Status:
TERMINATED
A Study to Assess the Efficacy and Safety of ASP1941 in Asian Subjects With Type 2 Diabetes Mellitus
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Type II Diabetes Mellitus
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess the efficacy of ASP1941 based on the changes in HbA1C as well as its safety in Asian subjects with type 2 diabetes mellitus.
Detailed Description
This is a multi-center, active-controlled, double-blind, double-dummy, parallel-group comparative study. After a screening period followed by a placebo run-in period under the single-blind condition, ...
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 6 weeks before the study
- for the hypoglycemic agent non-naïve subject, subject has been receiving a single hypoglycemic agent or low-dose of a dual combination therapy
- BMI of 20.0 to 45.0 kg/m2
- for the hypoglycemic agent non-naïve subject, subject has a HbA1c value between 6.8 and 10.0% at screening AND has a HbA1c value between 7.0 and 10.0%, inclusive, at run-in period
- for the hypoglycemic agent naïve subject, subject has a HbA1c value between 7.0 and 10.0%, inclusive, at run-in period
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, acarbose or other alpha-GI
- 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 :
April 23 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 19 2012
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT01514838
Start Date
April 23 2012
End Date
October 19 2012
Last Update
November 12 2024
Active Locations (15)
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1
Busan, South Korea
2
Daegu, South Korea
3
Daejeon, South Korea
4
Gwangju, South Korea