Confirmatory Study of MT-2412 in Japanese Patients With Type 2 Diabetes (Add-on Study of Teneligliptin)

Confirmatory Study of MT-2412 in Japanese Patients With Type 2 Diabetes (Add-on Study of Teneligliptin in Patients With Inadequate Glycemic Control on Canagliflozin)

The purpose of this study is to evaluate the efficacy and safety of co-administration of Canagliflozin (TA-7284) and Teneligliptin (MP-513) once daily for 24 weeks in Japanese patients with Type 2 diabetes mellitus who are receiving treatment with Canagliflozin and have inadequate glycemic control.

Inclusion Criteria:

• Men or women who are 20 - 75 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 8 weeks before run-in 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.