Type II Diabetes Mellitus
Conditions
Keywords
urine glucose, ipragliflozin, plasma glucose, ASP1941
Brief summary
The purpose of this study is to assess the efficacy of ASP1941 based on the changes in HbA1C as well as its safety in Asian subjects with type 2 diabetes mellitus.
Detailed description
This is a multi-center, active-controlled, double-blind, double-dummy, parallel-group comparative study. After a screening period followed by a placebo run-in period under the single-blind condition, subjects will be randomized to either the ASP1941 or the acarbose group. Subjects will take the study drug under the double-blind condition in the treatment period. After completion of the study drug administration, a follow-up period will be provided.
Interventions
DRUGASP1941
oral
DRUGacarbose
oral
DRUGPlacebo
oral, used only during placebo run-in period
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 6 weeks before the study * for the hypoglycemic agent non-naïve subject, subject has been receiving a single hypoglycemic agent or low-dose of a dual combination therapy * BMI of 20.0 to 45.0 kg/m2 * for the hypoglycemic agent non-naïve subject, subject has a HbA1c value between 6.8 and 10.0% at screening AND has a HbA1c value between 7.0 and 10.0%, inclusive, at run-in period * for the hypoglycemic agent naïve subject, subject has a HbA1c value between 7.0 and 10.0%, inclusive, at run-in period
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, acarbose or other alpha-GI * 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 body 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