CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 491 enrolled
Drug / intervention
linagliptin low dose +2 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.

Search/NCT01012037
NCT01012037Phase 2Completed
CompareCT.gov

12 Week Randomised Double-blind BI 1356 2.5 mg Bid vs 5 mg qd add-on to Metformin

Boehringer Ingelheim·interventional·Posted Nov 11, 2009·Updated Jun 27, 2014

In Brief

A Phase 2 clinical trial evaluating linagliptin low dose, placebo, and 1 other intervention for Diabetes Mellitus, Type 2. Completed, enrolled 491 participants across 84 sites in 9 countries.

Detailed Summary

The objective of the study is to investigate the efficacy and safety of linagliptin 2.5 mg twice daily compared to 5 mg once daily compared to placebo given orally for 12 weeks as add-on therapy to metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control. It is planned to show non-inferiority of linagliptin 2.5 mg twice daily compared to 5 mg once daily and each treatment's superiority over placebo.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesBelgium, Canada, France, India, Italy, Malaysia, Netherlands, South Korea, Spain
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 11, 2009
Enrollment StartNov 1, 2009
Primary CompletionSep 1, 2010
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 16.6 years ago

Interventions

linagliptin low dosedrug

patient to receive tablets containing low dose linagliptin twice daily

placebodrug

patient to receive placebo tablet(s) matching linagliptin

linagliptin medium dosedrug

patient to receive a tablet containing medium dose linagliptin once daily