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Diabetes 2
Diabetes 2
Diabetes 2
Diabetes 2
Diabetes 2
Diabetes 2
Diabetes 2
Diabetes 2
Diabetes 2
Diabetes 2
Diabetes 2
Diabetes 2
Diabetes 2
Diabetes 2
Diabetes 2
Diabetes 2
Diabetes 2
Diabetes 2
Diabetes 2
Diabetes 2
Diabetes 2
Diabetes 2
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Diabetes 2

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  • 1. Atreyi Banerjee Pipeline products in Phase III
  • 2.
    • Introduction
    • Major mechanism of action
    • End points employed in clinical trials
    • Duration of trials
    • Route of administration
    Outline
  • 3. Diabetes
    • Diabetes is a chronic disease that occurs either when the pancreas does not produce enough insulin or when the body cannot effectively use the insulin it produces. Insulin is a hormone that regulates blood sugar. Hyperglycaemia, or raised blood sugar, is a common effect of uncontrolled diabetes and over time leads to serious damage to many of the body's systems, especially the nerves and blood vessels.
      • Type 1 Diabetes (previously known as insulin-dependent, juvenile or childhood-onset) is characterized by deficient insulin production and requires daily administration of insulin.
      • Type 2 Diabetes (formerly called non-insulin-dependent or adult-onset) results from the body’s ineffective use of insulin. Type 2 diabetes comprises 90% of people with diabetes around the world, and is largely the result of excess body weight and physical inactivity.
      • Gestational Diabetes is hyperglycaemia with onset or first recognition during pregnancy.
  • 4. Epidemiology of Diabetes
    • An estimated 285 million people, corresponding to 6.4% of the world's adult population, will live with diabetes in 2010. The number is expected to grow to 438 million by 2030, corresponding to 7.8% of the adult population.
    • The prevalence of diabetes is higher in men than women, but there are more women with diabetes than men.
    • While the global prevalence of diabetes is 6.4%, the prevalence varies from 10.2% in the Western Pacific to 3.8% in the African region. However, the African region is expected to experience the highest increase.
    • The number of deaths attributable to diabetes in 2010 shows a 5.5% increase over the estimates for the year 2007. This increase is largely due to a 29% increase in the number of deaths due to diabetes in the North America & Caribbean Region, a 12% increase in the South East Asia Region and an 11% increase in the Western Pacific Region.
    • Almost 80% of diabetes deaths occur in low- and middle-income countries.
    • WHO projects that diabetes deaths will double between 2005 and 2030.
    • 50% of all diabetics are unaware of their condition.
    • The vast majority of people with type 2 diabetes suffer from a range of co-morbidities, such as obesity, hypertension and dyslipidaemia.
  • 5. Major marketed products in the Type-2 diabetes market
    • Actos (pioglitazone) ‏ Takeda
    • Avandia (rosiglitazone) GlaxoSmithKline
    • Januvia (sitagliptin) ‏ Merck & Co., Inc.
    • Starlix (nateglinide) ‏ Novartis
    • Byetta (exenatide) ‏ Amylin Pharmaceuticals, Inc. and Lilly USA, LLC.
    • Lantus (insulin glargine) ‏ Sanofi Aventis
    • Levemir (insulin detemir) ‏ Novo Nordisk
  • 6. Primary drugs candidates undergoing phase III clinical trial for Type -2 diabetes
    • BMS-512148 (dapagliflozin)
    • Victoza
    • D-Tagatose
    • JNJ-28431754 (canagliflozin) ‏
    • Albiglutide
      • According to New Pharmaceuticals research report from GlobalData 2010
  • 7. Five major drugs under phase III clinical trial for Type-2 diabetes
  • 8.
    • Sodium Glucose Co-transporter (SGLT2 inhibitor) ‏
    • Responsible for at least 90% of the glucose reabsorption in the kidney.
    • Subsides as blood glucose concentrations decrease and approach euglycemia
    • Oral dosage
    • Glycemic control, trend to weight loss
    BMS- 512148 (dapagliflozin) ‏
  • 9.
    • Analog of human GLP-1 and acts as a GLP-1 receptor agonist.
    • Liraglutide increases intracellular cyclic AMP (cAMP) leading to insulin release in the presence of elevated glucose concentrations.
    • Liraglutide also decreases glucagon secretion in a glucose-dependent manner.
    • The mechanism of blood glucose lowering also involves a delay in gastric emptying.
    • Glycemic control, trend to weight loss
    Victoza
      • Significant decrease in blood glucose levels as compared to those receiving metformin and rosiglitazone
  • 10.
    • In the GI tract, tagatose blocks the digestion of sucrose,maltose, and other carbohydrates
    • Slows absorption of glucose, and results in little or no spike in glucose after meals.
    • In the liver, Tagatose competitively blocks the enzyme that metabolizes glucose to be referentially stored as glycogen.
    • Oral dosage
    • Glycemic control determined by a statistically significant decrease in hemoglobin
    D-Tagatose
  • 11. JNJ-28431754 (canagliflozin) ‏
    • Sodium Glucose Co-transporter (SGLT2 inhibitor) ‏
    • Oral dosage
    • glycemic control,stable blood pressure, weight loss
    • But has some effect on renal function
  • 12.
    • GLP-1 (Glucagon-like peptide 1) agonist
    • DPPIV resistance and fusion to human albumin
    • Once-weekly or less frequent; subcutaneous injection using pen with small gauge needle
    • Demonstrated effective glycemic control, trend to weight loss, low incidence of GI side effects and low immunogenicity
    Albiglutide
      • Albiglutide is the only medication which fuses human GLP-1 to human albumin.  It is designed to have an extended duration of action and allow for weekly or less-frequent injections.
  • 13. Major mechanism of action under development
    • SGLT-2 inhibitors
    • Interleukin-1¦Â antagonists
    • CCR2 antagonists
    • GLP-1 agonists
    • DPP-IV Inhibitors
    • 11¦Â HSD inhibitors
    • Immune modulators
    • Antisense drugs targeting glucagon receptor
  • 14. End points employed in clinical trials
    • Survival
    • Completes response
    • Objective Response Rate
    • Progression Free Survival
    • Clinical benefit
    • Endpoints for selected drugs were HbA1c change from baseline and safety and tolerability with minimised or no adverse effects.
    • The secondary endpoints were change from baseline mean morning fasting body weight and renal glucose threshold maintenance.
  • 15. X X The average duration of study is 2 years and 6 months as calculated from www.clinicaltrials.gov Disease Progression Duration of trials Survival (X) ‏ X X X Censored
  • 16. Route of administration
    • Oral
      • Digestive tract (enteral)‏
      • Sublingual/ Sublabial
      • Respiratory tract
    • Parenteral
      • Subcutaneous Injection
      • e.g. Byetta (exenatide)‏
    • Surgical
      • Islet cell transplant predominantly Allogenic. The shortage of human donor pancreases for islet cell transplantation has led to a search for alternative sources of islet cells. Autologous is used to treat Type-1 patients when diabetes is not already present.
  • 17. WHO activities to prevent and control Diabetes
    • WHO aims to stimulate and support the adoption of effective measures for the surveillance, prevention and control of diabetes and its complications, particularly in low and middle-income countries. To this end, WHO:
      • provides scientific guidelines for diabetes prevention;
      • develops norms and standards for diabetes care;
      • builds awareness on the global epidemic of diabetes; including partnership with the International Diabetes Federation in the celebration of World Diabetes Day (14 November);
      • conducts surveillance of diabetes and its risk factors.
    • The WHO Global Strategy on Diet, Physical Activity and Health complements WHO's diabetes work by focusing on population-wide approaches to promote healthy diet and regular physical activity, thereby reducing the growing global problem of overweight and obesity.
  • 18. Overall categorization of diabetes treatments
  • 19. The key market players at present are Hoffmann-La Roche, Novo Nordisk, Merck & Co., Novartis Ag, Sanofi-aventis, Eli Lilly & Company and GlaxoSmithKline reinstated by the figure above. Competitive dynamics of the leading players in the global diabetes market, 2005
  • 20. Global* market share of leading insulins (%), 1999-2003 , The leading giant still is the US with more than 50% market share while the Pacific region is still growing owing to the large population of Diabetic patients in Japan and South Asia.
  • 21. Conclusion
    • The U.S. diabetes market has grown to more than $5 billion as the disease becomes more prevalent. Thus a rise in competitors.
    • Seven out of ten marketed diabetic drugs are oral proving that patients prefer oral administration of medicines.
    • The presently developed drugs have good toxicity profile which is very essential in today's market.
  • 22. References
    • www.clinicaltrials.gov
    • www.worlddiabetesfoundation.org
    • www.who.int/en/
    • www.gsk.com
    • www.globaldata.com/reportstore/
    • www.uchospitals.edu
    • www.msnbc.msn.com

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