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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Teneligliptin
Canagliflozin
Placebo
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 - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Reserch site
  • Reserch site
  • Reserch site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Canagliflozin + Teneligliptin

Placebo + Teneligliptin

Arm Description

Patients receive Canagliflozin for 24 weeks in combination with Teneligliptin.

Patients receive placebo for 24 weeks in combination with Teneligliptin.

Outcomes

Primary 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 24.

Secondary Outcome Measures

Change From Baseline in Fasting Plasma Glucose Level
The change from baseline in fasting plasma glucose level collected at Week 24.
Percentage Change in Body Weight From Baseline
The percentage change from baseline in body weight collected at Week 24.
Change From Baseline in the AUC(0-2h) for Postprandial Plasma Glucose (PPG)
The change from Baseline in AUC(0-2h) for Postprandial Plasma Glucose collected at Week 24.
Change From Baseline in 2-hour Postprandial Plasma Glucose Level
The change from baseline in 2-hour postprandial plasma glucose level collected at Week 24.

Full Information

First Posted
January 29, 2015
Last Updated
October 3, 2018
Sponsor
Mitsubishi Tanabe Pharma Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02354235
Brief Title
Confirmatory Study of MT-2412 in Japanese Patients With Type 2 Diabetes (Add-on Study of Canagliflozin)
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 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 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.

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
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
138 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Canagliflozin + Teneligliptin
Arm Type
Experimental
Arm Description
Patients receive Canagliflozin for 24 weeks in combination with Teneligliptin.
Arm Title
Placebo + Teneligliptin
Arm Type
Placebo Comparator
Arm Description
Patients receive placebo for 24 weeks in combination with Teneligliptin.
Intervention Type
Drug
Intervention Name(s)
Teneligliptin
Other Intervention Name(s)
Tenelia, MP-513
Intervention Type
Drug
Intervention Name(s)
Canagliflozin
Other Intervention Name(s)
Canaglu, TA-7284
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary 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 24.
Time Frame
Baseline, 24 Weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in Fasting Plasma Glucose Level
Description
The change from baseline in fasting plasma glucose level collected at Week 24.
Time Frame
Baseline, 24 Weeks
Title
Percentage Change in Body Weight From Baseline
Description
The percentage change from baseline in body weight collected at Week 24.
Time Frame
Baseline, 24 Weeks
Title
Change From Baseline in the AUC(0-2h) for Postprandial Plasma Glucose (PPG)
Description
The change from Baseline in AUC(0-2h) for Postprandial Plasma Glucose collected at Week 24.
Time Frame
0, 0.5, 1 and 2 hour postprandial, at Baseline and 24 Weeks
Title
Change From Baseline in 2-hour Postprandial Plasma Glucose Level
Description
The change from baseline in 2-hour postprandial plasma glucose level collected at Week 24.
Time Frame
2 Hours Postprandial, at Baseline and 24 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
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
Kazuoki Kondo, MD
Organizational Affiliation
Mitsubishi Tanabe Pharma Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Reserch site
City
Kanto
Country
Japan
Facility Name
Reserch site
City
Kinki
Country
Japan
Facility Name
Reserch site
City
Tohoku
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
28177187
Citation
Kadowaki T, Inagaki N, Kondo K, Nishimura K, Kaneko G, Maruyama N, Nakanishi N, Iijima H, Watanabe Y, Gouda M. Efficacy and safety of canagliflozin as add-on therapy to teneligliptin in Japanese patients with type 2 diabetes mellitus: Results of a 24-week, randomized, double-blind, placebo-controlled trial. Diabetes Obes Metab. 2017 Jun;19(6):874-882. doi: 10.1111/dom.12898. Epub 2017 Mar 31.
Results Reference
result

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

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