At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 245 enrolled
Drug / intervention
BI 1356 +1 moredrug
Likely dose
BI 1356 5mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Placebo-controlled Parallel Group Efficacy and Safety Study of BI 1356 (5 mg Administered Orally Once Daily) Over 18 Weeks in Type 2 Diabetic Patients With Insufficient Glycaemic Control (HbA1c 7.0-10%) Despite Background Therapy With a Sulfonylurea Drug.
In Brief
A Phase 3 clinical trial evaluating BI 1356 and Placebo for Diabetes Mellitus, Type 2. Completed, enrolled 245 participants across 45 sites in 7 countries.
Detailed Summary
Efficacy and safety of BI 1356 compared to placebo in patients with type 2 diabetes who have insufficient glycaemic control despite treatment with a sulfonylurea drug.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesArgentina, Hungary, India, Japan, Poland, Russia, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartDec 2008
First PostedJan 2009
Primary CompletionJan 2010
TodayJul 2026
First PostedJan 8, 2009
Enrollment StartDec 1, 2008
Primary CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 17.5 years ago
Interventions
BI 1356drug
5mg orally (po) tablet qd
Placebodrug
Placebo matching BI 1356 5mg one tablet daily