A Study to Evaluate the Effect of ASP1941 in Adult Patients With Type 2 Diabetes Mellitus

Launched by ASTELLAS PHARMA INC · Feb 18, 2010

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Eligibility criteria

• Inclusion Criteria:
• • Subject has been diagnosed with type 2 diabetes
• • Subject has a HbA1c value between 6.8 and 9.5%
• • Subject has never, is not currently taking anti-diabetic medication OR is receiving a single anti- diabetic agent or low-doses two anti-diabetic medications and is willing to discontinue them during the study
• • Subject is on a stable diet and exercise program
• • Female subject is not pregnant and agrees to use an acceptable form of contraception throughout the duration of the study
• Exclusion Criteria:
• • Subject has type 1 diabetes mellitus
• • Subject is using insulin therapy
• • Subject has a serum creatinine higher than upper limit of normal
• • Subject has an ALT and/or AST value higher than 3 times upper limit of normal or a total bilirubin value more than 2 times upper limit of normal
• • Subject has persistent, uncontrolled severe hypertension as indicated by a
• • systolic blood pressure \>180 mmHg or a diastolic blood pressure of
• • \>110mmHg
• • Subject has had significant cardiovascular disease such as myocardial infarction or a vascular intervention (e.g., angioplasty or stent) in the last 3 months
• • Subject is known to have hepatitis or be a carrier of hepatitis B surface
• • antigen, hepatitis C virus antibody or is known positive for HIV1 and/or
• • HIV2
• • Subject has a history of lactic acidosis
• • Subject has a history of drug and alcohol abuse/dependency within last 12
• • months
• • Subject has had a malignancy in the last 5 years, except for successfully
• • treated basal or squamous cell carcinoma of the skin or of the cervix
• • Subject has a symptomatic urinary tract infection or genital infection
• • Female subject is lactating
• • Subject has an unstable medical or psychiatric illness