A Study to Assess the Efficacy and Safety of ASP1941 in Combination With Pioglitazone in Type 2 Diabetic Patients
Phase 3
Completed
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Registration Number
- NCT01225081
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
This study is to evaluate the efficacy and safety after concomitant administration of ASP1941 and pioglitazone in patients with diabetes mellitus.
- Detailed Description
This study is to evaluate the efficacy (HbA1c change from baseline) and safety of ASP1941 in combination with pioglitazone in subjects with type 2 diabetes mellitus (T2DM) who have inadequate glycemic control with pioglitazone alone. The effects of ASP1941 are compared with those of placebo. Double blind period continues for 24 weeks followed by open period in each patient.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 152
Inclusion Criteria
- Type 2 diabetic patients receiving pioglitazone mono-therapy for at least 4 weeks
- HbA1c value between 7.0 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
- Heart failure patients
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ASP group ipragliflozin ASP1941 and pioglitazone Placebo group Placebo placebo and pioglitazone ASP group Pioglitazone ASP1941 and pioglitazone Placebo group Pioglitazone placebo and pioglitazone
- Primary Outcome Measures
Name Time Method Change from baseline in 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 serum insulin Baseline and for 24 weeks Change from baseline in fasting plasma glucose Baseline and for 24 weeks