At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Placebo-controlled, Five Parallel Group Study Investigating the Efficacy and Safety of BI 1356 BS (0.5 mg, 2.5 mg and 5.0 mg Administered Orally Once Daily) Over 12 Weeks in Drug Naive and Treated Patients With Type 2 Diabetes With Insufficient Glycemic Control (Study Includes an Open-label Metformin Treatment Arm)
In Brief
A Phase 2 clinical trial evaluating Placebo, BI 1356 dose 3 once daily, and 3 other interventions for Diabetes Mellitus, Type 2. Completed, enrolled 302 participants across 71 sites in 6 countries.
Detailed Summary
The objective of the current study is to investigate the efficacy, safety and tolerability of several doses of BI 1356 BS (0.5, 2.5 and 5 mg daily) compared to placebo over 12 weeks of treatment in patients with Type 2 diabetes and insufficient glycemic control. In addition, there will be an open-label treatment arm with metformin for sensitivity measurement with this patient population. Population pharmacokinetics of BI 1356 BS will also be assessed in this study.
Study Details
Timeline
Interventions
Placebo matching BI 1356
BI 1356 dose 3 once daily
BI 1356 dose 2 once daily
BI 1356 dose 1 once daily
Metformin