Long-term Study of ASP1941 - A Phase III, Open-Label, Uncontrolled, Monotherapy Study to Assess the Long-term Safety, Tolerability and Efficacy of ASP1941 in Japanese Patients With Type 2 Diabetes Mellitus
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Astellas Pharma Inc
- Enrollment
- 182
- Primary Endpoint
- HbA1c
Study Overview
Brief Summary
The primary objective of this study is to evaluate the long-term safety of ASP1941 in patients with type 2 diabetes mellitus. The second objectives are to compare the efficacy and pharmacokinetics of ASP1941 administered before or after food intake.
Detailed Description
Subject will be randomized into either ASP1941 before meal or ASP1941 after meal groups. Subjects will undergo a screening period before entering the long-term treatment. Dosage may be increased during the treatment period if subjects fulfill increasing criteria and the investigators adjudicate that no impact for subjects safety.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Type 2 diabetic patients for at least 12 weeks
- •HbA1c value between 6.5 and 9.5%
- •Body Mass Index ( BMI )20.0 - 45.0kg/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
- •Proliferative diabetic retinopathy
Arms & Interventions
before meal group
ASP1941 will be administered before meal
Intervention: ipragliflozin (Drug)
after meal group
ASP1941 will be administered after meal
Intervention: ipragliflozin (Drug)
Outcomes
Primary Outcomes
HbA1c
Time Frame: For 52 weeks
Secondary Outcomes
- Fasting plasma glucose(For 52 weeks)
- Fasting serum insulin(For 52 weeks)
- Plasma levels of ASP1941 for population PK analysis(For 52 weeks)
- Safety assessed by adverse events, vital signs laboratory tests and 12-lead ECGs(For 52 weeks)