A Study to Assess Efficacy and Safety of ASP1941 in Diabetic Patients With Renal Impairment

• Status: Completed
• Trial end date: 2012-11-28
• Target enrollment: 0
• Participant gender: All

Summary

This study is to assess the effect of renal function on the efficacy and safety of ASP1941 in type 2 diabetic patients with mild to moderate renal impairment.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Ipragliflozin

Criteria

Inclusion Criteria:

• type 2 diabetes mellitus patient

• subject has been on an exercise program and stable diet, or one oral hypoglycemic agent (alpha-glucosidase inhibitor, sulfonylurea agent and pioglitazone)

• estimated GFR value based on the Japanese GFR estimation equation of ≥ 30 mL/min/1.73 m2 and < 90 mL/min/1.73 m2

• HbA1C value between 6.5 and 8.5%

• body mass index (BMI) 29.0 - 45.0 kg/m2

Exclusion Criteria:

• type 1 diabetes mellitus patients

• proliferative diabetic retinopathy

• subject has received insulin within 12 weeks before the study

• subject has a chronic disease which requires the continuous use of adrenocortical steroids, immunosuppressant, and loop diuretic

• serum creatinine > upper limit of normal

• proteinuria (albumin/creatinine ratio > 300mg/g)

• dysuria and/or urinary tract infection, genital infection

• significant renal, hepatic or cardiovascular diseases

• severe gastrointestinal diseases