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
Overview
- Phase
- Phase 1
- Intervention
- BI10773
- Conditions
- Diabetes Mellitus, Type 2
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Total Urinary Glucose Excretion (UGE)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
BI10773 medium dose group 1
BI10773 medium dose tablet single dose group 1
Intervention: BI10773
BI10773 medium dose group 2
BI10773 medium dose tablet single dose group 2
Intervention: BI10773
BI10773 Medium dose group 3
BI10773 medium dose tablet single dose group 3
Intervention: BI10773
BI10773 Medium dose group 4
BI10773 medium dose tablet single dose group 4
Intervention: BI10773
Outcomes
Primary Outcomes
Change From Baseline in Total Urinary Glucose Excretion (UGE)
Time Frame: baseline and 24 hours
change from baseline in total urinary glucose excretion (UGE) to 24 hours
Maximum Concentration
Time Frame: 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
Time Frame: 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