A Phase III Study to Assess the Efficacy, Safety and Tolerability of ASP1941 in Combination With Sulfonylurea in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Sulfonylurea Alone
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Astellas Pharma Inc
- Enrollment
- 243
- Primary Endpoint
- Change from baseline in HbA1c
Study Overview
Brief Summary
This study is to evaluate the efficacy and safety after concomitant administration of ASP1941 and sulfonylurea in patients with diabetes mellitus.
Detailed Description
This study is to evaluate the efficacy and safety of ASP1941 in combination with sulfonylurea in subjects with type 2 diabetes mellitus (T2DM) who have inadequate glycemic control with sulfonylurea 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Type 2 diabetic patients receiving with sulfonylurea 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
Arms & Interventions
ASP group
ASP1941 and sulfonylurea
Intervention: ipragliflozin (Device)
ASP group
ASP1941 and sulfonylurea
Intervention: Sulfonylurea (Drug)
Placebo group
placebo and sulfonylurea
Intervention: Placebo (Drug)
Placebo group
placebo and sulfonylurea
Intervention: Sulfonylurea (Drug)
Outcomes
Primary Outcomes
Change from baseline in HbA1c
Time Frame: Baseline and for 24 weeks
Secondary Outcomes
- Change from baseline in fasting plasma glucose(Baseline and for 24 weeks)
- Change from baseline in fasting serum insulin(Baseline and for 24 weeks)
- Safety as reflected by adverse events, routine safety laboratories, vital signs, physical examinations and 12-lead electrocardiograms (ECGs)(for 52 weeks)