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

December 15, 2025 updated by: Tanabe Pharma Corporation

Long-term Administration Study of MT-2412 in Patients With Type 2 Diabetes Mellitus

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

153

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Chugoku, Japan
        • Research Site
      • Chūbu, Japan
        • Research Site
      • Hokkaido, Japan
        • Research Site
      • Kanto, Japan
        • Research Site
      • Kyushu, Japan
        • Research Site
      • Tōhoku, Japan
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Teneligliptin/Canagliflozin
Patients receive Teneligliptin and Canagliflozin once daily for 52 weeks.
Drug: Teneligliptin/Canagliflozin
Co-administration of Teneligliptin and Canagliflozin orally once daily for 52 weeks.
Other Names:
  • MP-513
  • Tenelia
  • Canaglu
  • TA-7284

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With Adverse Events
Time Frame: 52 Weeks
52 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c)
Time Frame: Baseline, 52 Weeks
The change from baseline in percentage of HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 52.
Baseline, 52 Weeks
Change From Baseline in Fasting Plasma Glucose Level
Time Frame: Baseline, 52 Weeks
The change from baseline in fasting plasma glucose level collected at Week 52.
Baseline, 52 Weeks
Percentage Change in Body Weight From Baseline
Time Frame: Baseline, 52 Weeks
The percentage change from baseline in body weight collected at Week 52.
Baseline, 52 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanabe Pharma Corporation

Investigators

  • Study Director: Takashi Kadowaki, MD, Tokyo University
  • Study Director: Nobuya Inagaki, MD, Kyoto University
  • Study Director: Kazuoki Kondo, MD, Tanabe Pharma Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

August 19, 2014

First Submitted That Met QC Criteria

August 19, 2014

First Posted (Estimated)

August 20, 2014

Study Record Updates

Last Update Posted (Estimated)

January 7, 2026

Last Update Submitted That Met QC Criteria

December 15, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MT-2412-J01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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