A Study to Assess the Efficacy and Safety of ASP1941 in Japanese Type 2 Diabetes Patients
- Registration Number
- NCT01057628
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
This study is to compare the efficacy and safety of ASP1941 with placebo in Japanese patients with type 2 diabetes mellitus.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 130
Inclusion Criteria
- Type 2 diabetic patients for at least 12 weeks
- HbA1c value between 7.0 and 10.0%
- Body Mass Index (BMI) 20.0 - 45.0 kg/m2
- Investigator adjudicates that a subject is able to discontinue currently taking hypoglycemic agents safely during treatment
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo group placebo oral ASP1941 group ipragliflozin oral
- Primary Outcome Measures
Name Time Method change from baseline in HbA1c 16 weeks
- Secondary Outcome Measures
Name Time Method change from baseline in fasting plasma glucose 16 weeks change from baseline in fasting serum insulin 16 weeks safety as reflected by adverse events, routine safety laboratories, vital signs, physical examinations and 12-lead electrocardiograms (ECGs) During treatment