A Study to Evaluate the Effect of ASP1941 in Adult Patients With Type 2 Diabetes Mellitus
Status: | Completed |
---|---|
Conditions: | Diabetes, Diabetes |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 11/23/2017 |
Start Date: | March 3, 2010 |
End Date: | April 11, 2011 |
A Phase 2, Double-Blind, Randomized, Placebo and Active-Controlled Dose-Finding Study to Assess the Efficacy, Safety and Tolerability of Multiple Oral Doses of ASP1941 in Subjects With Type 2 Diabetes Mellitus
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.
placebo over 12 weeks of therapy in adult patients with type 2 diabetes mellitus.
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
We found this trial at
38
sites
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