CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 825 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/NCT01370005
NCT01370005Phase 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 12 Weeks in Hypertensive Patients With Type 2 Diabetes Mellitus

Boehringer Ingelheim·interventional·Posted Jun 9, 2011·Updated Feb 22, 2016

In Brief

A Phase 3 clinical trial evaluating Placebo and BI 10773 for Diabetes Mellitus, Type 2 and Hypertension. Completed, enrolled 825 participants across 120 sites in 12 countries.

Detailed Summary

This trial will evaluate safety and efficacy of BI 10773 in hypertensive patients with type 2 diabetes. Since hyperglycaemia and hypertension are key risk factors for both micro- and macrovascular complications, assessment of both glucose and blood pressure lowering effects of BI 10773 in hypertensive patients with type 2 diabetes could provide clinically highly relevant, new information for the use of BI 10773

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2, Hypertension
CountriesCanada, Czechia, Denmark, Estonia, Finland, France, Germany, Lebanon, Netherlands, Norway, Sweden, United States
CollaboratorsEli Lilly and Company

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 9, 2011
Enrollment StartJun 1, 2011
Primary CompletionJul 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 15.1 years ago

Interventions

Placebodrug

Placebo matching BI 10773 low dose

BI 10773drug

BI 10773 high dose once daily

Placebodrug

Placebo matching BI 10773 low dose

BI 10773drug

BI 10773 low dose once daily

Placebodrug

Placebo matching BI 10773 high dose

Placebodrug

Placebo matching BI 10773 high dose