At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 100 enrolled
Drug / intervention
Placebo (middle dose) +7 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 II, Randomised, Double-blind, Placebo-controlled, Multiple Dose Study to Evaluate Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of Once Daily Oral Administration of BI 10773 (1 mg, 5 mg, 10 mg, and 25 mg) for 28 Days in Japanese Patients With Type 2 Diabetes Mellitus
In Brief
A Phase 2 clinical trial evaluating Placebo (middle dose), Placebo, and 3 other interventions for Diabetes Mellitus, Type 2. Completed, enrolled 100 participants across 5 sites.
Detailed Summary
The objective of this trial is to evaluate the pharmacodynamics, pharmacokinetics, safety, and tolerability of once daily oral administration of BI 10773 administered for 28 days in Japanese patients with T2DM.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesJapan
Collaborators--
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartApr 2009
First PostedApr 2009
Primary CompletionOct 2009
TodayJul 2026
First PostedApr 21, 2009
Enrollment StartApr 1, 2009
Primary CompletionOct 1, 2009
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 17.2 years ago
Interventions
Placebo (middle dose)drug
Placebo tablets once a day
Placebodrug
Placebo tablets once a day
BI 10773drug
BI 10773 middle dose tablets once a day
BI 10773drug
BI 10773 high dose tablets once a day
BI 10773drug
BI 10773 middle dose tablets once a day
Placebo (high dose)drug
Placebo tablets once a day
BI 10773drug
BI 10773 low dose tablets once a day
Placebo (low dose)drug
Placebo tablets once a day