A Study to Assess the Safety and Efficacy of ASP1941 in Combination With α-glucosidase Inhibitor in Type 2 Diabetic Patients

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

Detailed Description
-----------------
This is a 52-week multi-center study in subjects with type 2 diabetes mellitus who have inadequate glycemic control on an α-Glucosidase 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
-----------------
Phase III Study of ASP1941 - Open-label, Non-comparative Study to Assess the Long-term Safety, Tolerability and Efficacy of ASP1941 in Combination With an α-Glucosidase Inhibitor in Japanese Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control With an α-Glucosidase Inhibitor Alone

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: ipragliflozin
* Drug: alpha glucosidase inhibitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetic patients receiving with α-glucosidase 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
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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 α- glucosidase inhibitor | Drug: ipragliflozin<br>* oral<br>* Other names: ASP1941;Drug: alpha glucosidase inhibitor<br>* oral<br>* Other names: Voglibose;|

What is the study measuring?
-----------------
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
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes mellitus, alpha glucosidase inhibitor, ASP1941, long-term safety