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

Tanabe Pharma Corporation

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Placebo; Drug: Canagliflozin; Drug: Teneligliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02354235

MT-2412-J03

Details and patient eligibility

About

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

Enrollment: 138 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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138 participants in 2 patient groups, including a placebo group

Canagliflozin + Teneligliptin

Experimental group

Description:

Patients receive Canagliflozin for 24 weeks in combination with Teneligliptin.

Treatment:

Drug: Teneligliptin

Drug: Canagliflozin

Placebo + Teneligliptin

Placebo Comparator group

Description:

Patients receive placebo for 24 weeks in combination with Teneligliptin.

Treatment:

Drug: Teneligliptin

Drug: Placebo