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GLP-1 Receptor Agonist
Effect of Bydureon on Carotid Atherosclerosis Progression in Type 2 Diabetes Mellitus
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
All Individual Drugs Already Approved
Drug Has Already Been Approved
Pivotal Trial
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in carotid plaque volume
Secondary study objectives
Change in carotid plaque composition
Change in reactive hyperemic index
Side effects data
From 2015 Phase 4 trial • 239 Patients • NCT0228827310%
Injection site nodule
7%
Urinary tract infection
7%
Nausea
5%
Injection site induration
5%
Diarrhea
5%
Musculoskeletal pain
5%
Hematuria
5%
Proteinuria
3%
Upper respiratory tract infection
3%
Gastroenteritis
3%
Vomiting
3%
Lipase increased
3%
Amylase increased
3%
Glycosuria
3%
Anemia
2%
Acute Pancreatitis
2%
Nephrolithiasis
2%
Bronchitis
2%
Chest Pain
2%
Non-Cardiac Chest Pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo + Met
EQW + Met
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
1,389 Total Patients Enrolled
Peter D Reaven, MDPrincipal InvestigatorCarl T. Hayden Medical Research Foundation
5 Previous Clinical Trials
1,583 Total Patients Enrolled