At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 278 enrolled
Drug / intervention
Placebo +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 Phase III, Randomised, Double Blind, Placebo Controlled Parallel Group Efficacy and Safety Study of Linagliptin 5 mg Administered Orally Once Daily Over 24 Weeks in Type 2 Diabetic Patients With Insufficient Glycaemic Control Despite a Therapy of Metformin in Combination With Pioglitazone
In Brief
A Phase 3 clinical trial evaluating Placebo and Linagliptin for Diabetes Mellitus, Type 2. Completed, enrolled 278 participants across 52 sites in 4 countries.
Detailed Summary
The objective of the current study is to investigate the efficacy, safety and tolerability of Linagliptin (5 mg once daily) compared to placebo given for 24 weeks as add on therapy to metformin in combination with pioglitazone in patients with type 2 diabetes mellitus with insufficient glycaemic control.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesFrance, India, Philippines, United States
CollaboratorsEli Lilly and Company
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2009
First PostedOct 2009
Primary CompletionMar 2012
TodayJul 2026
First PostedOct 16, 2009
Enrollment StartOct 1, 2009
Primary CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 16.7 years ago
Interventions
Placebodrug
Placebo matching linagliptin tablets once daily
Linagliptindrug
Linagliptin tablets once daily