None listed
Conditions
Interventions
Intervention1: ASP 1941: Drug(including placebo), Oral tablet (Lowest dose, low dose, high dose, highest dose)
Control Intervention1: Metformin: Active Comparator, Oral tablet
Sponsors
Astellas Pharma Inc
Eligibility
Inclusion 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
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 >110 mmHg - 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 H1V1 and/or HIV2 - Subject has a history of lactic acidosis - Subject has a history of drug and alcohol abuse/dependency within last lst 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 medicalor psychiatric illness
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change from baseline in Hemoglobin A1c(HbA1c)Timepoint: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Mean change from baseline in fasting plasma glucose (FPG)Timepoint: 12 weeks;2) Proportion of subjects achieving target goal of HbA1c less than 7.0%Timepoint: 12 weeks | — |
Countries
Georgia, India, Mexico, Other, Philippines, United States of America
Contacts
Public ContactSheetal Suresh
Outcome results
None listed