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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-02-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Teneligliptin + Canagliflozin

Patients receive Teneligliptin for 24 weeks in combination with Canagliflozin.

Group Type EXPERIMENTAL

Canagliflozin

Intervention Type DRUG

Teneligliptin

Intervention Type DRUG

Placebo + Canagliflozin

Patients receive placebo for 24 weeks in combination with Canagliflozin.

Group Type PLACEBO_COMPARATOR

Canagliflozin

Intervention Type DRUG

Placebo

Intervention Type DRUG

Interventions

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Canagliflozin

Intervention Type DRUG

Teneligliptin

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Canaglu, TA-7284 Tenelia, MP-513

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No