At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III Randomised, Double-blind, Placebo-controlled Parallel Group Study to Compare the Efficacy and Safety of Twice Daily Administration of the Free Combination of BI 1356 2.5 mg + Metformin 500 mg, or of BI 1356 2.5 mg + Metformin 1000 mg, With the Individual Components of Metformin (500 mg or 1000 mg Twice Daily), and BI 1356 (5.0 mg Once Daily) Over 24 Weeks in Drug Naive or Previously Treated (4 Weeks Wash-out and 2 Weeks Placebo run-in) Type 2 Diabetic Patients With Insufficient Glycaemic Control
In Brief
A Phase 3 clinical trial evaluating BI 1356, BI 1356 + metformin, and 4 other interventions for Diabetes Mellitus, Type 2. Completed, enrolled 857 participants across 138 sites in 14 countries.
Detailed Summary
The objective of the randomised part of the study is to investigate the efficacy and safety of BI 1356 plus metformin compared to BI 1356 or metformin alone given for 24 weeks to drug naive or previously treated (4 weeks wash-out, 2 weeks placebo run-in) type 2 diabetic patients with insufficient glycaemic control. For the open-label part of the study the objective is to estimate the efficacy and safety of BI 1356 and metformin in type 2 diabetic patients with very poor glycaemic control for 24 weeks
Study Details
Timeline
Interventions
BI 1356 high dose tablet, once daily
BI 1356 low dose tablet + Metformin 500 mg tablet, twice daily
BI 1356 low dose tablet + Metformin 1000 mg tablet, twice daily
Metformin 500 mg tablet, twice daily
metformin 1000 mg tablet, twice daily
matching placebo