A Study to Assess the Efficacy and Safety of ASP1941 in Combination With Sulfonylurea in Type 2 Diabetic Patients

Study Overview
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Brief Summary
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This study is to evaluate the efficacy and safety after concomitant administration of ASP1941 and sulfonylurea in patients with diabetes mellitus.

Detailed Description
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This study is to evaluate the efficacy and safety of ASP1941 in combination with sulfonylurea in subjects with type 2 diabetes mellitus (T2DM) who have inadequate glycemic control with sulfonylurea alone. The effects of ASP1941 are compared with those of placebo. Double blind period continues for 24 weeks followed by open period in each patient.

Official Title
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A Phase III Study to Assess the Efficacy, Safety and Tolerability of ASP1941 in Combination With Sulfonylurea in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Sulfonylurea Alone

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Device: ipragliflozin
* Drug: Placebo
* Drug: Sulfonylurea


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetic patients receiving with sulfonylurea mono-therapy for at least 4 weeks HbA1c value between 7.0 and 9.5% Body Mass Index (BMI) 20.0 - 45.0 kg/m2 Exclusion Criteria: Type 1 diabetes mellitus patients Serum creatinine > upper limit of normal Proteinuria (albumin/creatinine ratio > 300mg/g) Dysuria and/or urinary tract infection, genital infection Significant renal, hepatic or cardiovascular diseases Severe gastrointestinal diseases

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: ASP group<br>ASP1941 and sulfonylurea | Device: ipragliflozin<br>* oral<br>* Other names: ASP1941;Drug: Sulfonylurea<br>* oral<br>* Other names: Glimepiride;|
| Placebo Comparator: Placebo group<br>placebo and sulfonylurea | Drug: Placebo<br>* oral<br>Drug: Sulfonylurea<br>* oral<br>* Other names: Glimepiride;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in HbA1c |  | Baseline and for 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in fasting plasma glucose |  | Baseline and for 24 weeks | 
| Change from baseline in fasting serum insulin |  | Baseline and for 24 weeks | 
| Safety as reflected by adverse events, routine safety laboratories, vital signs, physical examinations and 12-lead electrocardiograms (ECGs) |  | for 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes mellitus, sulfonylurea, ASP1941