A Study to Assess the Efficacy and Safety of ASP1941 in Asian Subjects With Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase III, Double-Blind, Randomized, Active Controlled, Monotherapy Study to Assess the Efficacy and Safety of ASP1941 in Asian Subjects With Type 2 Diabetes Mellitus

Conditions
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Type II Diabetes Mellitus

Intervention / Treatment
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* Drug: ASP1941
* Drug: acarbose
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1941 group<br>Once daily over a 24-week treatment period | Drug: ASP1941<br>* oral<br>* Other names: ipragliflozin;Drug: Placebo<br>* oral, used only during placebo run-in period<br>|
| Active Comparator: acarbose group<br>Once daily over a 24-week treatment period | Drug: acarbose<br>* oral<br>Drug: Placebo<br>* oral, used only during placebo run-in period<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c from baseline to end of treatment |  | Baseline and up to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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urine glucose, ipragliflozin, plasma glucose, ASP1941