A Study to Assess the Efficacy and Safety of ASP1941 in Combination With Metformin in Asian Diabetes Patients

Study Overview
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Brief Summary
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To compare the efficacy and safety of ASP1941 + metformin with metformin alone in Asian subjects with type 2 diabetes mellitus.

Official Title
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A Phase III, Double-Blind, Randomized, Placebo-Controlled Study to Assess the Efficacy and Safety of ASP1941 in Combination With Metformin in Asian Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone

Conditions
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Type II Diabetes Mellitus

Intervention / Treatment
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* Drug: ASP1941
* Drug: metformin
* 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 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

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: ASP1941 group<br>ASP1941 + metformin | Drug: ASP1941<br>* oral<br>* Other names: ipragliflozin;Drug: metformin<br>* oral, concomitant use<br>|
| Placebo Comparator: placebo group<br>placebo + metformin | Drug: metformin<br>* oral, concomitant use<br>Drug: Placebo<br>* oral<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 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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ASP1941, ipragliflozin, urine glucose, metformin, plasma glucose