A Study to Assess the Safety and Efficacy of ASP1941 in Combination With Dipeptidyl Peptidase-4 (DPP-4) Inhibitor in Type 2 Diabetic Patients

Study Overview
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Brief Summary
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This study is to evaluate long-term safety and efficacy after concomitant administration of ASP1941 and DPP-4 inhibitor in Japanese patients with type 2 diabetes mellitus.

Detailed Description
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This is a 52-week multi-center, open-label, non-comparative study in subjects with type 2 diabetes mellitus who have inadequate glycemic control on a DPP-4 inhibitor alone. Dosage may be increased during the treatment period if subjects fulfill increasing criteria and the investigators adjudicate that no impact for subjects safety.

Official Title
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Phase III Study of ASP1941 - Open-label, Non-comparative Study to Assess the Long-term Safety, Tolerability and Efficacy of ASP1941 in Combination With a Dipeptidyl Peptidase-4 Inhibitor in Japanese Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control With a Dipeptidyl Peptidase-4 Inhibitor Alone

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: ipragliflozin
* Drug: DPP-4 inhibitor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetic patients receiving with DPP-4 inhibitor mono-therapy for at least 4 weeks HbA1c value between 6.5 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ASP group<br>Concomitant administration of ASP1941 and DPP-4 inhibitor | Drug: ipragliflozin<br>* oral<br>* Other names: ASP1941;Drug: DPP-4 inhibitor<br>* oral<br>* Other names: vildagliptin;|

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 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in fasting plasma glucose |  | baseline and 52 weeks | 
| Change from baseline in fasting serum insulin |  | baseline and 52 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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Dipeptidyl peptidase-4 inhibitor, ASP1941, DPP-4 inhibitor, long-term safety, Diabetes mellitus