A Study to Assess Safety and Efficacy of ASP1941 in Combination With Nateglinide in Type 2 Diabetic Patients
- Registration Number
- NCT01316107
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
This study is to evaluate long-term safety and efficacy after concomitant administration of ASP1941 and Nateglinide inhibitor in Japanese patients with type 2 diabetes mellitus.
- Detailed Description
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 Nateglinide alone more than 4 weeks. 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
- 122
Inclusion Criteria
- Type 2 diabetic patients receiving with Nateglinide 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 ipragliflozin Concomitant administration of ASP1941 and nateglinide ASP group nateglinide Concomitant administration of ASP1941 and nateglinide
- Primary Outcome Measures
Name Time Method change from baseline in hemoglobin A1c (HbA1c) baseline and for 24 weeks
- Secondary Outcome Measures
Name Time Method 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 for 24 weeks change from baseline in fasting serum insulin baseline and for 24 weeks