Lead Sponsor

Astellas Pharma Inc

Age

45 - 80 years

Sex

ALL

Healthy Volunteers

Yes

•Patient with stable type 2 diabetes mellitus or healthy subject
•Subject must have pre-dose estimated Glomerular filtration rate (GFR) values (Modification of diet in renal disease (MDRD) method) at screening of:
•* \>90 (normal renal function)
•* 60-90 (mild renal impairment)
•* 30-60 (moderate renal impairment)
•* 15-30 (severe renal impairment)
•BMI between 25.0-40.0 kg/m2, inclusive
•Fasted plasma glucose (FPG) \<11.5 mmol/l (type 2 DM patients) or \>5.6 mmol/l (Healthy volunteers)

•Patients with Type 1 diabetes
•Pulse \<40 or \>90; SBP \>160 mmHg; DBP \> 100 mmHg
•T2DM patients who are not on a stable regimen for their current medication (1 month or 5 half lives, whichever is longer) to control their disease
•Healthy Volunteers: Any of the liver function tests above the upper limit of normal
•T2DM: The liver function tests should be within the following ranges:
•* AST/ALT: \<2 x ULN
•* Bilirubin: \<1.5 x ULN
•* Alk Phos: \< 1.5 x ULN
•Patients with renal impairment who have a history of a clinically significant illness (other than renal diseases and T2DM and associated clinical symptoms), medical condition, or laboratory abnormality within 3 months prior to screening
•Patients with renal impairment who have not been on a stable dose of concomitant medications for at least 2 weeks for at least 2 weeks (or 5 halflives, whichever is longer) and/or for whom dose changes are likely to occur during the study
•Patients with T2DM treated with a diet only
•T2DM patients with recent evidence (e.g within the last 6 months) of severe hypoglycemia, for example plasma glucose \< 3mmol/l (\<55 mg/dl), help from others to resolve the hypo or requiring hospitalization
•T2DM patients with a Hemoglobin value \< 9 g/dl (5.6 mmol/l)