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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02344641
Other study ID # ISSEXEN0054
Secondary ID
Status Not yet recruiting
Phase N/A
First received January 13, 2015
Last updated January 26, 2015
Start date January 2015
Est. completion date December 2016

Study information

Verified date January 2015
Source Chinese Academy of Medical Sciences, Fuwai Hospital
Contact XinXing Feng, MD
Phone :86-10-88396587
Email xinxing_feng@hotmail.com
Is FDA regulated No
Health authority China: Ministry of Health
Study type Interventional

Clinical Trial 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.


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 .


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 234
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
Exenatide


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary The change in plasma NT-proBNP level after using exenatide for 4 weeks 4 weeks No
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