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

• Status: Completed
• Trial end date: 2011-04-11
• Target enrollment: 0
• Participant gender: All

Summary

Evaluate the efficacy, safety, and tolerability of multiple doses of ASP1941 compared to placebo over 12 weeks of therapy in adult patients with type 2 diabetes mellitus.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Ipragliflozin; Metformin

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