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Efficacy and Mechanism of Exenatide on Improving Heart Function in Type 2 Diabetes With Heart Failure Patients

Primary Purpose

Type 2 Diabetes Mellitus, Heart Failure

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Exenatide
Sponsored by
Chinese Academy of Medical Sciences, Fuwai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Diagnosed Type 2 diabetes mellitus
  2. HbA1c 7%-10% and Fasting plasma glucose(FBG) <10mmol/L
  3. Age 18-65 years
  4. NT-proBNP level≥ 450 pg/ml
  5. Left ventricular ejection fraction (LVEF)<40%

Exclusion Criteria:

  1. Uncorrected primary vascular disease
  2. congenital heart disease
  3. Left ventricular outflow obstruction
  4. Myocarditis
  5. Aneurysm
  6. uncontrolled severe arrhythmia
  7. cardiogenic shock
  8. unstable angina, or acute myocardial infarction
  9. Severe primary hepatic, renal, or hematologic disease
  10. Cr>194.5 mmol/l or K+>5.5 mmol/l
  11. Systolic blood pressure (SBP) ≥180mm Hg or diastolic blood pressure (DBP) ≥110mm Hg
  12. Alanine aminotransferase (ALT) >3 times the upper normal limit
  13. Patients were likely to undergo coronary artery bypass graft surgery during the following 4 weeks
  14. Patients had undergone or were likely to undergo cardiac resynchronization therapy
  15. Pregnant or lactating known
  16. Suspected to be allergic to the study drugs
  17. Use dipeptidyl peptidase-4 (DPP-4) or glucagon-like peptide-1 (GLP-1) drug in 3 months
  18. Hyperthyroidism and Hypothyroidism
  19. Tumor
  20. Received another investigational drug within 30 days prior to randomization
  21. Severe mental health condition or other uncontrolled systemic disease.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Exenatide

    control group

    Arm Description

    exenatide group receive exenatide (5μg, subcutaneous injection, Bid）

    control group do not receive exenatide

    Outcomes

    Primary Outcome Measures

    The change in plasma NT-proBNP level after using exenatide for 4 weeks

    Secondary Outcome Measures

    Full Information

    First Posted
    January 13, 2015
    Last Updated
    January 26, 2015
    Sponsor
    Chinese Academy of Medical Sciences, Fuwai Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02344641
    Brief Title
    Efficacy and Mechanism of Exenatide on Improving Heart Function in Type 2 Diabetes With Heart Failure Patients
    Official Title
    Efficacy and Mechanism of Exenatide on Improving Heart Function in Type 2 Diabetes With Heart Failure Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2015 (undefined)
    Primary Completion Date
    December 2016 (Anticipated)
    Study Completion Date
    December 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Chinese Academy of Medical Sciences, Fuwai Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The study evaluates the efficacy of heart function improvements in type 2 diabetes and heart failure patients with exenatide, and also investigates the mechanisms of exenatide improving heart function.
    Detailed Description
    The study enrolls 234 patients with type 2 diabetes and heart failure. The patients have an New York Heart Association (NYHA) functional class of II to IV, are randomly assigned to 2 groups. One group use exenatide , the other group is control group and each group has 117 patients. At the baseline, the 3rd day, the 28th day patients are required to complete the heart failure examination: plasma N-terminal pro-B-type natriuretic peptide(NT-proBNP), 6-min walking distance, echocardiographic measures, patient quality of life(MLHFQ). At the end of 4-week follow-up, we evaluate the efficacy of heart function improvements after treatment with exenatide and also investigate the mechanisms of exenatide improving heart function .

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Type 2 Diabetes Mellitus, Heart Failure

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    234 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Exenatide
    Arm Type
    Experimental
    Arm Description
    exenatide group receive exenatide (5μg, subcutaneous injection, Bid）
    Arm Title
    control group
    Arm Type
    No Intervention
    Arm Description
    control group do not receive exenatide
    Intervention Type
    Drug
    Intervention Name(s)
    Exenatide
    Primary Outcome Measure Information:
    Title
    The change in plasma NT-proBNP level after using exenatide for 4 weeks
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosed Type 2 diabetes mellitus HbA1c 7%-10% and Fasting plasma glucose(FBG) <10mmol/L Age 18-65 years NT-proBNP level≥ 450 pg/ml Left ventricular ejection fraction (LVEF)<40% Exclusion Criteria: Uncorrected primary vascular disease congenital heart disease Left ventricular outflow obstruction Myocarditis Aneurysm uncontrolled severe arrhythmia cardiogenic shock unstable angina, or acute myocardial infarction Severe primary hepatic, renal, or hematologic disease Cr>194.5 mmol/l or K+>5.5 mmol/l Systolic blood pressure (SBP) ≥180mm Hg or diastolic blood pressure (DBP) ≥110mm Hg Alanine aminotransferase (ALT) >3 times the upper normal limit Patients were likely to undergo coronary artery bypass graft surgery during the following 4 weeks Patients had undergone or were likely to undergo cardiac resynchronization therapy Pregnant or lactating known Suspected to be allergic to the study drugs Use dipeptidyl peptidase-4 (DPP-4) or glucagon-like peptide-1 (GLP-1) drug in 3 months Hyperthyroidism and Hypothyroidism Tumor Received another investigational drug within 30 days prior to randomization Severe mental health condition or other uncontrolled systemic disease.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    XinXing Feng, MD
    Phone
    :86-10-88396587
    Email
    xinxing_feng@hotmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    YanYan Chen, MD
    Organizational Affiliation
    Fuwai Hospital, National Center for Cardiovascular Disease
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Efficacy and Mechanism of Exenatide on Improving Heart Function in Type 2 Diabetes With Heart Failure Patients

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