Status:
COMPLETED
A Study to Assess the Efficacy and Safety of ASP1941 in Combination With Metformin in Asian Diabetes Patients
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Type II Diabetes Mellitus
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
To compare the efficacy and safety of ASP1941 + metformin with metformin alone in Asian subjects with type 2 diabetes mellitus.
Eligibility Criteria
Inclusion
- Diagnosed as type 2 diabetes mellitus patient at least 12 weeks before the study
- Stable diet and exercise program for at least 8 weeks before the study
- On a stable dose of at least 1500 mg/day metformin monotherapy or at least 1000 mg/day metformin monotherapy for the subject who can not titrate up to 1500 mg/day due to safety concern of metformin
- BMI of 20.0 to 45.0 kg/m2
- A HbA1c value between 7.0 and 10.0% at screening AND does not meet any of discontinuation criteria on fasting plasma glucose
Exclusion
- Type 1 diabetes mellitus
- Proliferative diabetic retinopathy
- Receiving insulin within 12 weeks prior to the study
- History of clinically significant renal disease(s)
- Significant dysuria caused by a neurogenic bladder or a benign prostate hypertrophy etc.
- Urinary tract infection or genital infection
- Continuous use of systemic corticosteroids, immunosuppressants, or loop diuretics
- History of cerebrovascular attack, unstable angina, myocardial infarction, angioplasty, serious cardiac diseases within 12 weeks prior to the study
- Severe infection, serious trauma, or perioperative subject
- Known or suspected hypersensitivity to ASP1941
- History of treatment with ASP1941
- Participated in another clinical study, postmarketing study or medical device study within 12 weeks before the study
- Serum creatinine value exceeding the upper limit of normal range
- Urinary microalbumin/urinary creatinine ratio \>300 mg/g
Key Trial Info
Start Date :
November 28 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 14 2013
Estimated Enrollment :
171 Patients enrolled
Trial Details
Trial ID
NCT01505426
Start Date
November 28 2011
End Date
January 14 2013
Last Update
November 12 2024
Active Locations (12)
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1
Busan, South Korea
2
Daegu, South Korea
3
Daejeon, South Korea
4
Gwangju, South Korea