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
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus
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.
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
NCT ID
NCT02344641
First Posted
January 13, 2015
Last Updated
January 26, 2015
Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
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
Learn more about this trial
Efficacy and Mechanism of Exenatide on Improving Heart Function in Type 2 Diabetes With Heart Failure Patients
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