A Study to Assess the Efficacy and Safety of ASP1941 in Asian Subjects With Type 2 Diabetes Mellitus

• Status: Terminated
• Trial end date: 2012-10-19
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the efficacy of ASP1941 based on the changes in HbA1C as well as its safety in Asian subjects with type 2 diabetes mellitus.

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

Details

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

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 6 weeks before the study

• for the hypoglycemic agent non-naïve subject, subject has been receiving a single hypoglycemic agent or low-dose of a dual combination therapy

• BMI of 20.0 to 45.0 kg/m2

• for the hypoglycemic agent non-naïve subject, subject has a HbA1c value between 6.8 and 10.0% at screening AND has a HbA1c value between 7.0 and 10.0%, inclusive, at run-in period

• for the hypoglycemic agent naïve subject, subject has a HbA1c value between 7.0 and 10.0%, inclusive, at run-in period

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, acarbose or other alpha-GI

• 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