At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 32 enrolled
Drug / intervention
BI10773 +3 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 I, Open-label, Parallel-group Study to Investigate Pharmacokinetics, Pharmacodynamics and Safety of a Single 25 mg Dose of Empagliflozin in Japanese Type 2 Diabetes Patients With Different Degrees of Renal Impairment in Comparison to Type 2 Diabetes Patients With Normal Renal Function
In Brief
A Phase 1 clinical trial evaluating BI10773 for Diabetes Mellitus, Type 2. Completed, enrolled 32 participants across 1 site.
Detailed Summary
The objective of this study is to assess the effect of the different degrees of renal impairment on the pharmacokinetics, pharmacodynamics and safety of BI10773 following oral administration of high dose BI10773 as a single dose in Japanese patients with type 2 diabetes mellitus.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesJapan
CollaboratorsEli Lilly and Company
Timeline
Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartApr 2012
First PostedApr 2012
Primary CompletionNov 2012
TodayJul 2026
First PostedApr 20, 2012
Enrollment StartApr 1, 2012
Primary CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 14.2 years ago
Interventions
BI10773drug
BI10773 medium dose tablet single dose
BI10773drug
BI10773 medium dose tablet single dose
BI10773drug
BI10773 medium dose tablet single dose
BI10773drug
BI10773 medium dose tablet single dose