A Study to Assess the Pharmacokinetics, Pharmacodynamics of ASP1941 in Diabetes Mellitus Patients With Renal Impairment
- Registration Number
- NCT01097681
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
The primary objective of this study is to compare the pharmacokinetics of ASP1941 in type 2 diabetes mellitus patients with normal renal function and those with mild or moderate renal impairment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
Inclusion Criteria
- Type 2 diabetic patients for at least 12 weeks
- Fasting plasma glucose level of < 240 mg/dL
- Body Mass Index ( BMI )20.0 - 35.0kg/m2
- GFR value based on the Japanese GFR estimation equation at screening, of ≥ 30 ml/min/1.73m2
Exclusion Criteria
- Type 1 diabetes mellitus patients
- Receiving insulin within 12 weeks before screening
- Diabetic ketoacidosis
- Dysuria and/or urinary tract infection, genital infection
- Significant renal, hepatic or cardiovascular diseases
- Severe gastrointestinal diseases
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Normal renal function group ASP1941 oral Mild renal impairment group ASP1941 oral Moderate renal impairment group ASP1941 oral
- Primary Outcome Measures
Name Time Method Plasma concentration of ASP1941 For 72 hours after dosing
- Secondary Outcome Measures
Name Time Method Urinary levels of ASP1941 For 72 hours after dosing Safety assessed by adverse events, vital signs, laboratory tests and 12-lead ECGs For 72 hours after dosing Urinary glucose excretion For 72 hours after dosing