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GLP-1 Receptor Agonist

Bydureon for Type 2 Diabetes

Phase 4
Waitlist Available
Led By Peter D Reaven, MD
Research Sponsored by Phoenix VA Health Care System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights

Study 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.

Eligible Conditions
  • Type 2 Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in carotid plaque volume
Secondary outcome measures
Change in carotid plaque composition
Change in reactive hyperemic index

Side effects data

From 2015 Phase 4 trial • 239 Patients • NCT02288273
10%
Injection site nodule
7%
Urinary tract infection
7%
Nausea
5%
Diarrhea
5%
Hematuria
5%
Musculoskeletal pain
5%
Injection site induration
5%
Proteinuria
3%
Lipase increased
3%
Glycosuria
3%
Vomiting
3%
Amylase increased
3%
Upper respiratory tract infection
3%
Anemia
3%
Gastroenteritis
2%
Nephrolithiasis
2%
Acute Pancreatitis
2%
Bronchitis
2%
Chest Pain
2%
Non-Cardiac Chest Pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo + Met
EQW + Met

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: BydureonExperimental Treatment1 Intervention
injectable medication Bydureon
Group II: PlaceboPlacebo Group1 Intervention
a similar looking injectable
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Exenatide
FDA approved

Find a Location

Who is running the clinical trial?

Phoenix VA Health Care SystemLead Sponsor
12 Previous Clinical Trials
1,327 Total Patients Enrolled
Peter D Reaven, MDPrincipal InvestigatorCarl T. Hayden Medical Research Foundation
5 Previous Clinical Trials
1,521 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Effect of Bydureon on Carotid Atherosclerosis Progression in Type 2 Diabetes Mellitus
Peter Reaven 2014. "Effect of Bydureon on Carotid Atherosclerosis Progression in Type 2 Diabetes Mellitus". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02162550.
All > Atherosclerosis > Bydureon
~14 spots leftby Apr 2025
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