At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 7,064 enrolled
Drug / intervention
BI 10773 low dose +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.
A Phase III, Multicentre, International, Randomised, Parallel Group, Double Blind Cardiovascular Safety Study of BI 10773 (10 mg and 25 mg Administered Orally Once Daily) Compared to Usual Care in Type 2 Diabetes Mellitus Patients With Increased Cardiovascular Risk
In Brief
A Phase 3 clinical trial evaluating BI 10773 low dose, Placebo BI 10773 high dose, and 2 other interventions for Diabetes Mellitus, Type 2. Completed, enrolled 7,064 participants across 615 sites in 42 countries.
Detailed Summary
The aim of the present study is to investigate the safety of BI 10773 treatment in patients with Type 2 Diabetes Mellitus and high cardiovascular risk.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesArgentina, Australia, Austria, Belgium, Brazil, Canada, Colombia, Croatia, Czechia, Denmark, Estonia, France, Georgia, Greece, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, New Zealand, Norway, Peru, Philippines, Poland, Portugal, Romania, Russia, Singapore, South Africa, South Korea, Spain, Sri Lanka, Taiwan, Thailand, Ukraine, United Kingdom, United States
CollaboratorsEli Lilly and Company
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 2010
Enrollment StartJul 2010
Primary CompletionApr 2015
TodayJul 2026
First PostedMay 27, 2010
Enrollment StartJul 1, 2010
Primary CompletionApr 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 16.1 years ago
Interventions
BI 10773 low dosedrug
BI 10773 tablets once daily
Placebo BI 10773 high dosedrug
Placebo tablets identical to BI 10773
BI 10773 high dosedrug
BI 10773 tablets once daily
Placebo BI 10773 low dosedrug
Placebo tablets identical to BI 10773
Placebo BI 10773 low dosedrug
Placebo tablets identical to BI 10773
Placebo BI 10773 high dosedrug
Placebo tablets identical to BI 10773