NCT00799435

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for phase_4 diabetes-mellitus-type-2

Timeline
Completed

Started Jul 2009

Longer than P75 for phase_4 diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

November 26, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 27, 2008

Completed
7 months until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
5.5 years until next milestone

Results Posted

Study results publicly available

September 21, 2017

Completed
Last Updated

September 4, 2020

Status Verified

September 1, 2020

Enrollment Period

2.8 years

First QC Date

November 26, 2008

Results QC Date

August 25, 2017

Last Update Submit

September 2, 2020

Conditions

Diabetes Mellitus, Type 2Heart Failure, Diastolic

Keywords

DiabetesDiastolic Heart FailureAortic StiffnessExenatide

Outcome Measures

Primary Outcomes (1)

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

    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

    Measured at Week 12

Study Arms (2)

1

NO INTERVENTION

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.

2

EXPERIMENTAL

Participants will receive exenatide for 12 weeks.

Drug: Exenatide

Interventions

ExenatideDRUG

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

Also known as: Byetta
2

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Heart Failure, DiastolicDiabetes Mellitus

Interventions

Exenatide

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHeart FailureHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PeptidesAmino Acids, Peptides, and ProteinsVenomsComplex MixturesToxins, BiologicalBiological Factors

Limitations and Caveats

The study was stopped due to difficulties enrolling and fulfilling entry criteria

Results Point of Contact

Title
David Aguilar, MD
Organization
Baylor
daguilar@bcm.edu
713-798-0280

Study Officials

  • David Aguilar, MD

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 26, 2008

First Posted

November 27, 2008

Study Start

July 1, 2009

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

September 4, 2020

Results First Posted

September 21, 2017

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)