CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,705 enrolled
Drug / intervention
BI 10773 +29 moredrug
Likely dose
Sitagliptin 100mgfrom 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/NCT01289990
NCT01289990Phase 3Completed
CompareCT.gov

A Phase III Double-blind, Extension, Placebo-controlled Parallel Group Safety and Efficacy Trial of BI 10773 (10 and 25mg Once Daily) and Sitagliptin (100mg Once Daily) Given for Minimum 76 Weeks (Incl. 24 Weeks of Preceding Trial) as Monotherapy or With Different Back-ground Therapies in Patients With Type 2 Diabetes Mellitus Previously Completing Trial 1245.19, 1245.20 or 1245.23

Boehringer Ingelheim·interventional·Posted Feb 4, 2011·Updated Jul 15, 2014

In Brief

A Phase 3 clinical trial evaluating BI 10773, Placebo, and 1 other intervention for Diabetes Mellitus, Type 2. Completed, enrolled 2,705 participants across 243 sites in 19 countries.

Detailed Summary

This study will investigate the efficacy and long term safety and tolerability of BI 10773 in type 2 diabetic patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesBelgium, Canada, China, France, Germany, Greece, India, Ireland, Japan, Mexico, Philippines, Slovakia, Slovenia, South Korea, Switzerland, Taiwan, Turkey (Türkiye), Ukraine, United States
CollaboratorsEli Lilly and Company

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 4, 2011
Enrollment StartFeb 1, 2011
Primary CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 15.4 years ago

Interventions

BI 10773drug

BI 10773 tablets once daily

Placebodrug

Placebo matching BI 10773 low dose

Placebodrug

Placebo matching BI 10773 high dose

Placebodrug

Placebo matching Sitagliptin

Placebodrug

Placebo matching BI 10773 high dose

Placebodrug

Placebo matching BI 10773 high dose

BI 10773drug

BI 10773 tablets once daily

Placebodrug

Placebo matching BI 10773 low dose

Placebodrug

Placebo matching BI 10773 low dose

BI 10773drug

BI 10773 tablets once daily

Placebodrug

Placebo matching BI 10773 low dose

Placebodrug

Placebo matching BI 10773 high dose

Placebodrug

Placebo matching Sitagliptin

BI 10773drug

BI 10773 tablets once daily

BI 10773drug

BI 10773 tablets once daily

BI 10773drug

BI 10773 tablets once daily

Placebodrug

Placebo matching BI 10773 high dose

BI 10773drug

BI 10773 tablets once daily

Placebodrug

Placebo matching BI 10773 low dose

Placebodrug

Placebo matching BI 10773 high dose

Placebodrug

Placebo matching Sitagliptin

Sitagliptin 100mgdrug

Sitagliptin once daily

BI 10773drug

BI 10773 tablets once daily

Placebodrug

Placebo matching BI 10773 low dose

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 low dose

Placebodrug

Placebo matching BI 10773 high dose

Placebodrug

Placebo matching BI 10773 high dose