CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 986 enrolled
Drug / intervention
Placebo identical to BI10773 high dose +12 moredrug
Likely dose
Placebo identical to 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/NCT01177813
NCT01177813Phase 3Completed
CompareCT.gov

A Phase III Randomised, Double-blind, Placebo-controlled Parallel Group Efficacy and Safety Study of BI 10773 and Sitagliptin Administered Orally Over 24 Weeks, in Drug naïve Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control Despite Diet and Exercise

Boehringer Ingelheim·interventional·Posted Aug 9, 2010·Updated Jun 16, 2014

In Brief

A Phase 3 clinical trial evaluating Placebo identical to BI10773 high dose, BI 10773, and 5 other interventions for Diabetes Mellitus, Type 2. Completed, enrolled 986 participants across 124 sites in 9 countries.

Detailed Summary

The aim of this study is to investigate the efficacy, safety and tolerability of BI 10773 compared to placebo and sitagliptin given for 24 weeks as monotherapy in patients with T2DM with insufficient glycaemic control. For the open-label part of the study the objective is to estimate the efficacy and safety of BI 10773 when given for 24 weeks in patients with T2DM with very poor glycaemic control.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesBelgium, Canada, China, Germany, India, Ireland, Japan, Switzerland, United States
CollaboratorsEli Lilly and Company

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 9, 2010
Enrollment StartJul 1, 2010
Primary CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 15.9 years ago

Interventions

Placebo identical to BI10773 high dosedrug

placebo tablets once daily

BI 10773drug

BI 10773 low dose tablet once daily

BI 10773 open labeldrug

Patients receive BI 10773 high dose tablets open label once daily

Placebo identical to BI10773 low dosedrug

placebo tablets once daily

Placebo identical to BI10773 low dosedrug

placebo tablets once daily

Placebo identical to BI10773 high dosedrug

placebo tablets once daily

Placebo identical to Sitagliptin 100mgdrug

placebo tablets once daily

Placebo identical to Sitagliptin 100mgdrug

placebo tablets once daily

BI10773drug

BI 10773 high dose tablets once daily

Sitagliptindrug

Sitagliptin tablets 100 mg once daily

Placebo identical to Sitagliptin 100mgdrug

placebo tablets once daily

Placebo identical to BI10773 low dosedrug

placebo tablets once daily

Placebo identical to BI10773 high dosedrug

placebo tablets once daily