At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 133 enrolled
Drug / intervention
BI 1356 +1 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.
Safety in Type 2 Diabetic Patients With Severe Chronic Renal Impairment, 5 mg BI 1356 vs. Placebo, DB, Parallel Group, Randomized, Insulin Background Inclusive
In Brief
A Phase 3 clinical trial evaluating BI 1356 and placebo for Diabetes Mellitus, Type 2. Completed, enrolled 133 participants across 53 sites in 6 countries.
Detailed Summary
to determine safety, efficacy and tolerability of BI 1356 versus placebo
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesAustralia, Hong Kong, Israel, New Zealand, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartDec 2008
First PostedDec 2008
Primary CompletionJan 2011
TodayJul 2026
First PostedDec 2, 2008
Enrollment StartDec 1, 2008
Primary CompletionJan 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 17.6 years ago
Interventions
BI 1356drug
BI 1356 dosed once daily
placebodrug
placebo matching BI 1356 taken once daily