At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 306 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 Randomized, Double-blind, Placebo-controlled Parallel Group Efficacy and Safety Study of BI 1356 Over 24 Weeks in T2D Patients With Insufficient Glycaemic Control Despite Metformin Therapy
In Brief
A Phase 3 clinical trial evaluating Linagliptin and placebo for Diabetes Mellitus, Type 2. Completed, enrolled 306 participants across 19 sites in 3 countries.
Detailed Summary
In this randomised, double-blind, parallel group trial, the safety and efficacy of 5 mg of Linagliptin administered orally once daily will be compared with a placebo after 24 weeks of treatment as add-on therapy to metformin in patients with type 2 diabetes and insufficient glycaemic control.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesChina, Malaysia, Philippines
CollaboratorsEli Lilly and Company
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2010
First PostedOct 2010
Primary CompletionApr 2012
TodayJul 2026
First PostedOct 6, 2010
Enrollment StartOct 1, 2010
Primary CompletionApr 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 15.7 years ago
Interventions
Linagliptindrug
once a day
placebodrug
once a day