Status:
COMPLETED
A Study to Assess the Efficacy and Safety of ASP1941 in Combination With Pioglitazone 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 pioglitazone 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 pioglitazone in subjects with type 2 diabetes mellitus (T2DM) who have inadequate glycemic...
Eligibility Criteria
Inclusion
- Type 2 diabetic patients receiving pioglitazone 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
- Heart failure patients
Key Trial Info
Start Date :
September 15 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 28 2012
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT01225081
Start Date
September 15 2010
End Date
April 28 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