Diabetes Mellitus, Type 2
Conditions
Keywords
ASP1941, Metformin, Type 2 diabetes, diabetes
Brief 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.
Interventions
DRUGipragliflozin
oral tablet
DRUGMetformin
oral tablet
DRUGPlacebo
oral tablet
Sponsors
Astellas Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change from baseline in Hemoglobin A1c (HbA1c) | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Mean change from baseline in fasting plasma glucose (FPG) | 12 weeks |
| Proportion of subjects achieving target goal of HbA1c <7.0% | 12 weeks |
| Proportion of subjects achieving target goal of HbA1c <6.5% | 12 weeks |
Countries
Colombia, India, Mexico, Philippines, United States
Outcome results
None listed