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

Sponsor
Mitsubishi Tanabe Pharma Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT02354235
Collaborator
(none)
138
Enrollment
3
Locations
2
Arms
12
Duration (Months)
46
Patients Per Site
3.8
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 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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
138 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 Canagliflozin in Patients With Inadequate Glycemic Control on Teneligliptin)
Study Start Date :
Jan 1, 2015
Actual Primary Completion Date :
Jan 1, 2016
Actual Study Completion Date :
Jan 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Canagliflozin + Teneligliptin

Patients receive Canagliflozin for 24 weeks in combination with Teneligliptin.

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

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

    		•
    Placebo Comparator: Placebo + Teneligliptin

    Patients receive placebo for 24 weeks in combination with Teneligliptin.

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

    • 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, MD, Tokyo University
    • Study Director: Kazuoki Kondo, MD, Mitsubishi Tanabe Pharma Corporation

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mitsubishi Tanabe Pharma Corporation
    ClinicalTrials.gov Identifier:
    NCT02354235
    Other Study ID Numbers:
    • MT-2412-J03
    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 Canagliflozin+Teneligliptin Placebo+Teneligliptin
    Arm/Group Description Canagliflozin for 24 weeks in combination with Teneligliptin Placebo for 24 weeks in combination with Teneligliptin
    Period Title: Overall Study
    STARTED 70 68
    COMPLETED 67 61
    NOT COMPLETED 3 7

    Baseline Characteristics

    Arm/Group Title Canagliflozin+Teneligliptin Placebo+Teneligliptin Total
    Arm/Group Description Canagliflozin for 24 weeks in combination with Teneligliptin Placebo for 24 weeks in combination with Teneligliptin Total of all reporting groups
    Overall Participants 70 68 138
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    48
    68.6%
    52
    76.5%
    100
    72.5%
    >=65 years
    22
    31.4%
    16
    23.5%
    38
    27.5%
    Sex: Female, Male (Count of Participants)
    Female
    16
    22.9%
    15
    22.1%
    31
    22.5%
    Male
    54
    77.1%
    53
    77.9%
    107
    77.5%

    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 Canagliflozin+Teneligliptin Placebo+Teneligliptin
    Arm/Group Description Canagliflozin for 24 weeks in combination with Teneligliptin Placebo for 24 weeks in combination with Teneligliptin
    Measure Participants 70 68
    Least Squares Mean (Standard Error) [percentage of HbA1c]
    -0.97
    (0.10)
    -0.10
    (0.10)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Canagliflozin+Teneligliptin, Placebo+Teneligliptin
    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 -0.88
    Confidence Interval (2-Sided) 95%
    -1.15 to -0.60
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.14
    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 of each group was not assessed at a certain timepoint due to dropout.
    Arm/Group Title Canagliflozin+Teneligliptin Placebo+Teneligliptin
    Arm/Group Description Canagliflozin for 24 weeks in combination with Teneligliptin Placebo for 24 weeks in combination with Teneligliptin
    Measure Participants 69 67
    Least Squares Mean (Standard Error) [mg/dL]
    -34.9
    (3.4)
    3.9
    (3.5)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Canagliflozin+Teneligliptin, Placebo+Teneligliptin
    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 -38.8
    Confidence Interval (2-Sided) 95%
    -48.5 to -29.2
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.9
    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 of each group was not assessed at a certain timepoint due to dropout.
    Arm/Group Title Canagliflozin+Teneligliptin Placebo+Teneligliptin
    Arm/Group Description Canagliflozin for 24 weeks in combination with Teneligliptin Placebo for 24 weeks in combination with Teneligliptin
    Measure Participants 69 67
    Least Squares Mean (Standard Error) [percent change]
    -3.32
    (0.31)
    -0.99
    (0.31)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Canagliflozin+Teneligliptin, Placebo+Teneligliptin
    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 -2.33
    Confidence Interval (2-Sided) 95%
    -3.20 to -1.45
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.44
    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
    Arm/Group Title Canagliflozin+Teneligliptin Placebo+Teneligliptin
    Arm/Group Description Canagliflozin for 24 weeks in combination with Teneligliptin Placebo for 24 weeks in combination with Teneligliptin
    Measure Participants 67 61
    Least Squares Mean (Standard Error) [hour*mg/dL]
    -105.9
    (7.6)
    -5.6
    (8.0)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Canagliflozin+Teneligliptin, Placebo+Teneligliptin
    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 -100.3
    Confidence Interval (2-Sided) 95%
    -122.2 to -78.4
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 11.1
    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
    Arm/Group Title Canagliflozin+Teneligliptin Placebo+Teneligliptin
    Arm/Group Description Canagliflozin for 24 weeks in combination with Teneligliptin Placebo for 24 weeks in combination with Teneligliptin
    Measure Participants 67 61
    Least Squares Mean (Standard Error) [mg/dL]
    -60.1
    (4.9)
    -9.2
    (5.1)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Canagliflozin+Teneligliptin, Placebo+Teneligliptin
    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 -50.9
    Confidence Interval (2-Sided) 95%
    -64.9 to -36.9
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.1
    Estimation Comments

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Canagliflozin+Teneligliptin Placebo+Teneligliptin
    Arm/Group Description Canagliflozin for 24 weeks in combination with Teneligliptin Placebo for 24 weeks in combination with Teneligliptin
    All Cause Mortality
    Canagliflozin+Teneligliptin Placebo+Teneligliptin
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Canagliflozin+Teneligliptin Placebo+Teneligliptin
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/70 (1.4%) 2/68 (2.9%)
    Musculoskeletal and connective tissue disorders
    Chondrocalcinosis pyrophosphate 0/70 (0%) 1/68 (1.5%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Gastric cancer 1/70 (1.4%) 0/68 (0%)
    Nervous system disorders
    Cerebral infarction 0/70 (0%) 1/68 (1.5%)
    Other (Not Including Serious) Adverse Events
    Canagliflozin+Teneligliptin Placebo+Teneligliptin
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 13/70 (18.6%) 11/68 (16.2%)
    Infections and infestations
    Nasopharyngitis 13/70 (18.6%) 11/68 (16.2%)

    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:
    NCT02354235
    Other Study ID Numbers:
    • MT-2412-J03
    First Posted:
    Feb 3, 2015
    Last Update Posted:
    Nov 1, 2018
    Last Verified:
    Oct 1, 2018