Renal Impairment Study of Empagliflozin (BI10773) in Japanese Patients With Type 2 Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: BI10773
* Drug: BI10773
* Drug: BI10773
* Drug: BI10773


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Type 2 diabetes patients Glycosylated haemoglobin>= 6.1% (Japan Diabetes Society) Estimated glomerular filtration rate based on the modification of diet in renal disease-formula at screening , of >= 15 mL/min/1.73m2 Exclusion criteria: Any evidence of significant disease (other than renal impairment) Moderate and severe concurrent liver function impairment Gastrointestinal tract surgery, that might affect absorption and elimination of drugs Diseases of the central nervous system (such as epilepsy), psychiatric disorders, or neurological disorders Chronic or relevant acute infections Participation in another trial with investigational drug administration within 30 days prior to study drug administration or during the trial

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BI10773 medium dose group 1<br>BI10773 medium dose tablet single dose group 1 | Drug: BI10773<br>* BI10773 medium dose tablet single dose<br>|
| Experimental: BI10773 medium dose group 2<br>BI10773 medium dose tablet single dose group 2 | Drug: BI10773<br>* BI10773 medium dose tablet single dose<br>|
| Experimental: BI10773 Medium dose group 3<br>BI10773 medium dose tablet single dose group 3 | Drug: BI10773<br>* BI10773 medium dose tablet single dose<br>|
| Experimental: BI10773 Medium dose group 4<br>BI10773 medium dose tablet single dose group 4 | Drug: BI10773<br>* BI10773 medium dose tablet single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Total Urinary Glucose Excretion (UGE) | change from baseline in total urinary glucose excretion (UGE) to 24 hours | baseline and 24 hours | 
| Area Under the Concentration Time Curve of the Analyte in Plasma | Area under the concentration time curve of the analyte in plasma over the time interval from 0 to infinity | 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 | Maximum concentration 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 |