BI 1356 Open Label Extension Study in Patients with Type 2 Diabetes

• Research type

  Research Study

• Full title

  A 78 week open label extension to trials assessing the safety and efficacy of BI 1356 (5 mg) as monotherapy or in combination with other antidiabetic medications in type 2 diabetic patients.

• IRAS ID

  4125

• Contact name

  John Reckless

• Sponsor organisation

  Boehringer Ingelheim Ltd

• Eudract number

  2008-000750-13

• ISRCTN Number

  N/A

• Research summary

  This trial, 1218.40 - A 78 week open label extension to trials assessing the safety and efficacy of BI 1356 (5mg) as monotherapy or in combination with other antidiabetic medications in type 2 diabetic patients is a follow on trial for subjects who have completed one of four phase III trials (1218.15, 1218.16, 1218.17 or 1218.18) using BI 1356, a DPP-IV inhibitor. This follow-on trial will investigate the safety and tolerability of BI 1356 (5 mg once daily) given for 78 weeks as monotherapy or in combination with other antidiabetic medications used in the preceding trials. Preceding trials, note that only 1218.18 was performed in the UK. 1218.15 - A randomised, double-blind, placebo controlled, parallel group 24 week study to assess the efficacy and safety of BI 1356 (5 mg) in combination with 30 mg pioglitazone (both administered orally once daily), compared to 30 mg pioglitazone plus placebo in drug naive or previously treated type 2 diabetic patients with insufficient glycaemic control.1218.16 - A randomised, double-blind, placebo-controlled parallel group efficacy and safety study of BI 1356 (5 mg administered orally once daily) over 24 weeks, in drug naive or previously treated (6 weeks washout) type 2 diabetic patients with insufficient glycaemic control1218.17 - A randomised, double-blind, placebo-controlled parallel group efficacy and safety study of BI 1356 (5 mg administered orally once daily) over 24 weeks in type 2 diabetic patients with insufficient glycaemic control despite metformin therapy1218.18 - A randomised, double-blind, placebo-controlled parallel group efficacy and safety study of BI 1356 (5 mg) administered orally once daily over 24 weeks in type 2 diabetic patients with insufficient glycaemic control despite a therapy of metformin in combination with a sulphonylurea

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  08/H1208/42

• Date of REC Opinion

  3 Oct 2008

• REC opinion

  Further Information Favourable Opinion