NCT01071850
Completed
Phase 2
A Phase 2, Double-Blind, Randomized, Placebo and Active-Controlled Dose-Finding Study to Assess the Efficacy, Safety and Tolerability of Multiple Oral Doses of ASP1941 in Patients With Type 2 Diabetes Mellitus
ConditionsDiabetes Mellitus, Type 2
Overview
- Phase
- Phase 2
- Intervention
- ipragliflozin
- Conditions
- Diabetes Mellitus, Type 2
- Sponsor
- Astellas Pharma Inc
- Enrollment
- 412
- Locations
- 59
- Primary Endpoint
- Mean change from baseline in Hemoglobin A1c (HbA1c)
- Status
- Completed
- Last Updated
- 11 months ago
Overview
Brief Summary
Evaluate the efficacy, safety, and tolerability of multiple doses of ASP1941 compared to placebo over 12 weeks of therapy in adult patients with type 2 diabetes mellitus.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject has been diagnosed with type 2 diabetes
- •Subject has a HbA1c value between 6.8 and 9.5%
- •Subject has never, is not currently taking anti-diabetic medication OR is receiving a single anti- diabetic agent or low-doses two anti-diabetic medications and is willing to discontinue them during the study
- •Subject is on a stable diet and exercise program
- •Female subject is not pregnant and agrees to use an acceptable form of contraception throughout the duration of the study
Exclusion Criteria
- •Subject has type 1 diabetes mellitus
- •Subject is using insulin therapy
- •Subject has a serum creatinine higher than upper limit of normal
- •Subject has an ALT and/or AST value higher than 3 times upper limit of normal or a total bilirubin value more than 2 times upper limit of normal
- •Subject has persistent, uncontrolled severe hypertension as indicated by a
- •systolic blood pressure \>180 mmHg or a diastolic blood pressure of
- •Subject has had significant cardiovascular disease such as myocardial infarction or a vascular intervention (e.g., angioplasty or stent) in the last 3 months
- •Subject is known to have hepatitis or be a carrier of hepatitis B surface
- •antigen, hepatitis C virus antibody or is known positive for HIV1 and/or
- •Subject has a history of lactic acidosis
Arms & Interventions
ASP1941 highest dose
oral tablet
Intervention: ipragliflozin
Metformin
oral tablet
Intervention: Metformin
Placebo
oral tablet
Intervention: Placebo
ASP1941 lowest dose
oral tablet
Intervention: ipragliflozin
ASP1941 low dose
oral tablet
Intervention: ipragliflozin
ASP1941 high dose
oral tablet
Intervention: ipragliflozin
Outcomes
Primary Outcomes
Mean change from baseline in Hemoglobin A1c (HbA1c)
Time Frame: 12 weeks
Secondary Outcomes
- Proportion of subjects achieving target goal of HbA1c <7.0%(12 weeks)
- Proportion of subjects achieving target goal of HbA1c <6.5%(12 weeks)
- Mean change from baseline in fasting plasma glucose (FPG)(12 weeks)
Study Sites (59)
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