BC22092 Taspoglutide vs placebo in obese patients with Type 2 diabetes

• Research type

  Research Study

• Full title

  BC22092 A multicentre, randomised, double-blind, placebo-controlled study to assess the efficacy, safety and tolerability of taspoglutide (R05073031) compared to placebo in obese patients with type 2 diabetes mellitus inadequately controlled with metformin monotherapy.

• IRAS ID

  9768

• Contact name

  Carol McKinnon

• Sponsor organisation

  Roche Products Ltd

• Eudract number

  2008-005809-20

• ISRCTN Number

  NA

• Research summary

  Type 2 diabetes develops when the body can still make some insulin, but not enough, or when the insulin that is produced does not work properly. In most cases this is linked with being overweight. Type 2 diabetes usually appears in people over the age of 35. Drugs currently available are often inefficient in achieving glycaemic control, mainly because they address only one of several underlying defects. Many patients either do not receive an adequate response or cannot tolerate these new drugs. Therefore new treatments are needed especially if they can be aimed at different underlying defects. Treatment with taspoglutide or other GLP-1 analogues represent a new approach to the treatment of diabetes. Taspoglutide is an investigational drug that could help to control glucose levels in the blood of patients with Type 2 diabetes. We hope to learn from this study how effective taspoglutide is in obese patients when given once weekly compared to a placebo.The purpose of this study is to learn how effective taspoglutide is, when given once weekly compared to a placebo. Previous Taspoglutide studies have shown that in patients with Type 2 diabetes this drug is both safe and effective. The results showed that taspoglutide achieved reductions in glycaemic control (lower blood sugar) and body weight. The study will recruit obese diabetic patients aged 18-75 years currently receiving Metformin. The study will last for 52 weeks.

• REC name

  East of England - Cambridge South Research Ethics Committee

• REC reference

  08/H0305/79

• Date of REC Opinion

  14 Jan 2009

• REC opinion

  Further Information Favourable Opinion