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

Tanabe Pharma Corporation

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Teneligliptin/Canagliflozin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02220907

MT-2412-J01

Details and patient eligibility

About

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.

Enrollment: 153 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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153 participants in 1 patient group

Teneligliptin/Canagliflozin

Experimental group

Description:

Patients receive Teneligliptin and Canagliflozin once daily for 52 weeks.

Treatment:

Drug: Teneligliptin/Canagliflozin