Overview

Long-Term Safety Study of MT-2412 in Japanese Patients With Type 2 Diabetes

Status:
Completed
Trial end date:
2016-02-01
Target enrollment:
0
Participant gender:
All
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 diabetes mellitus who are receiving treatment with Teneligliptin and have inadequate glycemic control.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Mitsubishi Tanabe Pharma Corporation
Treatments:
Canagliflozin
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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.