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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02162550
Recruitment Status : Unknown
Verified June 2018 by Peter Reaven, Phoenix VA Health Care System.
Recruitment status was:  Active, not recruiting
First Posted : June 12, 2014
Last Update Posted : June 14, 2018
Sponsor:
Information provided by (Responsible Party):
Peter Reaven, Phoenix VA Health Care System

Tracking Information
First Submitted Date  ICMJE May 27, 2014
First Posted Date  ICMJE June 12, 2014
Last Update Posted Date June 14, 2018
Study Start Date  ICMJE June 2014
Estimated Primary Completion Date April 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2016)
Change in carotid plaque volume [ Time Frame: 18 months ]
To determine the difference in change in carotid plaque volume, using 3 tesla (3T) MRI, between T2DM patients treated with Bydureon or placebo.
Original Primary Outcome Measures  ICMJE
 (submitted: June 10, 2014)
Difference in change in carotid plaque volume [ Time Frame: 18 months ]
To determine the difference in change in carotid plaque volume, using 3T MRI, between T2DM patients treated with Bydureon or placebo.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2016)
  • Change in reactive hyperemic index [ Time Frame: 18 months ]
    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 ]
    To determine the difference in change in carotid plaque composition, using 3 tesla (3T) MRI, between T2DM patients treated with Bydureon or placebo.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2014)
  • Difference in reactive hyperemic index [ Time Frame: 18 months ]
    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.
  • Correlations between blood risk markers and progression of plaque volume and composition [ Time Frame: 18 months ]
    explore potential mechanisms by examining statistical relationships between changes in blood risk markers and progression of plaque volume and composition
  • Correlations between reactive hyperemic index and progression of plaque volume and composition [ Time Frame: 18 months ]
    explore potential mechanisms by examining statistical relationships between changes in reactive hyperemic index and progression of plaque volume and composition
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: June 10, 2014)
difference in change in carotid plaque volume between treatment groups by baseline level of vascular disease [ Time Frame: 18 months ]
difference in change in carotid plaque volume by baseline determinations of vascular disease as assessed by baseline CVD history and carotid plaque volume
 
Descriptive Information
Brief Title  ICMJE Effect of Bydureon on Carotid Atherosclerosis Progression in Type 2 Diabetes Mellitus
Official Title  ICMJE Effect of Bydureon on Carotid Atherosclerosis Progression in T2DM
Brief 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.

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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes
Intervention  ICMJE
  • Drug: Bydureon
    once weekly injection
    Other Name: long-acting exenatide
  • Drug: placebo
    once weekly injection
    Other Name: inactive agent
Study Arms  ICMJE
  • Experimental: Bydureon
    injectable medication Bydureon
    Intervention: Drug: Bydureon
  • Placebo Comparator: Placebo
    a similar looking injectable
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 10, 2014)
148
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2019
Estimated Primary Completion Date April 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02162550
Other Study ID Numbers  ICMJE 1026
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Subject to VA regulation.
Responsible Party Peter Reaven, Phoenix VA Health Care System
Study Sponsor  ICMJE Phoenix VA Health Care System
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Peter D Reaven, MD Carl T. Hayden Medical Research Foundation
PRS Account Phoenix VA Health Care System
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP