CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,405 enrolled
Drug / intervention
high dose FDC +24 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/NCT01422876
NCT01422876Phase 3Completed
CompareCT.gov

A Phase III Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Once Daily Oral Administration of BI 10773 25 mg/Linagliptin 5 mg and BI 10773 10 mg/Linagliptin 5 mg Fixed Dose Combination Tablets Compared With the Individual Components (BI 10773 25 mg, BI 10773 10 mg, and Linagliptin 5 mg) for 52 Weeks in Treatment naïve and Metformin Treated Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control

Boehringer Ingelheim·interventional·Posted Aug 25, 2011·Updated Apr 2, 2015

In Brief

A Phase 3 clinical trial evaluating high dose FDC, BI 10773 high dose, and 9 other interventions for Diabetes Mellitus, Type 2. Completed, enrolled 1,405 participants across 211 sites in 22 countries.

Detailed Summary

This trial will evaluate use of BI 10773/linagliptin once daily (qd) fixed dose combination (FDC) in treatment naïve and metformin treated patients with type 2 diabetes mellitus to support approval by regulatory authorities.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesArgentina, Australia, Brazil, Bulgaria, Canada, Colombia, Denmark, Estonia, Hungary, Italy, Lebanon, Malaysia, Mexico, Peru, Philippines, Poland, Romania, Russia, Spain, Sweden, Taiwan, United States
CollaboratorsEli Lilly and Company

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 25, 2011
Enrollment StartAug 1, 2011
Primary CompletionSep 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 14.9 years ago

Interventions

high dose FDCdrug

once daily

BI 10773 high dosedrug

once daily

high dose FDC placebodrug

once daily

low dose FDC placebodrug

once daily

high dose FDC placebodrug

once daily

high dose FDC placebodrug

once daily

low dose FDC placebodrug

once daily

low dose FDC placebodrug

once daily

high dose BI 10773 placebodrug

once daily

low dose FDCdrug

once daily

high dose FDC placebodrug

once daily

BI 10773 low dosedrug

low dose once daily

high dose BI 10773 placebodrug

once daily

high dose BI 10773 placebodrug

once daily

linagliptindrug

once daily

low dose FDC placebodrug

once daily

linagliptin placebodrug

once daily

BI 10773 low dose placebodrug

once daily

linagliptin placebodrug

once daily

low dose BI 10773 placebodrug

once daily

linagliptin placebodrug

once daily

high dose BI 10773 placebodrug

once daily

BI 10773 low dose placebodrug

once daily

low dose BI 10773 placebodrug

once daily

linagliptin placebodrug

once daily