Cardiovascular safety study of a new drug BI 10773 in Type 2 Diabetes

• Research type

  Research Study

• Full title

  A Phase III, multicentre, international, randomised, parallel group, double blind cardiovascular safety study of BI 10773 (10 mg and 25 mg administered orally once daily) compared to usual care in type 2 diabetes mellitus patients with increased cardiovascular risk.

• IRAS ID

  52300

• Contact name

  John McKnight

• Sponsor organisation

  Boehringer Ingelheim Ltd

• Eudract number

  2009-016178-33

• ISRCTN Number

  0

• Clinicaltrials.gov Identifier

  0

• Research summary

  Type 2 diabetes accounts for 90 to 95% of all cases of diabetes and is an increasingly prevalent disease with an estimated 180 million affected people worldwide. The incidence of type 2 diabetes is expected to double during the next 20 years, and the high frequency of complications leads to a significant reduction in life expectancy. This study is looking at the cardiovascular safety of BI10773, a drug which lowers blood glucose in patients with type 2 diabetes and at an increased risk of cardiovascular events. Patients will be randomly allocated to treatment with either BI10773 (10mg/daily or 25mg/daily) or placebo. Placebo is a dummy treatment which looks like the genuine medicine but contains no active ingredient. It is anticipated that trial duration will be 4 years (206 weeks), although the trial will stop once enough cardiovascular events have occurred. In the UK the study will be run in hospitals and at GP practices.

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  10/H1010/36

• Date of REC Opinion

  5 Aug 2010

• REC opinion

  Further Information Favourable Opinion