At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 561 enrolled
Drug / intervention
BI 1356 +4 moredrug
Likely dose
BI 1356 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 Double-blind Phase III Study to Evaluate the Efficacy of BI 1356 5 mg and 10 mg vs. Placebo for 12 Weeks and vs. Voglibose 0.6 mg for 26 Weeks in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control, Followed by an Extension Study to 52 Weeks to Evaluate Long-term Safety
In Brief
A Phase 3 clinical trial evaluating BI 1356, voglibose placebo, and 2 other interventions for Diabetes Mellitus, Type 2. Completed, enrolled 561 participants across 47 sites.
Detailed Summary
The objective of the current study is to investigate the efficacy, safety and tolerability of Linagliptin (BI 1356) (5 mg or 10 mg / once daily) compared to placebo given for 12 weeks and voglibose for 26 weeks as mono therapy in patients with type 2 diabetes mellitus with insufficient glycaemic control. Furthermore, long-term safety is evaluated with an extension treatment to 52 weeks.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartApr 2008
First PostedApr 2008
Primary CompletionJan 2010
TodayJul 2026
First PostedApr 8, 2008
Enrollment StartApr 1, 2008
Primary CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 18.2 years ago
Interventions
BI 1356drug
5 mg/daily
BI 1356drug
10 mg/daily
voglibose placebodrug
three times daily
BI 1356 placebodrug
once daily
voglibosedrug
0.6 mg/daily