CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 689 enrolled
Drug / intervention
metformin placebo +4 moredrug
Likely dose
metformin placebo 500mgfrom 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/NCT01438814
NCT01438814Phase 4Completed
CompareCT.gov

A Randomised, Double-blind, Double-dummy, Active-comparator Controlled Study Investigating the Efficacy and Safety of Linagliptin Co-administered With Metformin QD at Evening Time Versus Metformin BID Over 14 Weeks in Treatment Naive Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control

Boehringer Ingelheim·interventional·Posted Sep 22, 2011·Updated Nov 25, 2014

In Brief

A Phase 4 clinical trial evaluating metformin placebo, linagliptin placebo, and 2 other interventions for Diabetes Mellitus, Type 2. Completed, enrolled 689 participants across 90 sites in 14 countries.

Detailed Summary

The aim of this study is to investigate the impact of the combination therapy of linagliptin and metformin at submaximal doses in reduction of Glycosylated haemoglobin (HbA1c) and metformin pre-specified gastro-intestinal (GI) side effects in treatment naive patients of with type 2 diabetes mellitus.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesBangladesh, Belgium, Canada, China, Germany, Guatemala, Hong Kong, India, Lebanon, Mexico, Peru, Philippines, Spain, Taiwan
CollaboratorsEli Lilly and Company

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 22, 2011
Enrollment StartNov 1, 2011
Primary CompletionMar 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 14.8 years ago

Interventions

metformin placebodrug

metformin placebo tablets 500mg

linagliptin placebodrug

linagliptin placebo tablets 5mg

metformindrug

metformin tablets 500mg

metformindrug

metformin tablets 500 mg

linagliptindrug

linagliptin tablets 5mg