Renal Impairment Study of Empagliflozin (BI10773) in Japanese Patients With Type 2 Diabetes
- Registration Number
- NCT01581658
- Lead Sponsor
- Boehringer Ingelheim
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
Inclusion Criteria
Not provided
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Exclusion Criteria
Not provided
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BI10773 medium dose group 1 BI10773 BI10773 medium dose tablet single dose group 1 BI10773 medium dose group 2 BI10773 BI10773 medium dose tablet single dose group 2 BI10773 Medium dose group 3 BI10773 BI10773 medium dose tablet single dose group 3 BI10773 Medium dose group 4 BI10773 BI10773 medium dose tablet single dose group 4
- Primary Outcome Measures
Name Time Method Change From Baseline in Total Urinary Glucose Excretion (UGE) baseline and 24 hours change from baseline in total urinary glucose excretion (UGE) to 24 hours
Maximum Concentration Predose and 20 minutes (min), 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 24h, 36h 48h, 72h and 96h after drug administration Maximum concentration of the analyte in plasma
Area Under the Concentration Time Curve of the Analyte in Plasma Predose and 20 minutes (min), 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 24h, 36h 48h, 72h and 96h after drug administration Area under the concentration time curve of the analyte in plasma over the time interval from 0 to infinity
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
1245.53.001 Boehringer Ingelheim Investigational Site
🇯🇵Kurume, Fukuoka, Japan