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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2016 by Phoenix VA Health Care System
Sponsor:
Information provided by (Responsible Party):
Peter Reaven, Phoenix VA Health Care System
ClinicalTrials.gov Identifier:
NCT02162550
First received: May 27, 2014
Last updated: May 2, 2016
Last verified: May 2016
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
Drug: Bydureon
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Bydureon on Carotid Atherosclerosis Progression in T2DM

Resource links provided by NLM:


Further study details as provided by Phoenix VA Health Care System:

Primary Outcome Measures:
  • Change in carotid plaque volume [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    To determine the difference in change in carotid plaque volume, using 3 tesla (3T) MRI, between T2DM patients treated with Bydureon or placebo.


Secondary Outcome Measures:
  • Change in reactive hyperemic index [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    To determine the difference in change in carotid plaque composition, using 3 tesla (3T) MRI, between T2DM patients treated with Bydureon or placebo.


Estimated Enrollment: 148
Study Start Date: June 2014
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bydureon
injectable medication Bydureon
Drug: Bydureon
once weekly injection
Other Name: long-acting exenatide
Placebo Comparator: Placebo
a similar looking injectable
Drug: placebo
once weekly injection
Other Name: inactive agent

Detailed 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.
  Eligibility

Ages Eligible for Study:   21 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02162550

Contacts
Contact: Rubin Ramos 602-277-5551 ext 5812 Rubin.Ramos@va.gov
Contact: Linda McDonald, RN 602-277-5551 ext 7063 Linda.McDonald@va.gov

Locations
United States, Arizona
Phoenix VA Health Care System Recruiting
Phoenix, Arizona, United States, 85012
Principal Investigator: Peter D. Reaven, MD         
Sponsors and Collaborators
Phoenix VA Health Care System
Investigators
Principal Investigator: Peter D Reaven, MD Carl T. Hayden Medical Research Foundation
  More Information

Responsible Party: Peter Reaven, Director, Diabetes Program, Phoenix VA Health Care System
ClinicalTrials.gov Identifier: NCT02162550     History of Changes
Other Study ID Numbers: 1026 
Study First Received: May 27, 2014
Last Updated: May 2, 2016
Health Authority: United States: Federal Government

Keywords provided by Phoenix VA Health Care System:
Type 2 Diabetes
Cardiovascular Disease
Hyperglycemia
Carotid Plaque
Endothelial function
Incretins
Atherosclerosis

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Atherosclerosis
Carotid Artery Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on August 25, 2016