Type II Diabetes Mellitus
Conditions
Keywords
ASP1941, ipragliflozin, urine glucose, metformin, plasma glucose
Brief summary
To compare the efficacy and safety of ASP1941 + metformin with metformin alone in Asian subjects with type 2 diabetes mellitus.
Interventions
DRUGASP1941
oral
DRUGmetformin
oral, concomitant use
DRUGPlacebo
oral
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
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed as type 2 diabetes mellitus patient at least 12 weeks before the study * Stable diet and exercise program for at least 8 weeks before the study * On a stable dose of at least 1500 mg/day metformin monotherapy or at least 1000 mg/day metformin monotherapy for the subject who can not titrate up to 1500 mg/day due to safety concern of metformin * BMI of 20.0 to 45.0 kg/m2 * A HbA1c value between 7.0 and 10.0% at screening AND does not meet any of discontinuation criteria on fasting plasma glucose
Exclusion criteria
* Type 1 diabetes mellitus * Proliferative diabetic retinopathy * Receiving insulin within 12 weeks prior to the study * History of clinically significant renal disease(s) * Significant dysuria caused by a neurogenic bladder or a benign prostate hypertrophy etc. * Urinary tract infection or genital infection * Continuous use of systemic corticosteroids, immunosuppressants, or loop diuretics * History of cerebrovascular attack, unstable angina, myocardial infarction, angioplasty, serious cardiac diseases within 12 weeks prior to the study * Severe infection, serious trauma, or perioperative subject * Known or suspected hypersensitivity to ASP1941 * History of treatment with ASP1941 * Participated in another clinical study, postmarketing study or medical device study within 12 weeks before the study * Serum creatinine value exceeding the upper limit of normal range * Urinary microalbumin/urinary creatinine ratio \>300 mg/g
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c from baseline to end of treatment | Baseline and up to 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change in fasting plasma glucose level | Baseline and up to 24 weeks |
| Change in fasting serum insulin level | Baseline and up to 24 weeks |
| Change in body weight | Baseline and up to 24 weeks |
| Change in waist circumference | Baseline and up to 24 weeks |
| Safety assessed by the incidence of adverse events, vital signs safety labo-tests and 12-lead ECG | For 24 weeks |
Countries
South Korea, Taiwan
Outcome results
None listed