CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 499 enrolled
Drug / intervention
Placebo +5 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/NCT01210001
NCT01210001Phase 3Completed
CompareCT.gov

A Randomised, Double-blind, Placebo-controlled Parallel Group Efficacy and Safety Trial of BI 10773 (10 and 25 mg Administered Orally Once Daily) Over 24 Weeks in Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control Despite a Background Therapy of Pioglitazone Alone or in Combination With Metformin

Boehringer Ingelheim·interventional·Posted Sep 28, 2010·Updated Jun 17, 2014

In Brief

A Phase 3 clinical trial evaluating Placebo and BI 10773 for Diabetes Mellitus, Type 2. Completed, enrolled 499 participants across 68 sites in 7 countries.

Detailed Summary

This study will investigate the efficacy and safety of BI 10773 in type 2 diabetic patients in order to provide these data for approval for BI 10773 by regulatory authorities as an antidiabetic agent as add-on therapy to pioglitazone alone or in combination with metformin.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesCanada, Greece, India, Philippines, Thailand, Ukraine, United States
CollaboratorsEli Lilly and Company

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 28, 2010
Enrollment StartSep 1, 2010
Primary CompletionApr 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 15.8 years ago

Interventions

Placebodrug

Placebo tablets matching BI 10773 low dose

BI 10773drug

BI 10773 tablets once daily

Placebodrug

Placebo tablets matching BI 10773 high dose

Placebodrug

Placebo tablets matching BI 10773 high dose

Placebodrug

Placebo tablets matching BI 10773 high dose

BI 10773drug

BI 10773 tablets once daily