Type 2 Diabetes MellitusNCT02344641
Efficacy and Mechanism of Exenatide on Improving Heart Function in Type 2 Diabetes With Heart Failure Patients
A study testing Exenatide in people with Type 2 Diabetes Mellitus and Heart Failure, run by Chinese Academy of Medical Sciences, Fuwai Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Heart Failure
- What is being tested?
- Exenatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- Uncorrected primary vascular disease
- congenital heart disease
- Left ventricular outflow obstruction
- Myocarditis
- Aneurysm
- uncontrolled severe arrhythmia
Show all 21Show fewer
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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 .
- Conditions
- Type 2 Diabetes Mellitus, Heart Failure
- Being tested
- Exenatide
- Medical subject headings
- Diabetes Mellitus, Type 2, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExenatideDrug
| Study group | Role | What they receive |
|---|---|---|
| Exenatide | Experimental | exenatide group receive exenatide (5μg, subcutaneous injection, Bid） Receives: Drug: Exenatide |
| control group | No intervention | control group do not receive exenatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in plasma NT-proBNP level after using exenatide for 4 weeks
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Chinese Academy of Medical Sciences, Fuwai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 234 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YanYan Chen, Chinese Academy of Medical Sciences, Fuwai Hospital
- Investigators
- YanYan Chen, MD, Principal investigator, Fuwai Hospital, National Center for Cardiovascular Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02344641
- Sponsor's protocol ID
- ISSEXEN0054
- Status last verified
- Jan 2015
- First submitted
- 13 Jan 2015
- Last updated
- 27 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Mechanism of Exenatide on Improving Heart Function in Type 2 Diabetes With Heart Failure Patients
- ClinicalTrials.gov ID
- NCT02344641
- Acronym / sponsor ID
- ISSEXEN0054
- Conditions
- Type 2 Diabetes Mellitus, Heart Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 234 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 26 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exenatide | Experimental | Drug: Exenatideexenatide group receive exenatide (5μg, subcutaneous injection, Bid） |
| control group | No intervention | –control group do not receive exenatide |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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%
Key exclusion criteria (21 listed)
- Uncorrected primary vascular disease
- congenital heart disease
- Left ventricular outflow obstruction
- Myocarditis
- Aneurysm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exenatide | Drug | Exenatide |
Primary outcome
The change in plasma NT-proBNP level after using exenatide for 4 weeks
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
YanYan Chen, MD principal investigator
Fuwai Hospital, National Center for Cardiovascular Disease
Questions about this trial
What is this clinical trial studying?
A study testing Exenatide in people with Type 2 Diabetes Mellitus and Heart Failure, run by Chinese Academy of Medical Sciences, Fuwai Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact XinXing Feng, MD (:86-10-88396587, xinxing_feng@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in plasma NT-proBNP level after using exenatide for 4 weeks (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2015.