Trial · Interventional

TerminatedPhase 4Results postedRegistry data

Evaluating the Use of Exenatide in People With Type 2 Diabetes and Diastolic Heart Failure

NCTNCT00799435Other id613Other id1K01HL092585Other id1K01HL092585-01Other idH-22906

Open at ClinicalTrials.govAsk about this trial

This trial was stopped early.

Reason given at the registry: Inability to recruit adequate Sample Size who met the entry criteria

Results were posted for this trial.

Overview

Status: Terminated
Phase: Phase 4
Enrollment: 2 participants (actual)
Sponsor: Baylor College of Medicine · Other
Design: Randomized · Open label (no masking)
Countries: 1 country
United States
Start: Jul 2009
Primary completion: Apr 2012
Completion: Apr 2012
First posted: 27 Nov 2008 (estimated)
Last update posted: 4 Sept 2020
Conditions: Diabetes Mellitus, Type 2 · Heart Failure, Diastolic

Timeline

1 trial · 1 stopped early · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20092010201120122013

Ph 4
Evaluating the Use of Exenatide in People With Type 2 Diabetes and Diastolic Heart Failure
NCT00799435
Jul 2009 to Apr 2012
Terminated
Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

People with type 2 diabetes experience heart failure more often than do people without diabetes. This may be due to increased stiffness in the heart as a result of diabetes. This study will examine whether exenatide, a medication used to treat diabetes, may have beneficial effects on the heart in people with type 2 diabetes and heart failure.

Interventions

ExenatideDrug

Arms2

No intervention
1
Participants will receive usual care for 12 weeks. The care will be dictated by the primary physician and/or diabetologist caring for the participant. Efforts will be made to ensure that all participants receive standard measures as indicated by guidelines, with a particular emphasis on blood pressure control and glucose control.
Experimental
2
Participants will receive exenatide for 12 weeks.

Primary outcomes1

Outcomes the sponsor listed as primary.

Change in Aortic Stiffness, as Measured by the Change in the Mean Aortic Pulse Wave Velocity
Time frame · Measured at Week 12

Secondary outcomes(1)

Changes in Left Ventricular Diastolic Stiffness, Serum Levels of Advanced Glycation End Products, Serum Biomarkers of Collagen Synthesis, and Serum Levels of Brain Natriuretic Peptide
Time frame · Measured at Week 12
Registry description
Given the cessation of trials, the biomarkers analyses and diastolic function measures were not performed.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Measured at Week 12

Change in Aortic Stiffness, as Measured by the Change in the Mean Aortic Pulse Wave Velocity

Group	Value (m/sec)	Spread
Usual Care	11.4	0
Exenatide	9.3	0

Secondary and other outcome results(1)

Secondary outcome· Measured at Week 12

Changes in Left Ventricular Diastolic Stiffness, Serum Levels of Advanced Glycation End Products, Serum Biomarkers of Collagen Synthesis, and Serum Levels of Brain Natriuretic Peptide

Group	Value
Usual Care	not posted
Exenatide	not posted

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Standard CareParticipants will receive usual care for 12 weeks. The care will be dictated by the primary physician and/or diabetologist caring for the participant. Efforts will be made to ensure that all participants receive standard measures as indicated by guidelines, with a particular emphasis on blood pressure control and glucose control.	–	0 / 1	0 / 1
ExenatideParticipants will receive exenatide for 12 weeks. Exenatide: 5 μg of exenatide subcutaneously twice a day for 4 weeks, followed by 10 μg of exenatide subcutaneously twice a day for an additional 8 weeks	–	0 / 1	0 / 1

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 30 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Stable New York Heart Association (NYHA) Class II-IV heart failure symptoms for at least 4 weeks before study entry * Diagnosis of diastolic heart failure with a normal ejection fraction * Admitted to the hospital with a diagnosis of heart failure in the 12 months before study entry * Type 2 diabetes Exclusion Criteria: * Unstable angina, heart attack, coronary artery bypass surgery, or angioplasty in the 3 months before study entry * Angina with exertion * Technically inadequate echocardiogram * Atrial fibrillation or atrial flutter * Severe valvular heart disease * Significant kidney insufficiency (serum creatinine greater than 2.0 mg/dL or require hemodialysis) * Conditions that may be associated with changes in markers of fibrosis or collagen turnover (e.g., ongoing or active rheumatological disease, requiring significant anti-inflammatory agents, immunosuppression, pulmonary fibrosis, active cancer) * Significant history of active substance abuse * Type 1 diabetes * Type 2 diabetes requiring chronic insulin use before study entry * Active thiazolidinedione (TZD) use, because TZDs have been shown to worsen volume retention and may exacerbate signs and/or symptoms of heart failure * Pregnant or breastfeeding * Hypertrophic cardiomyopathy

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