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

Type 2 Diabetes Clinical Trial

Official title:

Effect of Bydureon on Carotid Atherosclerosis Progression in T2DM

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02162550
• Other study ID #: 1026
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: June 2014
• Est. completion date: September 2019

Study information

• Verified date: June 2018
• Source: Phoenix VA Health Care System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Description:

148 typical T2DM patients (ages 21-75) will participate in a rolling recruitment over approximately 2.25 years and be randomly allocated for 18 months to Bydureon (2 mg/week) or matching placebo subcutaneous injections 1x/week in a 2:1 ratio. Participants are expected to have a wide range of cardiovascular (CVD) risk and will therefore allow us to explore the importance of disease extent at baseline as a predictor of response. Blocked randomization will be used to ensure equal distribution of gender and CVD history. Carotid plaque MRI assessments will be performed at baseline, 9 and 18 months.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 148
• Est. completion date: September 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Carotid Artery Diseases
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Bydureon
once weekly injection
• placebo
once weekly injection

Locations

Country	Name	City	State
United States	Phoenix VA Health Care System	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Phoenix VA Health Care System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in reactive hyperemic index	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.	18 months
Secondary	Change in carotid plaque composition	To determine the difference in change in carotid plaque composition, using 3 tesla (3T) MRI, between T2DM patients treated with Bydureon or placebo.	18 months