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

A Phase 1, Randomized, Double-blind, Placebo Controlled, Monotherapy Study to Assess the Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of ASP1941 in Japanese Patients With Type 2 Diabetes Mellitus

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.

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