A Study to Assess the Long-term Safety and Efficacy of ASP1941 in Japanese Diabetic Patients

• Status: Completed
• Trial end date: 2011-07-22
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to evaluate the long-term safety of ASP1941 in patients with type 2 diabetes mellitus. The second objectives are to compare the efficacy and pharmacokinetics of ASP1941 administered before or after food intake.

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

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Ipragliflozin

Criteria

Inclusion Criteria:

• Type 2 diabetic patients for at least 12 weeks

• HbA1c value between 6.5 and 9.5%

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

Exclusion Criteria:

• Type 1 diabetes mellitus patients

• 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

• Proliferative diabetic retinopathy