At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 227 enrolled
Drug / intervention
Linagliptin +2 moredrug
Likely dose
Linagliptin 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 Randomised, db, Placebo-controlled, Parallel Group Efficacy and Safety Study of BI 1356 (5mg), Administered Orally Once Daily for 18 Weeks Followed by a 34 Week Double-blind Extension Period (Placebo Patients Switched to Glimepiride) in Type 2 Diabetic Patients With Insufficient Glycaemic Control for Whom Metformin Therapy is Inappropriate (Intolerability or Contraindication)
In Brief
A Phase 3 clinical trial evaluating Linagliptin, Linagliptin Placebo, and 1 other intervention for Diabetes Mellitus, Type 2. Completed, enrolled 227 participants across 53 sites in 7 countries.
Detailed Summary
Efficacy of BI 1356 compared to placebo in patients for whom metformin therapy is inappropriate (intolerability, contraindication). The second part of the study looks at the safety of BI 1356 in this patient population with longer term treatment in comparison to a sulfonylurea drug (glimepiride)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesCanada, Mexico, Philippines, Romania, Russia, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2008
First PostedAug 2008
Primary CompletionAug 2010
TodayJul 2026
First PostedAug 22, 2008
Enrollment StartAug 1, 2008
Primary CompletionAug 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 17.9 years ago
Interventions
Linagliptindrug
5mg once daily
Linagliptin Placebodrug
0 mg placebo comparator for part 1 of study (to 18 weeks)
Glimepiridedrug
1-4mg for part 2 of study (weeks 19-52)