A Study to Assess the Safety and Efficacy of ASP1941 in Combination With α-glucosidase Inhibitor in Type 2 Diabetic Patients
Phase 3
Completed
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Drug: alpha glucosidase inhibitor
- Registration Number
- NCT01242202
- Lead Sponsor
- Astellas Pharma Inc
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 113
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ASP group alpha glucosidase inhibitor Concomitant administration of ASP1941 and α- glucosidase inhibitor ASP group ipragliflozin Concomitant administration of ASP1941 and α- glucosidase inhibitor
- Primary Outcome Measures
Name Time Method Change from baseline in HbA1c baseline and 52 weeks
- Secondary Outcome Measures
Name Time Method 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 Change from baseline in fasting plasma glucose baseline and 52 weeks