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

Sponsor
Mitsubishi Tanabe Pharma Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT02354222
Collaborator
(none)
154
Enrollment
3
Locations
2
Arms
13
Duration (Months)
51.3
Patients Per Site
3.9
Patients Per Site Per Month

Study Details

Study Description

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
Phase 3

Study Design

Study Type:
Interventional
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 :
Jan 1, 2015
Actual Primary Completion Date :
Feb 1, 2016
Actual Study Completion Date :
Feb 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Teneligliptin + Canagliflozin

Patients receive Teneligliptin for 24 weeks in combination with Canagliflozin.

Drug: Canagliflozin
Other Names:
  • Canaglu, TA-7284

    • Drug: Teneligliptin
    Other Names:
  • Tenelia, MP-513

    		•
    Placebo Comparator: Placebo + Canagliflozin

    Patients receive placebo for 24 weeks in combination with Canagliflozin.

    Drug: Canagliflozin
    Other Names:
  • Canaglu, TA-7284

    • Drug: Placebo

    Outcome Measures

    Primary Outcome Measures

    1. Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c) [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 [Baseline, 24 Weeks]

      The change from baseline in fasting plasma glucose level collected at Week 24.

    2. Percentage Change in Body Weight From Baseline [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) [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 [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

    Criteria

    Ages Eligible for Study:
    20 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Reserch site Kanto Japan
    2 Reserch site Kinki Japan
    3 Reserch site Tohoku Japan

    Sponsors and Collaborators

    • Mitsubishi Tanabe Pharma Corporation

    Investigators

    • Study Director: Takashi Kadowaki, M.D., Tokyo University
    • Study Director: Kazuoki Kondo, M.D., Mitsubishi Tanabe Pharma Corporation

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mitsubishi Tanabe Pharma Corporation
    ClinicalTrials.gov Identifier:
    NCT02354222
    Other Study ID Numbers:
    • MT-2412-J02
    First Posted:
    Feb 3, 2015
    Last Update Posted:
    Nov 1, 2018
    Last Verified:
    Oct 1, 2018
    Keywords provided by Mitsubishi Tanabe Pharma Corporation
    MT-2412
    MP-513
    TA-7284
    Teneligliptin
    Canagliflozin
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 2
    Canagliflozin

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Teneligliptin+Canagliflozin Placebo+Canagliflozin
    Arm/Group Description Teneligliptin for 24 weeks in combination with Canagliflozin Placebo for 24 weeks in combination with Canagliflozin
    Period Title: Overall Study
    STARTED 77 77
    COMPLETED 73 66
    NOT COMPLETED 4 11

    Baseline Characteristics

    Arm/Group Title Teneligliptin+Canagliflozin Placebo+Canagliflozin Total
    Arm/Group Description Teneligliptin for 24 weeks in combination with Canagliflozin Placebo for 24 weeks in combination with Canagliflozin Total of all reporting groups
    Overall Participants 77 77 154
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    66
    85.7%
    61
    79.2%
    127
    82.5%
    >=65 years
    11
    14.3%
    16
    20.8%
    27
    17.5%
    Sex: Female, Male (Count of Participants)
    Female
    13
    16.9%
    19
    24.7%
    32
    20.8%
    Male
    64
    83.1%
    58
    75.3%
    122
    79.2%

    Outcome Measures

    1. Primary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    Full analysis set, last observation carried forward
    Arm/Group Title Teneligliptin+Canagliflozin Placebo+Canagliflozin
    Arm/Group Description Teneligliptin for 24 weeks in combination with Canagliflozin Placebo for 24 weeks in combination with Canagliflozin
    Measure Participants 77 77
    Least Squares Mean (Standard Error) [percentage of HbA1c]
    -0.94
    (0.08)
    0.00
    (0.08)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Teneligliptin+Canagliflozin, Placebo+Canagliflozin
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -0.94
    Confidence Interval (2-Sided) 95%
    -1.16 to -0.72
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.11
    Estimation Comments
    2. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    Full analysis set, last observation carried forward. Outcome measure for one patient was not assessed at a certain timepoint due to dropout.
    Arm/Group Title Teneligliptin+Canagliflozin Placebo+Canagliflozin
    Arm/Group Description Teneligliptin for 24 weeks in combination with Canagliflozin Placebo for 24 weeks in combination with Canagliflozin
    Measure Participants 77 76
    Least Squares Mean (Standard Error) [mg/dL]
    -5.6
    (2.7)
    10.0
    (2.8)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Teneligliptin+Canagliflozin, Placebo+Canagliflozin
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -15.6
    Confidence Interval (2-Sided) 95%
    -23.3 to -7.9
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 3.9
    Estimation Comments
    3. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    Full analysis set, last observation carried forward. Outcome measure for one patient was not assessed at a certain timepoint due to dropout.
    Arm/Group Title Teneligliptin+Canagliflozin Placebo+Canagliflozin
    Arm/Group Description Teneligliptin for 24 weeks in combination with Canagliflozin Placebo for 24 weeks in combination with Canagliflozin
    Measure Participants 77 76
    Least Squares Mean (Standard Error) [percent change]
    0.09
    (0.29)
    -1.34
    (0.29)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Teneligliptin+Canagliflozin, Placebo+Canagliflozin
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value 1.43
    Confidence Interval (2-Sided) 95%
    0.63 to 2.23
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.41
    Estimation Comments
    4. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    Full analysis set. Outcome measure for one patient was not assessed at a certain timepoint due to dropout.
    Arm/Group Title Teneligliptin+Canagliflozin Placebo+Canagliflozin
    Arm/Group Description Teneligliptin for 24 weeks in combination with Canagliflozin Placebo for 24 weeks in combination with Canagliflozin
    Measure Participants 73 65
    Least Squares Mean (Standard Error) [hour*mg/dL]
    -50.2
    (6.3)
    5.7
    (6.7)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Teneligliptin+Canagliflozin, Placebo+Canagliflozin
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -55.9
    Confidence Interval (2-Sided) 95%
    -74.1 to -37.6
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 9.2
    Estimation Comments
    5. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    Full analysis set. Outcome measure for one patient was not assessed at a certain timepoint due to dropout.
    Arm/Group Title Teneligliptin+Canagliflozin Placebo+Canagliflozin
    Arm/Group Description Teneligliptin for 24 weeks in combination with Canagliflozin Placebo for 24 weeks in combination with Canagliflozin
    Measure Participants 73 65
    Least Squares Mean (Standard Error) [mg/dL]
    -35.3
    (4.3)
    2.3
    (4.5)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Teneligliptin+Canagliflozin, Placebo+Canagliflozin
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Least Squares Mean Difference
    Estimated Value -37.6
    Confidence Interval (2-Sided) 95%
    -49.9 to -25.2
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.2
    Estimation Comments

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Teneligliptin+Canagliflozin Placebo+Canagliflozin
    Arm/Group Description Teneligliptin for 24 weeks in combination with Canagliflozin Placebo for 24 weeks in combination with Canagliflozin
    All Cause Mortality
    Teneligliptin+Canagliflozin Placebo+Canagliflozin
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Teneligliptin+Canagliflozin Placebo+Canagliflozin
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/77 (1.3%) 2/77 (2.6%)
    Gastrointestinal disorders
    Large intestine polyp 1/77 (1.3%) 0/77 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Colon cancer 0/77 (0%) 1/77 (1.3%)
    Pancreatic carcinoma 0/77 (0%) 1/77 (1.3%)
    Other (Not Including Serious) Adverse Events
    Teneligliptin+Canagliflozin Placebo+Canagliflozin
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 15/77 (19.5%) 8/77 (10.4%)
    Infections and infestations
    Nasopharyngitis 12/77 (15.6%) 8/77 (10.4%)
    Upper respiratory tract infection 4/77 (5.2%) 0/77 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    Results Point of Contact

    Name/Title Clinical Trials, Information Desk
    Organization Mitsubishi Tanabe Pharma Corporation
    Phone
    Email cti-inq-ml@ml.mt-pharma.co.jp
    Responsible Party:
    Mitsubishi Tanabe Pharma Corporation
    ClinicalTrials.gov Identifier:
    NCT02354222
    Other Study ID Numbers:
    • MT-2412-J02
    First Posted:
    Feb 3, 2015
    Last Update Posted:
    Nov 1, 2018
    Last Verified:
    Oct 1, 2018