A Study of ASP1941 in Japanese Patients With Type 2 Diabetes Mellitus

• Status: Completed
• Trial end date: 2010-03-26
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose of this study is to evaluate the pharmacodynamic profile (blood glucose and urinary glucose excursion) of ASP1941 in patients with type 2 diabetes mellitus. Safety, tolerability and pharmacokinetics are also evaluated.

• Phase: Phase 1
• 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 7.0 and 10.0% at screening

• Fasting plasma glucose ≥ 126mg/dL and < 240mg/dL at screening

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

• Significant renal, hepatic or cardiovascular diseases

• Severe gastrointestinal diseases