BI10773 in T2D patients with renal impairment & poor glycaemic control

• Research type

  Research Study

• Full title

  A phase III, randomised, double-blind, placebo-controlled, parallel group, efficacy and safety study of BI 10773 (10 mg and 25 mg administered once daily) as add on to pre-existing antidiabetic therapy over 52 weeks in patients with type 2 diabetes mellitus and renal impairment and insufficient glycaemic control.

• IRAS ID

  51144

• Contact name

  Anthony Barnett

• Sponsor organisation

  Boehringer Ingelheim Ltd

• Eudract number

  2009-016179-31

• ISRCTN Number

  n/a

• 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 thenext 20 years, and the high frequency of complications leads to a significant reduction in life expectancy.Chronic kidney disease is a common condition in patients with type 2 diabetes. Renal impairment is a condition in which the kidneys do not function properly. Due to safety and tolerability issues, there are limited diabetes treatment options for patients with type 2 diabetes who have chronic kidney disease. This study is looking at the safety and effectiveness of BI10773 (10 mg and 25 mg/ once daily) as an add-on to pre-existing diabetes medication in patients with type 2 diabetes with insufficient glycaemic control and renal impairment. Patients will be randomly allocated to treatment with either BI10773 or placebo. Placebo is a dummy treatment which looks like the genuine medicine but contains no active ingredient.Treatment will last 52 weeks, during which time there will be 11 study visits. In the UK the study will be run at hospitals and GP practices.

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  10/H1208/43

• Date of REC Opinion

  25 Aug 2010

• REC opinion

  Further Information Favourable Opinion