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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02354222
Recruitment Status : Completed
First Posted : February 3, 2015
Results First Posted : August 16, 2018
Last Update Posted : November 1, 2018
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Canagliflozin Drug: Teneligliptin Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Confirmatory Study of MT-2412 in Japanese Patients With Type 2 Diabetes (Add-on Study of Teneligliptin in Patients With Inadequate Glycemic Control on Canagliflozin)
Study Start Date : January 2015
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Teneligliptin + Canagliflozin
Patients receive Teneligliptin for 24 weeks in combination with Canagliflozin.
 Drug: Canagliflozin
Other Name: Canaglu, TA-7284

Drug: Teneligliptin
Other Name: Tenelia, MP-513
Placebo Comparator: Placebo + Canagliflozin
Patients receive placebo for 24 weeks in combination with Canagliflozin.
 Drug: Canagliflozin
Other Name: Canaglu, TA-7284

Drug: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Percentage Change in Body Weight From Baseline [ Time Frame: Baseline, 24 Weeks ]
    The percentage change from baseline in body weight collected at Week 24.

  3. 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.

  4. 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.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02354222


Locations
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Japan
Reserch site
Kanto, Japan
Reserch site
Kinki, Japan
Reserch site
Tohoku, Japan
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
Investigators
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Study Director: Takashi Kadowaki, M.D. Tokyo University
Study Director: Kazuoki Kondo, M.D. Mitsubishi Tanabe Pharma Corporation
More Information
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Publications of Results:

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Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT02354222    
Other Study ID Numbers: MT-2412-J02
First Posted: February 3, 2015    Key Record Dates
Results First Posted: August 16, 2018
Last Update Posted: November 1, 2018
Last Verified: October 2018
Keywords provided by Mitsubishi Tanabe Pharma Corporation:
MT-2412
MP-513
TA-7284
Teneligliptin
Canagliflozin
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Canagliflozin
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs