BI10773 add on to basal insulin in T2D

• Research type

  Research Study

• Full title

  A phase IIb, randomised, double-blind, placebo-controlled, parallel group, safety and efficacy study of BI 10773 (10 mg and 25 mg) administered orally, once daily over 78 weeks in type 2 diabetic patients receiving treatment with basal insulin (glargine, detemir, or NPH insulin only) with or without concomitant metformin and / or sulfonylurea therapy and insufficient glycaemic control

• IRAS ID

  22154

• Contact name

  John Reckless

• Eudract number

  2009-013668-38

• ISRCTN Number

  Not applicable

• 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 safety and effectiveness of BI10773 in patients with type 2 diabetes, who are already receiving treatment with basal insulin with or without concomitant metformin and / or sulfonylurea. 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 78 weeks, during which time there will be 12 study visits. In the UK the study will be run at hospitals and GP practices.

• REC name

  South West - Cornwall & Plymouth Research Ethics Committee

• REC reference

  09/H0206/53

• Date of REC Opinion

  4 Nov 2009

• REC opinion

  Further Information Favourable Opinion