CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 876 enrolled
Drug / intervention
linagliptin2.5mg/metformin1000mg +7 moredrug
Likely dose
linagliptin2.5mg/metformin1000mgfrom 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.

Search/NCT01708902
NCT01708902Phase 3Completed
CompareCT.gov

A Phase III Randomised, Double-blind, Double-dummy, Parallel Group Study to Compare the Efficacy and Safety of Twice Daily Administration of the Fix Dose Combination of Linagliptin 2.5 mg + Metformin 500 mg, or of Linagliptin 2.5 mg + Metformin 1000 mg, With the Individual Components of Metformin (500 mg or 1000 mg, Twice Daily), and Linagliptin (5.0 mg, Once Daily) Over 24 Weeks in Treatment naïve Type 2 Diabetic Patients With Insufficient Glycaemic Control

Boehringer Ingelheim·interventional·Posted Oct 17, 2012·Updated Apr 24, 2015

In Brief

A Phase 3 clinical trial evaluating linagliptin2.5mg/metformin1000mg, linagliptin 5mg, and 3 other interventions for Diabetes Mellitus, Type 2. Completed, enrolled 876 participants across 56 sites in 4 countries.

Detailed Summary

Reduced factorial design study with 24 week randomized treatment of initial combination therapy with linagliptin and metformin in T2DM patients

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesChina, Malaysia, Philippines, Vietnam
CollaboratorsEli Lilly and Company

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 17, 2012
Enrollment StartOct 1, 2012
Primary CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 13.7 years ago

Interventions

linagliptin2.5mg/metformin1000mgdrug

linagliptin2.5mg/metformin1000mg BID

linagliptin2.5mg/metformin1000mgdrug

linagliptin2.5mg/metformin1000mg BID

linagliptin 5mgdrug

linagliptin 5mg once daily

Metformin 500mgdrug

Metformin 500mg BID

linagliptin2.5mg/metformin500mgdrug

linagliptin2.5mg/metformin500mg BID

linagliptin2.5mg/metformin500mgdrug

linagliptin2.5mg/metformin500mg BID

linagliptin 5mgdrug

linagliptin 5mg once daily

Metformin 1000mgdrug

Metformin 1000mg BID