BI10773 in T2D patients in comparison to Glimepiride

• Research type

  Research Study

• Full title

  A phase III randomised, double-blind, active-controlled parallel group efficacy and safety study of BI 10773 compared to glimepiride administered orally during 104 weeks in patients with type 2 diabetes mellitus and insufficient glycaemic control despite metformin treatment

• IRAS ID

  56685

• Contact name

  Richard Gaunt

• Sponsor organisation

  Boehringer Ingelheim Ltd

• Eudract number

  2009-016244-39

• ISRCTN Number

  0000000000000

• Clinicaltrials.gov Identifier

  0000000000000

• 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.This study is looking at the safety and Effectiveness of BI10773 (25 mg/once daily) as an add-on to metformin therapy in patients with type 2 diabetes with insufficient glycaemic control in comparison to Glimiperide. patients will be randomly allocated to treatment with either BI10773 or Glimepiride.Treatment will last 104 weeks, during which time there will be 15 study visits. In the UK the study will be run at GP practices.

• REC name

  Wales REC 3

• REC reference

  10/MRE09/21

• Date of REC Opinion

  21 Jul 2010

• REC opinion

  Favourable Opinion