NCT02344641

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
234

participants targeted

Target at P75+ for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Jan 2015

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 26, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 27, 2015

Status Verified

January 1, 2015

Enrollment Period

1.9 years

First QC Date

January 13, 2015

Last Update Submit

January 26, 2015

Conditions

Type 2 Diabetes MellitusHeart Failure

Outcome Measures

Primary Outcomes (1)

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

    4 weeks

Study Arms (2)

Exenatide

EXPERIMENTAL

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

Drug: Exenatide

control group

NO INTERVENTION

control group do not receive exenatide

Interventions

ExenatideDRUG
Exenatide

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%

You may not qualify if:

  • 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
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Heart Failure

Interventions

Exenatide

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PeptidesAmino Acids, Peptides, and ProteinsVenomsComplex MixturesToxins, BiologicalBiological Factors

Study Officials

  • YanYan Chen, MD

    Fuwai Hospital, National Center for Cardiovascular Disease

    PRINCIPAL INVESTIGATOR

Central Study Contacts

XinXing Feng, MD

CONTACT

:86-10-88396587xinxing_feng@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director，endocrinology and cardiology centre

Study Record Dates

First Submitted

January 13, 2015

First Posted

January 26, 2015

Study Start

January 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

January 27, 2015

Record last verified: 2015-01