BC21893 TASPOGLUTIDE VS PIOGLITAZONE AS ADD-ON TO SU OR METFORMIN+SU

• Research type

  Research Study

• Full title

  BC21893 - A multicentre, randomised, double blind (double dummy), active-comparator controlled study to compare the efficacy, safety and tolerability of taspoglutide versus pioglitazone in type 2 diabetes patients inadequately controlled with sulphonylurea (SU) monotherapy or metformin plus sulphonylurea combination therapy.

• IRAS ID

  18507

• Sponsor organisation

  Roche Products Ltd

• Eudract number

  2009-009157-24

• 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's 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. There are currently over 2.5 million people with diabetes in the UK and there are more than half a million people with diabetes who have the condition without realising it. Lifestyle trends are leading to increasing obesity and together with a rising age in population, the prevalence of diabetes is likely to increase.In recent years there have been major advances in the treatment of type 2 diabetes - new drugs have provided higher levels of effectiveness in many patients, while the early diagnosis and treatment of the disease have also improved outcomes. However, despite these advances, 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. Data from 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. We hope to learn from this study how effective taspoglutide is when given as a once weekly injection, compared to pioglitazone (currently marketed drug) when given once daily, in patients treated with a sulphonylurea.

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  09/H0406/62

• Date of REC Opinion

  5 Jun 2009

• REC opinion

  Further Information Favourable Opinion