At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,058 enrolled
Drug / intervention
linagliptin +1 moredrug
Likely dose
placebo 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 (5 mg) Administered Orally Once Daily Over 24 Weeks, With an Open-label Extension to One Year (Placebo Patients Switched to BI 1356), in Type 2 Diabetic Patients With Insufficient Glycaemic Control Despite a Therapy of Metformin in Combination With a Sulphonylurea
In Brief
A Phase 3 clinical trial evaluating linagliptin and placebo for Diabetes Mellitus, Type 2. Completed, enrolled 1,058 participants across 100 sites in 11 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 combination with a sulphonylurea in patients with type 2 diabetes mellitus with insufficient glycaemic control.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesArgentina, Belgium, Canada, China, Germany, Philippines, Russia, South Korea, Taiwan, Turkey (Türkiye), United Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 2008
Enrollment StartFeb 2008
Primary CompletionMay 2009
TodayJul 2026
First PostedJan 28, 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 to linagliptin 5 mg