CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,504 enrolled
Drug / intervention
Placebo identical to BI 10773 high dose +6 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/NCT01159600
NCT01159600Phase 3Completed
CompareCT.gov

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

Boehringer Ingelheim·interventional·Posted Jul 9, 2010·Updated Jun 17, 2014

In Brief

A Phase 3 clinical trial evaluating Placebo identical to BI 10773 high dose, Placebo identical to BI 10773 low dose, and 1 other intervention for Diabetes Mellitus, Type 2. Completed, enrolled 1,504 participants across 148 sites in 12 countries.

Detailed Summary

The objective of the current study is to investigate the efficacy, safety and tolerability of two doses of BI 10773 compared to placebo given for 24 weeks as add-on therapy to metformin or metformin plus sulfonylurea in patients with Typ 2 Diabetes Mellitus with insufficient glycaemic control.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesCanada, China, France, Germany, India, Mexico, Slovakia, Slovenia, South Korea, Taiwan, Turkey (Türkiye), United States
CollaboratorsEli Lilly and Company

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 9, 2010
Enrollment StartJul 1, 2010
Primary CompletionFeb 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 16.0 years ago

Interventions

Placebo identical to BI 10773 high dosedrug

Placebo tablets matching BI 10773 high dose

Placebo identical to BI 10773 low dosedrug

Placebo tablets matching BI 10773 low dose

BI 10773drug

BI 10773 tablets once daily high dose open label

BI 10773drug

BI 10773 tablets once daily high dose

Placebo identical to BI 10773 low dosedrug

Placebo tablets matching BI 10773 low dose

BI 10773drug

BI 10773 tablets once daily low dose

Placebo identical to BI 10773 high dosedrug

Placebo tablets matching BI 10773 high dose