A Study to Assess the Pharmacokinetics, Pharmacodynamics of ASP1941 in Diabetes Mellitus Patients With Renal Impairment

• Status: Completed
• Trial end date: 2010-06-18
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Ipragliflozin

Criteria

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