Status:
COMPLETED
A Study to Assess the Efficacy and Safety of ASP1941 in Combination With Metformin 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 metformin in patients with diabetes mellitus.
Detailed Description
This study is to evaluate the efficacy (HbA1c change from baseline) and safety of ASP1941 in combination with metformin in subjects with type 2 diabetes mellitus (T2DM) who have inadequate glycemic co...
Eligibility Criteria
Inclusion
- Type 2 diabetic patients receiving with metformin mono-therapy for at least 6 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
- Estimated GFR \< 60ml/min/1.73m2
- 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 :
May 15 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 28 2011
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT01135433
Start Date
May 15 2010
End Date
November 28 2011
Last Update
May 30 2025
Active Locations (7)
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1
Chugoku, Japan
2
Chūbu, Japan
3
Hokkaido, Japan
4
Kansai, Japan