At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 701 enrolled
Drug / intervention
linagliptin +1 moredrug
Likely dose
linagliptin 5 mgfrom 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-controlled Parallel Group Efficacy and Safety Study of BI 1356 (One Dose, e.g. 5 mg), Administered Orally Once Daily Over 24 Weeks, With an Open Label Extension to 80 Weeks (Placebo Patients Switched to BI 1356), in Type 2 Diabetic Patients With Insufficient Glycaemic Control Despite Metformin Therapy
In Brief
A Phase 3 clinical trial evaluating linagliptin for Diabetes Mellitus, Type 2. Completed, enrolled 701 participants across 82 sites in 10 countries.
Detailed Summary
The objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (5 mg once daily) compared to placebo given for 24 weeks as add-on therapy to metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesCzechia, Finland, Greece, India, Israel, Mexico, New Zealand, Russia, Sweden, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2008
First PostedJan 2008
Primary CompletionMay 2009
TodayJul 2026
First PostedJan 28, 2008
Enrollment StartJan 1, 2008
Primary CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 18.4 years ago
Interventions
linagliptindrug
Patients receive linagliptin 5 mg tablets once daily
linagliptindrug
Patients receive linagliptin 5 mg tablets once daily