Lead Sponsor

Astellas Pharma Inc

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

No

•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

•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