A Study to Assess the Efficacy and Safety of ASP1941 in Combination With Metformin in Type 2 Diabetic Patients

• Status: Completed
• Trial end date: 2011-11-28
• Target enrollment: 0
• Participant gender: All

Summary

This study is to evaluate the efficacy and safety after concomitant administration of ASP1941 and metformin in patients with diabetes mellitus.

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

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Ipragliflozin; Metformin

Criteria

Inclusion Criteria:

• Type 2 diabetic patients receiving with metformin mono-therapy for at least 6 weeks

• HbA1c value between 7.0 and 9.5%

• Body Mass Index (BMI) 20.0 - 45.0 kg/m2

Exclusion Criteria:

• Type 1 diabetes mellitus patients

• Serum creatinine > upper limit of normal

• Estimated GFR < 60ml/min/1.73m2

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

• Dysuria and/or urinary tract infection, genital infection

• Significant renal, hepatic or cardiovascular diseases

• Severe gastrointestinal diseases