NCT02162550

Brief Summary

Investigators will be determining whether a once weekly injectable medication Bydureon versus placebo is able to reduce the development of atherosclerosis. Investigators are testing the overall hypothesis that 18 months of Bydureon treatment will improve cardiovascular risk factors, endothelial function and retard carotid atherosclerosis plaque progression in type 2 diabetes mellitus (T2DM). Investigators anticipate these studies will provide novel information about the temporal relationship between Bydureon induced changes in risk factors, endothelial function and atherosclerosis progression.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
148

participants targeted

Target at P50-P75 for phase_4 type-2-diabetes

Timeline
Completed

Started Jun 2014

Longer than P75 for phase_4 type-2-diabetes

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

May 27, 2014

Completed
5 days until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 12, 2014

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

June 14, 2018

Status Verified

June 1, 2018

Enrollment Period

4.8 years

First QC Date

May 27, 2014

Last Update Submit

June 12, 2018

Conditions

Type 2 Diabetes

Keywords

Type 2 DiabetesCardiovascular DiseaseHyperglycemiaCarotid PlaqueEndothelial functionIncretinsAtherosclerosis

Outcome Measures

Primary Outcomes (1)

  • Change in carotid plaque volume

    To determine the difference in change in carotid plaque volume, using 3 tesla (3T) MRI, between T2DM patients treated with Bydureon or placebo.

    18 months

Secondary Outcomes (2)

  • Change in reactive hyperemic index

    18 months

  • Change in carotid plaque composition

    18 months

Study Arms (2)

Bydureon

EXPERIMENTAL

injectable medication Bydureon

Drug: Bydureon

Placebo

PLACEBO COMPARATOR

a similar looking injectable

Drug: placebo

Interventions

BydureonDRUG

once weekly injection

Also known as: long-acting exenatide
Bydureon
placeboDRUG

once weekly injection

Also known as: inactive agent
Placebo

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • males and females of any race and ethnicity with T2DM, HbA1c of ≥6.5% and ≤10.0% on diet only
  • take stable doses of oral antihyperglycemic agents with or without long-acting insulin
  • must have a regular primary care provider (PCP) that is amenable to patient study participation and will facilitate (blinded to the treatment) the research team's study protocol efforts

You may not qualify if:

  • type 1 diabetes mellitus (T1DM)
  • current or recent glucagon-like peptide 1 receptor (GLP-1R) agonist use
  • contraindications to MRI (e.g., claustrophobia, ferromagnetic materials, body habitus inappropriate for MRI exam)
  • screening carotid ultrasound plaque thickness of \<0.75 mm, prior or anticipated carotid stenting or endarterectomy
  • recent CVD (past 6 months) or other major illness or conditions affecting risk (e.g., pancreatitis, severe renal disease) or personal or family history of medullary thyroid carcinoma
  • patients with Multiple Endocrine Neoplasia syndrome type 2
  • serious hypersensitivity to exenatide or any product components
  • severe gastrointestinal disease, or pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Phoenix VA Health Care System

Phoenix, Arizona, 85012, United States

Location

Related Publications (1)

  • Koska J, Migrino RQ, Chan KC, Cooper-Cox K, Reaven PD. The Effect of Exenatide Once Weekly on Carotid Atherosclerosis in Individuals With Type 2 Diabetes: An 18-Month Randomized Placebo-Controlled Study. Diabetes Care. 2021 Jun;44(6):1385-1392. doi: 10.2337/dc20-2014. Epub 2021 Jan 25.

    PMID: 33495294DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Cardiovascular DiseasesHyperglycemiaAtherosclerosis

Interventions

Exenatide

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

PeptidesAmino Acids, Peptides, and ProteinsVenomsComplex MixturesToxins, BiologicalBiological Factors

Study Officials

  • Peter D Reaven, MD

    Carl T. Hayden Medical Research Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Diabetes Program

Study Record Dates

First Submitted

May 27, 2014

First Posted

June 12, 2014

Study Start

June 1, 2014

Primary Completion

April 1, 2019

Study Completion

September 1, 2019

Last Updated

June 14, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Subject to VA regulation.

Locations

US(1)