CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 567 enrolled
Drug / intervention
Linagliptin + metformin +2 moredrug
Likely dose
Linagliptin + metformin 500 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.

Search/NCT00915772
NCT00915772Phase 3Completed
CompareCT.gov

Extension Study Linagliptin 2.5 mg Bid + Metformin 500 or 1000 mg Bid Versus Metformin 1000 mg Bid

Boehringer Ingelheim·interventional·Posted Jun 8, 2009·Updated May 14, 2014

In Brief

A Phase 3 clinical trial evaluating Linagliptin + metformin, Linagliptin+metformin, and 1 other intervention for Diabetes Mellitus, Type 2. Completed, enrolled 567 participants across 112 sites in 14 countries.

Detailed Summary

A phase III randomised, double-blind parallel group extension study to investigate the efficacy and safety of twice daily administration of the free combination of linagliptin 2.5 mg + metformin 500 mg or of linagliptin 2.5 mg + metformin 1000 mg versus monotherapy with metformin 1000 mg twice daily over 54 weeks in type 2 diabetic patients previously completing the double-blind part of study 1218.46

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesCanada, Croatia, Estonia, France, Germany, India, Lithuania, Mexico, Netherlands, Romania, Russia, Sweden, Tunisia, Ukraine
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 8, 2009
Enrollment StartJun 1, 2009
Primary CompletionJun 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 17.1 years ago

Interventions

Linagliptin + metformindrug

Linagliptin tablet low dose + metformin tablet 500 mg bid

Linagliptin+metformindrug

Linagliptin low dose tablet + metformin 1000 mg tablet bid

Metformindrug

Metformin 1000 mg tablet bid