CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 566 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/NCT01306214
NCT01306214Phase 3Completed
CompareCT.gov

A Phase III, Randomized, Double-blind, Placebo-controlled, Parallel Group Safety and Efficacy Study of BI 10773 (10 mg and 25 mg Administered Orally Once Daily) During 52 Weeks in Patients With Type 2 Diabetes Mellitus and Insufficient Glycemic Control on MDI Insulin Regimen Alone or With Metformin

Boehringer Ingelheim·interventional·Posted Mar 1, 2011·Updated Jun 17, 2014

In Brief

A Phase 3 clinical trial evaluating Placebo and BI 10773 for Diabetes Mellitus, Type 2 and Obesity. Completed, enrolled 566 participants across 103 sites in 14 countries.

Detailed Summary

This trial will evaluate use of BI 10773 as add-on to insulin regimen alone or with metformin in patients with typr 2 diabetes. Both lowering glucose and HbA1c and reducing the use of insulin in this population would provide significant new information for the BI 10773 use and would offer a potential new therapeutic option in this population.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2, Obesity
CountriesBelgium, Bulgaria, Colombia, Czechia, Finland, France, Germany, Guatemala, Mexico, Peru, Russia, Spain, Ukraine, United States
CollaboratorsEli Lilly and Company

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 1, 2011
Enrollment StartFeb 1, 2011
Primary CompletionApr 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 15.3 years ago

Interventions

Placebodrug

Placebo matching BI 10773 low dose

Placebodrug

Placebo matching BI 10773 low dose

Placebodrug

Placebo matching BI 10773 high dose

Placebodrug

Placebo matching BI 10773 high dose

BI 10773drug

BI 10773 low dose once daily

BI 10773drug

BI 10773 high dose once daily