Lead Sponsor

AstraZeneca

Collaborators

Age

18 - 77 years

Sex

ALL

Healthy Volunteers

No

•Treatment naive males and females, \>= 18 years old and
•\<= 77 years old, with type 2 diabetes mellitus
•Subjects must have central laboratory pre-randomization hemoglobin A1C \>= 7.5 and \<= 12.0%
•C-peptide \>= 1.0 ng/mL (0.34 nmol/L)
•Body Mass Index \<= 45 kg/m2
•Must be able to perform self monitoring of blood glucose

•aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \>3X\*upper limit of normal (ULN)
•Serum Total bilirubin \>2 mg/dL (34.2 µmol/L)
•Creatinine kinase \>3\*ULN
•Serum creatinine \>= 1.50 mg/dL (133 µmol/L) for male subjects, \>= 1.40 mg/dL (124 µmol/L) for female subjects
•Calcium value outside of the central laboratory normal reference range
•Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases
•Urine albumin:creatinine ratio (UACR) \>1800 mg/g (203.4 mg/mmol Cr)
•Severe uncontrolled hypertension defined as systolic blood pressure (SBP) \>=180 mmHg and/or diastolic blood pressure (DBP) \>=110 mmHg
•Hemoglobin \>=11.0 g/dL (110 g/L) for men; hemoglobin \>=10.0 g/dL (100 g/L) for women
•Positive for hepatitis B surface antigen
•Positive for anti-hepatitis C virus antibody
•History of diabetes insipidus
•History of diabetic ketoacidosis or hyperosmolar nonketotic coma
•Symptoms of poorly controlled diabetes that would preclude participation in this trial