Trial · Interventional

Status unknownPhase 4Registry data

Effect of Bydureon on Carotid Atherosclerosis Progression in Type 2 Diabetes Mellitus

NCTNCT02162550Other id1026

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Status unknown
Phase: Phase 4
Enrollment: 148 participants (estimated)
Sponsor: Phoenix VA Health Care System · Fed
Design: Randomized · Quadruple masking
Countries: 1 country
United States
Start: Jun 2014
Primary completion: Apr 2019 (estimated)
Completion: Sept 2019 (estimated)
First posted: 12 Jun 2014 (estimated)
Last update posted: 14 Jun 2018
Conditions: Type 2 Diabetes

Timeline

1 trial

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

2014201520162017201820192020

Ph 4
Effect of Bydureon on Carotid Atherosclerosis Progression in Type 2 Diabetes Mellitus
NCT02162550
Jun 2014 to est. Sept 2019

Registry summary

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

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.

Interventions

BydureonDrug
placeboDrug

Arms2

Experimental
Bydureon
injectable medication Bydureon
Placebo comparator
Placebo
a similar looking injectable

Primary outcomes1

Outcomes the sponsor listed as primary.

Change in carotid plaque volume
Time frame · 18 months
Registry description
To determine the difference in change in carotid plaque volume, using 3 tesla (3T) MRI, between T2DM patients treated with Bydureon or placebo.

Secondary outcomes(2)

Change in reactive hyperemic index
Time frame · 18 months
Registry description
To determine the effects of long-term Bydureon therapy on vascular function as measured by the difference in fasting and post prandial reactive hyperemic index using peripheral artery tonometry.
Change in carotid plaque composition
Time frame · 18 months
Registry description
To determine the difference in change in carotid plaque composition, using 3 tesla (3T) MRI, between T2DM patients treated with Bydureon or placebo.

Posted results

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

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

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

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2021

13 results

The Effect of Exenatide Once Weekly on Carotid Atherosclerosis in Individuals With Type 2 Diabetes: An 18-Month Randomized Placebo-Controlled Study.

Koska et al. 2021Diabetes carecited by 27

PMID 33495294PMC8247511DOI 10.2337/dc20-2014PUB-33495294

Rights unknown13 results

Source link See results (13)

Eligibility

Who could join, as posted.

Sex: All
Age: from 21 Years up to 75 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * 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 Exclusion Criteria: * 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

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