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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Teneligliptin/Canagliflozin
Sponsored by
Mitsubishi Tanabe Pharma Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring MT-2412, MP-513, TA-7284, Teneligliptin, Canagliflozin

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Research site
  • Research site
  • Research site
  • Research site
  • Research site
  • Research site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Teneligliptin/Canagliflozin

Arm Description

Patients receive Teneligliptin and Canagliflozin once daily for 52 weeks.

Outcomes

Primary Outcome Measures

Number of Participants With Adverse Events

Secondary Outcome Measures

Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c)
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.
Change From Baseline in Fasting Plasma Glucose Level
The change from baseline in fasting plasma glucose level collected at Week 52.
Percentage Change in Body Weight From Baseline
The percentage change from baseline in body weight collected at Week 52.

Full Information

First Posted
August 19, 2014
Last Updated
October 3, 2018
Sponsor
Mitsubishi Tanabe Pharma Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02220907
Brief Title
Long-Term Safety Study of MT-2412 in Japanese Patients With Type 2 Diabetes
Official Title
Long-term Administration Study of MT-2412 in Patients With Type 2 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mitsubishi Tanabe Pharma Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
MT-2412, MP-513, TA-7284, Teneligliptin, Canagliflozin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
153 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Teneligliptin/Canagliflozin
Arm Type
Experimental
Arm Description
Patients receive Teneligliptin and Canagliflozin once daily for 52 weeks.
Intervention Type
Drug
Intervention Name(s)
Teneligliptin/Canagliflozin
Other Intervention Name(s)
Tenelia, MP-513, Canaglu, TA-7284
Intervention Description
Co-administration of Teneligliptin and Canagliflozin orally once daily for 52 weeks.
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events
Time Frame
52 Weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c)
Description
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.
Time Frame
Baseline, 52 Weeks
Title
Change From Baseline in Fasting Plasma Glucose Level
Description
The change from baseline in fasting plasma glucose level collected at Week 52.
Time Frame
Baseline, 52 Weeks
Title
Percentage Change in Body Weight From Baseline
Description
The percentage change from baseline in body weight collected at Week 52.
Time Frame
Baseline, 52 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Takashi Kadowaki, MD
Organizational Affiliation
Tokyo University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Nobuya Inagaki, MD
Organizational Affiliation
Kyoto University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kazuoki Kondo, MD
Organizational Affiliation
Mitsubishi Tanabe Pharma Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Research site
City
Chubu
Country
Japan
Facility Name
Research site
City
Chugoku
Country
Japan
Facility Name
Research site
City
Hokkaido
Country
Japan
Facility Name
Research site
City
Kanto
Country
Japan
Facility Name
Research site
City
Kyushu
Country
Japan
Facility Name
Research site
City
Tohoku
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
28608617
Citation
Kadowaki T, Inagaki N, Kondo K, Nishimura K, Kaneko G, Maruyama N, Nakanishi N, Watanabe Y, Gouda M, Iijima H. Long-term safety and efficacy of canagliflozin as add-on therapy to teneligliptin in Japanese patients with type 2 diabetes. Diabetes Obes Metab. 2018 Jan;20(1):77-84. doi: 10.1111/dom.13038. Epub 2017 Jul 31.
Results Reference
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Long-Term Safety Study of MT-2412 in Japanese Patients With Type 2 Diabetes

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