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

Chinese Academy of Medical Sciences, Fuwai Hospital

Status: Unknown

Conditions: Type 2 Diabetes Mellitus; Heart Failure

Treatments: Drug: Exenatide

Study type: Interventional

Funder types: Other

Identifiers

NCT02344641

ISSEXEN0054

Details and patient eligibility

About

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.

Full 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 .

Enrollment: 234 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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234 participants in 2 patient groups

Exenatide

Experimental group

Description:

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

Treatment:

Drug: Exenatide

control group

No Intervention group

Description:

control group do not receive exenatide