NCT00621868CompletedPhase 2
ASP1941 Phase II Clinical Study - A Double-blind, Placebo-controlled, Parallel-group, Dose-response Study in Patients With Type 2 Diabetes Mellitus
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Astellas Pharma Inc
- Enrollment
- 361
- Primary Endpoint
- HbA1c level
Study Overview
Brief Summary
The objective of this study is to evaluate the efficacy, safety and pharmacokinetics of ASP1941 in male and female patients with type 2 diabetes mellitus
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 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Established diagnosis of type 2 diabetes mellitus
- •Fasting serum C-peptide level > 0.6 ng/mL
- •HbA1c between 7.0 and 10.0%
- •Body Mass Index between 20 and 45 kg/m2
Exclusion Criteria
- •Serum creatinine > upper limit of normal
- •Proteinuria (albumin/creatinine ratio > 300 mg/g)
- •Dysuria and/or urinary tract infection
- •Significant renal, hepatic or cardiovascular diseases
- •Hypertension
- •Severe gastrointestinal diseases
Arms & Interventions
1
Experimental
Lowest dose
Intervention: ipragliflozin (Drug)
2
Experimental
Low-middle dose
Intervention: ipragliflozin (Drug)
3
Experimental
High-middle dose
Intervention: ipragliflozin (Drug)
4
Experimental
Highest dose
Intervention: ipragliflozin (Drug)
5
Placebo Comparator
placebo
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
HbA1c level
Time Frame: 12 weeks
Secondary Outcomes
- Blood glucose level(12 Weeks)
- Safety(12 Weeks)
Investigators
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