A Study to Assess the Efficacy and Safety of ASP1941 in Combination With Metformin in Asian Diabetes Patients

• Status: Completed
• Trial end date: 2013-01-14
• Target enrollment: 0
• Participant gender: All

Summary

To compare the efficacy and safety of ASP1941 + metformin with metformin alone in Asian subjects with type 2 diabetes mellitus.

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

Details

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

Criteria

Inclusion Criteria:

• Diagnosed as type 2 diabetes mellitus patient at least 12 weeks before the study

• Stable diet and exercise program for at least 8 weeks before the study

• On a stable dose of at least 1500 mg/day metformin monotherapy or at least 1000 mg/day metformin monotherapy for the subject who can not titrate up to 1500 mg/day due to safety concern of metformin

• BMI of 20.0 to 45.0 kg/m2

• A HbA1c value between 7.0 and 10.0% at screening AND does not meet any of discontinuation criteria on fasting plasma glucose

Exclusion Criteria:

• Type 1 diabetes mellitus

• Proliferative diabetic retinopathy

• Receiving insulin within 12 weeks prior to the study

• History of clinically significant renal disease(s)

• Significant dysuria caused by a neurogenic bladder or a benign prostate hypertrophy etc.

• Urinary tract infection or genital infection

• Continuous use of systemic corticosteroids, immunosuppressants, or loop diuretics

• History of cerebrovascular attack, unstable angina, myocardial infarction, angioplasty, serious cardiac diseases within 12 weeks prior to the study

• Severe infection, serious trauma, or perioperative subject

• Known or suspected hypersensitivity to ASP1941

• History of treatment with ASP1941

• Participated in another clinical study, postmarketing study or medical device study within 12 weeks before the study

• Serum creatinine value exceeding the upper limit of normal range

• Urinary microalbumin/urinary creatinine ratio >300 mg/g