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.