Drug to Drug Interaction Study With ASP1941 and Metformin

A Double-blind, Randomized, Placebo-controlled, Parallel Design Study, in Patients With Type 2 Diabetes Mellitus, to Investigate the Safety, Pharmacokinetics and Pharmacodynamics Interactions of Multiple Oral Doses of ASP1941 and Metformin

A study to investigate the effect on safety, pharmacokinetics and pharmacodynamics when ASP1941 is administered as add-on therapy to metformin.

Inclusion Criteria:

• Subjects with type 2 diabetes
• Stable disease under metformin monotherapy (between 1500-3000

mg/day) or dual therapy with metformin (1500-3000 mg/day) and a Sulfonylureum Derivative (SUD) for at least 3 months

• Fasting Serum Glucose: 7-11.5 mmol/l (after wash-out)
• Stable Fasting Blood Glucose (FBG) at the end of wash-out
• BMI between 18.5 and 40.0 kg/m2, inclusive

Exclusion Criteria:

• Subjects with type 1 diabetes
• Any diabetes related macro-complications, painful diabetic neuropathy, diabetic macular edema or diabetic proliferative retinopathy
• Clinical significant renal disease (CLcr <60 ml/min as assessed during a 24h creatinine clearance on Day-2
• Recent evidence (e.g. within the last 6 months) of severe hypoglycemia, for example plasma glucose <3 mmol/l (<55 mg/dl) or requiring hospitalization
• Pulse <40 or >90; Systolic Blood Pressure >160 mmHg; Diastolic Blood Pressure > 100 mmHg