Status:
COMPLETED
A Study to Assess the Efficacy and Safety of ASP1941 in Combination With Sulfonylurea in Type 2 Diabetic Patients
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
This study is to evaluate the efficacy and safety after concomitant administration of ASP1941 and sulfonylurea in patients with diabetes mellitus.
Detailed Description
This study is to evaluate the efficacy and safety of ASP1941 in combination with sulfonylurea in subjects with type 2 diabetes mellitus (T2DM) who have inadequate glycemic control with sulfonylurea al...
Eligibility Criteria
Inclusion
- Type 2 diabetic patients receiving with sulfonylurea mono-therapy for at least 4 weeks
- HbA1c value between 7.0 and 9.5%
- Body Mass Index (BMI) 20.0 - 45.0 kg/m2
Exclusion
- 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
Key Trial Info
Start Date :
September 17 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 25 2012
Estimated Enrollment :
243 Patients enrolled
Trial Details
Trial ID
NCT01242215
Start Date
September 17 2010
End Date
April 25 2012
Last Update
May 30 2025
Active Locations (7)
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1
Chugoku, Japan
2
Chūbu, Japan
3
Hokkaido, Japan
4
Kansai, Japan