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

October 3, 2018 updated by: Mitsubishi Tanabe Pharma Corporation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

138

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
      • Kanto, Japan
        • Reserch site
      • Kinki, Japan
        • Reserch site
      • Tohoku, Japan
        • Reserch 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 to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Canagliflozin + Teneligliptin
Patients receive Canagliflozin for 24 weeks in combination with Teneligliptin.
Drug: Canagliflozin
Other Names:
  • Canaglu, TA-7284
Drug: Teneligliptin
Other Names:
  • Tenelia, MP-513
Placebo Comparator: Placebo + Teneligliptin
Patients receive placebo for 24 weeks in combination with Teneligliptin.
Drug: Placebo
Drug: Teneligliptin
Other Names:
  • Tenelia, MP-513

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c)
Time Frame: Baseline, 24 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 24.
Baseline, 24 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Fasting Plasma Glucose Level
Time Frame: Baseline, 24 Weeks
The change from baseline in fasting plasma glucose level collected at Week 24.
Baseline, 24 Weeks
Percentage Change in Body Weight From Baseline
Time Frame: Baseline, 24 Weeks
The percentage change from baseline in body weight collected at Week 24.
Baseline, 24 Weeks
Change From Baseline in the AUC(0-2h) for Postprandial Plasma Glucose (PPG)
Time Frame: 0, 0.5, 1 and 2 hour postprandial, at Baseline and 24 Weeks
The change from Baseline in AUC(0-2h) for Postprandial Plasma Glucose collected at Week 24.
0, 0.5, 1 and 2 hour postprandial, at Baseline and 24 Weeks
Change From Baseline in 2-hour Postprandial Plasma Glucose Level
Time Frame: 2 Hours Postprandial, at Baseline and 24 Weeks
The change from baseline in 2-hour postprandial plasma glucose level collected at Week 24.
2 Hours Postprandial, at Baseline and 24 Weeks

Collaborators and Investigators

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

Sponsor

Mitsubishi Tanabe Pharma Corporation

Investigators

  • Study Director: Takashi Kadowaki, MD, Tokyo University

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

January 1, 2015

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

January 29, 2015

First Submitted That Met QC Criteria

January 29, 2015

First Posted (Estimate)

February 3, 2015

Study Record Updates

Last Update Posted (Actual)

November 1, 2018

Last Update Submitted That Met QC Criteria

October 3, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MT-2412-J03

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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