Status:
COMPLETED
A Study to Assess the Safety and Efficacy of ASP1941 in Combination With Dipeptidyl Peptidase-4 (DPP-4) Inhibitor 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 long-term safety and efficacy after concomitant administration of ASP1941 and DPP-4 inhibitor in Japanese patients with type 2 diabetes mellitus.
Detailed Description
This is a 52-week multi-center, open-label, non-comparative study in subjects with type 2 diabetes mellitus who have inadequate glycemic control on a DPP-4 inhibitor alone. Dosage may be increased dur...
Eligibility Criteria
Inclusion
- Type 2 diabetic patients receiving with DPP-4 inhibitor mono-therapy for at least 4 weeks
- HbA1c value between 6.5 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 :
October 21 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 6 2012
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT01242228
Start Date
October 21 2010
End Date
June 6 2012
Last Update
May 30 2025
Active Locations (6)
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1
Chūbu, Japan
2
Hokkaido, Japan
3
Kansai, Japan
4
Kantou, Japan