Status:
COMPLETED
Long-Term Safety Study of MT-2412 in Japanese Patients With Type 2 Diabetes
Lead Sponsor:
Tanabe Pharma Corporation
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of co-administration of Teneligliptin (MP-513) and Canagliflozin (TA-7284) once daily for 52 weeks in Japanese patients with Type 2 dia...
Eligibility Criteria
Inclusion
- Men or women age ≥20 years old
- HbA1c of ≥7.0% and \<10.5%
- FPG of ≤ 270 mg/dL
- Patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before treatment period
Exclusion
- Patients with type I diabetes, diabetes mellitus resulting from pancreatic disorder, or secondary diabetes
- Patients with serious diabetic complications
- Patients with hereditary glucose-galactose malabsorption or primary renal glucosuria
- Patients with Class III/IV heart failure symptoms according to New York Heart Association (NYHA) functional classification
- Patients with severe hepatic disorder or severe renal disorder.
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT02220907
Start Date
August 1 2014
End Date
February 1 2016
Last Update
January 7 2026
Active Locations (6)
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1
Research site
Chugoku, Japan
2
Research site
Chūbu, Japan
3
Research site
Hokkaido, Japan
4
Research site
Kanto, Japan