin pen devices dominate the market in Europe and Japan whereas syringes and pumps dominate the US market.
  • There was a big improvement in the global diabetes market for innovation particularly in the field of non-invasive methods of insulin delivery, including inhalable, oral and patch technology. Source
  • There are 3 key new OAD classes; PPAR agonists, GLP-1 agonists/DPP IV inhibitors, and amlinomimetic agents. High forecasted sales are anticipated in 2011 for the GLP-1 agonist Exenatide LAR and the DPP-IV inhibitor Galvus at $2,902.9m and $1,228.7m, respectively. Source
Diabetic market data.jpeg

A. Competitive dynamics of the leading players in the global diabetes market, 2005 B. Global diabetes market share by geography, 2005] C. Worldwide Diabetes Market, 2000, 2001, 2002 and 2007 D. Global* market share of leading insulins (%), 1999-2003

Product Information

Overall categorization of diabetes treatments

Products: Oral Hypoglycemic Agents

Oral Hypoglycemic Agents
Drug Brand Company Availability
Sulfonylureas
First Generation      
Acetohexomide Dymelor Eli Lilly US, F, G, I, S,UK, J
Chlorpropamide, Tolazamide Diabenase Pfizer US, F, G, I, S,UK, J
Second Generation      
Glyburide (Glibenclamide) Diabeta Aventis US, F, G, I, S,UK, J
Glyburide (Glibenclamide) Micronase Pharmacia US, F, G, I, S,UK, J
Glyburide (Glibenclamide) Glynase Pharmacia US, F, G, I, S,UK, J
Glypizide Glucotrol, Glucotrol XL Pfizer US, F, G, I, S,UK, J
Third Generation      
Glimepride Amaryl Aventis US, F, G, I, S,UK, J
Meglitnides
Repaglinide Prandin Novo Nordisk US, F, G, I, S,UK, J
Nateglinide Sralix Novartis US,UK, J
Biguanides
Metfromin Glucophage, Glucophage XR Bristol-Myers Squibb US
Metfromin      
Thiazolidinediones
Rosiglitazone Avandia Glaxosmithkline US, G, UK
Pioglitazone Actos Takeda/ Eli Lilly US, UK, G, S, J
Alfa-Glucosidase Inhibitors
Acarbose Precose Bayer US, F, G, I, S,UK, J
Miglitol Glyset Pharmacia US, F, G, S
Voglibose Basen, Volix, Vogseal Ranbaxy, Nihon Pharmaceutical Industry Ltd I, J
Dipeptidyl peptidase-4 (DPP-4) inhibitor
Sitgliptin Januvia Merck US

Products: Fixed Drug Combinations

Fixed Drug Combinations
Brand Name Drug 1 Drug 2 Company
Metaglip Glipizide Metformin Bristol-Myers Squibb
Duetact Glimepiride Pioglitazone Takeda
Avandaryl Glimepiride Rosiglitazone GlaxoSmithKline
ACTOSPlusMet Pioglitazone Metformin Takeda
Avandamet Rosiglitazone Metformin GlaxoSmithKline
Janumet Sitgliptin Metformin Merck

Product pipeline

Product Pipeline
Drug Company Stage
Dipeptidyl Peptidase IV (DPP-IV) Inhibitor :DPP-IV inactivates glucagon-like peptide-1 (GLP-1), an important mediator of blood glucose levels following meals. DPP-IV inhibitors have been clinically shown to provide long term improvement of glucose control without the risk of hypoglycemia, and to improve the function of pancreatic beta cells, the cells responsible for the production of insulin.
ALS 2-0426 Alantos Pharmaceuticals, Amgen, Servier 1
PSN9301 OSI 2
SYR-322 Takeda 3
R1579 Roche 1
vildagliptin (Galvus) novartis NDA submitted in March 2006
MP-513 Mitsubishi Pharma 2
Gastrin + DPP IV Inhibitor Transition Therapeutics 2
Saxagliptin Otsuka Pharmaceutical Co, Bristol-Myers Squibb 3
Insulin sensitizer
MBX 102 Metabolex 2
MBX-2044 Metabolex 1
ISIS 113715 Isis 3
NCX 4016 NicOx 2
Cholebine Mitsubishi Pharma 2
DG070 inhibitors Develogen AG Preclinical
NovoNorm®/Metformin Novo Nordisk 3
GLP 1 Analogue / Agonists
TH0318 Theratechnolgies 1
Liraglutide (NN2211) Novo Nordisk 3
R1583 Roche 2
Oral GLP Emisphere Technologies 1
PC-DAC™:Exendin-4 ConjuChem 2
  Bristol-Myers Squibb Exploratory development
AVE0001A Sanofi Aventis 2
Gastrin +GLP 1 Agonist Transition Therapeutics 2
Peroxisome Proliferator-Activated Receptor (PPAR) agonist/analogue
AVE8134 Sanofi Aventis 2
AVE0897 Sanofi Aventis 1
R1439, aleglitazar Roche 2
AVE0847 Sanofi Aventis 2
SAR351034 Sanofi Aventis Preclinical
376501 Glaxosmithkline 1
625019 Glaxosmithkline 1
677954 Glaxosmithkline 2
Avandia Glaxosmithkline 2
Avandia XR Glaxosmithkline 2
PPAR Gamma Agonist + simvaststin Glaxosmithkline 3
MCC-555, Netoglitazone Mitsubishi Pharma, Novartis  
Muraglitzar Bristol-Myers Squibb 3
Oral glucokinase activator (GKA)
PSN010 OSI 1
R1511 Roche 1
G protein-coupled Receptor(GPR) 119 Agonist
PSN821 OSI  
β3-Adrenergic Receptor Agonist
Solabegron (GW427353) Glaxosmithkline 1
Antisense drug for Glucagon Receptor (GCGR)
ISIS 325568 Isis 1
ISIS 377131 Isis Preclinical
Sodium Glucose Transporter 2 (SGLT2) inhibitor
AVE2268 Sanofi Aventis 2
SAR 7226 Sanofi Aventis Preclinical
189075 Glaxosmithkline 2
N-methyl-D-aspartic acid (NMDA) receptor antagonist
Perzinfotel Wyeth 2
Growth hormone releasing analogue
TH 9507 Theratechnolgies  
Aldolase reductase inhibitor
SNK-860, fidarestat Sankyo 3
Neurotrophin Enhancer
MCC-257 Mitsubishi Pharma 2
Nitric oxide (NO) blocking agent
NOX-700 Medinox 1 staretd in 2002
Antibody
TRX4 BTG 2
11-beta hydroxysteroid dehydrogenase type 1 (11ß-HSD1) inhibitor
AMG 221 Amgen 1
Polypyrimidine tract binding protein (PTB, also named hnRNP) inhibitor
  Serono 1
Insulin Like Growth Factor 1
IPLEX Glen Allen Orphan Drug Status
Miscellaneous
  Metabolex 1
MBX-8025 Metabolex 2
Nateglinide with insulin sensitizers Astellas pharmas SNDA Filed
Nateglinide with biguanides Astellas pharmas SNDA Filed
     
869682 Glaxosmithkline 2
815541 Glaxosmithkline 1
625019 Glaxosmithkline 1
189075 Glaxosmithkline 1
677954 Glaxosmithkline 2
PPM-204 Wyeth 2
CS-011 (Roviglitazone) Sankyo 2
ACOMPLIA®( Rimonabant*) Sanofi Aventis 3
CS-917 Sankyo 2
R 1499 Roche 1
R1438 Roche 2
R483 Roche 2
R1440 Roche 2
PSN 357 OSI 1
NBI 6024 Neurocrine Biosciences 2
CS-917 metabasis, Daiichi Sankyo 2
MB07803 metabasis, Daiichi Sankyo 2
AMPK Project metabasis, Daiichi Sankyo Discovery
MK 0941 Merck 1
MK 1642 Merck 1
Mk 0533 Merck 2
MK0893 Merck 2
Arxxant (ruboxistaurin) Eli Lilly 3
11 B- HSD 1 Biovitrum, Amgen 1
Gastrin + Metformin Transition Therapeutics 1
AMG 837 Amgen 1
Darbepoetin alfa Amgen 3
Smylin(Amylin analogue) Amylin 4
Exenatide LAR Amylin 2
DG770 (beta cell regeneration factor) Develogen AG 3
E1 INT (Islet regeneration) Transition Therapeutics 2
Mecasermin rinfabate (IPLEX) (IGF 1 and 2) Insmed Approved in 2005
Orlistat (Xenical) (Lipase inhibitor) Roche  
Insulins
Oral Insulin Emisphere Technologies 2
Technosphere Mannkind corporation 3
NN344 (Insulin analogue) Novo Nordisk 1
NN5401(Insulin analogue) Novo Nordisk 1
AERx® iDMS (Insulin Inhalation system) Novo Nordisk 3
Inhaled insulin Bristol Meyers Squibb 1
Inhaled insulin Eli Lilly 2
Exubera (Inhaled insulin) Pfizer 4
Oal Lyn (Inhaled insulin) http://www.generex.com/products/oral-lyn/ Approved in Ecuador
Nasulin Bentley 2

Intellectual Property

Search strategy

  • Database/Vendor: Micropat
  • Search scope: US Granted US Applications EP-A EP-B WO JP (bibliographic data only) DE-C,B DE-A DE-T DE-U GB-A FR-A; English Title
  • Years: Issue/Publication Date: >20051231
  • String: (Diabetes OR diabetic) AND (treatment OR treating)
  • Hits: 618/217 patents (with/with out family members)
  • Date of search: 11 July 2007

Top players and IPC classes

Diabetes- top players.jpeg

IPC code definition

A61K Preparations for medical, dental, or toilet purposes
C07D Heterocyclic compounds
C07K Peptides
C12N Micro-organisms or enzymes; compositions thereof
C12Q Measuring or testing processes involving enzymes or micro-organisms (immunoassay); compositions or test papers therefor; processes of preparing such compositions; condition-responsive control in microbiological or enzymological processes

Geographical Distribution and Treatment Approaches

Diabetes -geographical.jpeg

IP activity and Treatment Approaches

Diabetes -year approach.jpeg

Clinical Trials

Approved/On-going

Clinical trials
Drug Sponsors Description Phase Date of Start
Oral Drugs
Cannabinoid receptor antagonist
Rimonabant Sanofi-Aventis The primary objective of this study is to assess the efficacy of SR141716 (rimonabant) compared to placebo on change in HbA1c and on relative change in body weight over 52 weeks in obese type 2 diabetic patients on monotherapy inadequately controlled with oral anti-diabetic drug (sulfonylurea or ?-glucosidase inhibitor). 3 May-07
Insulin Sensitisers
Metaglidasen Metabolex 2, 3 May-06
Thioglitazone
Rosiglitazone maleate/metformin hydrochloride (AVANDAMET) GlaxoSmithKline This study will evaluate the longer-term glycemic effect of two medicines approved for initial treatment of type 2 diabetes. 4 Oct-06
Balaglitazone Rheoscience A/S Balaglitazone is a thiazolidinedione derivative that is being developed as an oral anti-diabetic drug to improve blood glucose control in patients with type 2 diabetes. The purpose of this study is to assess if additional treatment with balaglitazone in patients with type 2 diabetes on stable insulin treatment will improve blood glucose control and decrease the daily insulin dose, but with less impact on weight gain and oedema. 3 Jul-07
(DPP-4) inhibitor
Vildagliptin Novartis This is a 24-week study to assess the efficacy on HbA1c of 100 mg vildagliptin once daily as compared to placebo as add-on to metformin in patients with type 2 diabetes inadequately controllled with metformin. 3 May-06
Insulin
Oral Insulin NIDDK, NICHD, NIAID, NICR, ADA, JDRF N/A 3 Feb-07
Potassium Channel Blocker
Diazoxide Grill, Valdemar, M.D. The purpose of this study is to find out if Diazoxide can partly retain insulin production in newly diagnosed type 1 diabetes patients. 4 Feb-05
Nutritional Agents
Benfotiamine (Vitamin B1) University Hospital, Aker, The Research Council of Norway N/A 1, 2 Aug-05
Docosahexaenoic acid (DHA) NIDDK N/A 2 June 2006
Vitamin D University of Tromso The purpose of the study is to evaluate if supplementation with vitamin D in a dose of 40.000 IU per week will result in improved metablic control in patients with type 2 diabetes. 2 Jun-06
Carnitine Supplementation Children’s Mercy Hospital Kansas City,Sigma Tau Pharmaceuticals, Inc, Minimed Pharmaceuticals, Pharmacia/Upjohn Career Development Award The purpose of this study is to determine whether type I diabetics with carnitine deficiency exhibit increased numbers of hypoglycemic (low blood sugars) events and if unrecognized hypoglycemia occurs during continuous 72-hour glucose monitoring. If they are determined to have unrecognized hypoglycemia, then oral carnitine supplementation will be given to those subjects and they will be reassessed for the number of hypoglycemic events in a 72-hour glucose monitoring. Oct-04
Antiinflammatory
Salsalate NIDDK,National Institutes of Health Clinical Center This study, conducted at the Phoenix Indian Medical Center, Phoenix, Arizona, will determine whether reducing subclinical inflammation lessens insulin resistance in healthy, obese volunteers. 4 Mar-03
Angiotensin (AT 2) Antagonist/blocker
Olmesartan Daiichi Sankyo Inc N/A 3 Oct-04
MBX-2044 Metabolex The purpose of this study is to collect important information regarding the glucose-lowering efficacy of MBX-2044 and the safety of MBX-2044 (especially weight gain and edema) in diabetics. It will also provide important information about the appropriate doses to be used in subsequent longer-term studies to evaluate the safety and efficacy of MBX-2044 alone and in combination with other anti-diabetic agents. 2 Oct-06
PF-00734200 Pfizer The purpose of this Phase 2a study is to evaluate the efficacy, safety and tolerability, of multiple parallel doses of PF-00734200 following oral administration to adult human subjects with T2DM who currently are on a stable dose of metformin. 2 Jun-07
CP-945,598 Pfizer The purpose of this study is to determine if CP-945,598 is effective in the treatment of obesity in type 2 diabetic patients 3 Nov-06
WelChol® (colesevelam) Daiichi Sankyo Inc This study is designed to assess the potential mechanism of action by which WelChol® (colesevelam) may improve blood glucose control in patients with type 2 diabetes 2 May-05
Aleglitazar and Actos® Hoffmann-La Roche This study will compare the effects of aleglitazar and Actos®, added to preexisting oral antihyperglycemic therapy and/or diet and exercise, on renal function in patients with type 2 diabetes, and normal or mildly impaired renal function. 2 June 2007
BI 1356 BS Boehringer Ingelheim Pharmaceuticals The objective of this monotherapy study is to investigate the efficacy, safety, and tolerability of 3 doses of BI 1356 BS compared to placebo over 12 weeks of treatment in patients with type 2 diabetes and insufficient control of thier blood glucose. In addition, there will be an open-label treatment arm with metformin. The hypothesis of the trial is that the test drug, BI 1356 BS will lead to better control of blood glucose compared to placebo after 12 weeks of treatment. 2 May-06
BMS-512148 Bristol-Myers Squibb The purpose of this clinical research study is to learn if BMS-512148, added to insulin and one or two anti-diabetes medications (metformin and/or pioglitazone or rosiglitazone), can help reduce the blood sugar levels compared to insulin and one or two anti-diabetes medications (metformin and/or pioglitazone or rosiglitazone) alone, in subjects with type 2 diabetes. 2, 3 October 2006
Parenteral routes
Insulins
Insuline glargine Sanofi-Aventis Purpose ogf this study is to determine rhe first dose and titration of basal insulin 4 May-06
Basal Insulin Plus Insulin Glulisine Sanofi-Aventis To evaluate the efficacy of a single injection of glulisine before the main meal added to insulin glargine plus oral antidiabetic drugs (OADs) compared to insulin glargine plus OADs in Type 2 diabetic patients poorly controlled with basal insulin plus OADs. 4 Jul-06
Inhaled Insulin (Exubera) Pfizer To assess the impact on glucose control by inhaled insulin in patients with type 2 diabetes who are not well controlled on 2 or more oral anti-diabetic agents 3 Mar-06
Insulin Inhalation Powder Eli Lilly and Company This is a phase 3, open-label, randomized study to evaluate the safety and efficacy of the Lilly/Alkermes inhaled insulin system compared to injected pre-meal insulin in non-smoking patients with type 2 diabetes. Patients will be treated for 24 months with a 2-month follow-up period. 3 Apr-06
Levemir Novo Nordisk This trial aims for a comparison of the effect on glycaemic control in subjects with type 2 diabetes under both established Western algorithm and Korean practical algorithm, given in combination with oral diabetic drug(s) 4 Aug-07
Pulsatile IV Insulin Florida Atlantic University The purpose of this study is to determine if restoring normal metabolic function in patients with either type I or type II diabetes can improve the impact of the consequences of diabetic complications on the overall quality of life of diabetic patients. Patients are treated once a week with pulsatile intravenous insulin therapy mimicking normal insulin secretion. 2, 3 Mar-03
Incretin Minetic
Exenatide With Basal Insulin Amylin Pharmaceuticals, Eli Lilly This is a phase 3 trial designed to compare the effects of twice daily exenatide plus oral antidiabetic agents (OADs) and once-daily insulin glargine plus OADs with respect to glycemic control, as measured by hemoglobin A1c, with minimum weight gain, in patients with uncontrolled type 2 diabetes on OADs. 3 Jun-06
Exenatide Baylor College of Medicine, NIH The purpose of this study is to see if giving exenatide and insulin before a meal would lower blood sugars after the meal. 4 Mar-07
Exenatide Plus Metformin vs. Insulin Aspart Plus Metformin Amylin Pharmaceuticals, Eli Lilly This study in Germany is designed to compare the effects of twice-daily exenatide plus metformin and twice-daily premixed human insulin aspart plus metformin with respect to glycemic control, as measured by HbA1c, combined with the percentage of patients with at least one treatment-emergent hypoglycemic episode. Patients will be treated with study therapy for approximately 26 weeks. 3 Feb-07
Sitigliptin Merck Frosst Canada Ltd, University of British Columbia 2 Nov-06
Antibodies
hOKT3gamma1 (Ala-Ala) NIAID hOKT3gamma1 (Ala-Ala) is a man-made antibody that is commonly used to prevent organ rejection. The purpose of this study is determine whether hOKT3gamma1 (Ala-Ala) can halt the progression of newly diagnosed type 1 diabetes. 2 Sep-05
Anti-CD20 (rituximab) NIDDK, NICHD, NIAID, NICR, ADA, JDRF This study will investigate the use of rituximab to see if it can help lower the number of immune B cells thereby preventing the destruction of any remaining insulin producing beta cells that remain at diagnosis. 2, 3 Dec-06
Surgical
Islet Cell Transplants Weill Medical College of Cornell University 1 Aug-03

Conferences

Conference Update: American Diabetic Association 2007

Conference highlights for Oral Hypoglycemic Agents

  1. Oral hypoglecemic agents and their role in diabetes treatment. The focus was the recent meta analysis published in NEJM, showing increase CV mortality with Rosiglitazone. The panel consensus was that while awaiting more safety data, for now those patients who are tolerating Rosiglitazone should continue taking them, whereas newly diagnosed patients should try alternative treatment. Also all PPAR agonists should be treated as distinct entities rather than having class effect.
  2. 12 different diabetes products are in various stages of development, and there were about 55 abstracts talking about DPP–IV inhibitors. They are especially useful for:
    • The elderly
    • Those with renal insufficiency
    • Heart failure patients
  3. Amyline analogue (Pramlinitide) was combined with Insulin for treatment of Type 2 DM and results were favorable.
  4. Continuous glucose monitoring using implanted glucose sensors is a step forward in evolving technology. Yet it is still very expensive and best for highly trained patients on intensive insulin therapy.
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