At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 503 enrolled
Drug / intervention
linagliptin +1 moredrug
Likely dose
Not stated in 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 Randomised, Double-blind, Placebo-controled 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 Glycemic Control
In Brief
A Phase 3 clinical trial evaluating linagliptin and placebo for Diabetes Mellitus, Type 2. Completed, enrolled 503 participants across 69 sites in 11 countries.
Detailed Summary
To investigate efficacy, safety and tolerability of BI 1356 versus placebo
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesCroatia, India, Israel, Italy, Malaysia, Netherlands, Poland, Romania, Slovakia, Thailand, Ukraine
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2008
First PostedFeb 2008
Primary CompletionMay 2009
TodayJul 2026
First PostedFeb 22, 2008
Enrollment StartFeb 1, 2008
Primary CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 18.4 years ago
Interventions
linagliptindrug
active
placebodrug
placebo