Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2026-02-25 @ 6:30 PM
Study NCT ID:
NCT02162550
Status:
UNKNOWN
Last Update Posted:
2018-06-14
First Post:
2014-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Bydureon on Carotid Atherosclerosis Progression in Type 2 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D050197', 'term': 'Atherosclerosis'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077270', 'term': 'Exenatide'}], 'ancestors': [{'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D014688', 'term': 'Venoms'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 148}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2019-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-06-12', 'studyFirstSubmitDate': '2014-05-27', 'studyFirstSubmitQcDate': '2014-06-10', 'lastUpdatePostDateStruct': {'date': '2018-06-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-06-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in carotid plaque volume', 'timeFrame': '18 months', 'description': 'To determine the difference in change in carotid plaque volume, using 3 tesla (3T) MRI, between T2DM patients treated with Bydureon or placebo.'}], 'secondaryOutcomes': [{'measure': 'Change in reactive hyperemic index', 'timeFrame': '18 months', 'description': '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.'}, {'measure': 'Change in carotid plaque composition', 'timeFrame': '18 months', 'description': 'To determine the difference in change in carotid plaque composition, using 3 tesla (3T) MRI, between T2DM patients treated with Bydureon or placebo.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Type 2 Diabetes', 'Cardiovascular Disease', 'Hyperglycemia', 'Carotid Plaque', 'Endothelial function', 'Incretins', 'Atherosclerosis'], 'conditions': ['Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '33495294', 'type': 'DERIVED', 'citation': 'Koska J, Migrino RQ, Chan KC, Cooper-Cox K, Reaven PD. The Effect of Exenatide Once Weekly on Carotid Atherosclerosis in Individuals With Type 2 Diabetes: An 18-Month Randomized Placebo-Controlled Study. Diabetes Care. 2021 Jun;44(6):1385-1392. doi: 10.2337/dc20-2014. Epub 2021 Jan 25.'}]}, 'descriptionModule': {'briefSummary': 'Investigators will be determining whether a once weekly injectable medication Bydureon versus placebo is able to reduce the development of atherosclerosis.\n\nInvestigators 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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* males and females of any race and ethnicity with T2DM, HbA1c of ≥6.5% and ≤10.0% on diet only\n* take stable doses of oral antihyperglycemic agents with or without long-acting insulin\n* 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\n\nExclusion Criteria:\n\n* type 1 diabetes mellitus (T1DM)\n* current or recent glucagon-like peptide 1 receptor (GLP-1R) agonist use\n* contraindications to MRI (e.g., claustrophobia, ferromagnetic materials, body habitus inappropriate for MRI exam)\n* screening carotid ultrasound plaque thickness of \\<0.75 mm, prior or anticipated carotid stenting or endarterectomy\n* 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\n* patients with Multiple Endocrine Neoplasia syndrome type 2\n* serious hypersensitivity to exenatide or any product components\n* severe gastrointestinal disease, or pregnancy"}, 'identificationModule': {'nctId': 'NCT02162550', 'briefTitle': 'Effect of Bydureon on Carotid Atherosclerosis Progression in Type 2 Diabetes Mellitus', 'organization': {'class': 'FED', 'fullName': 'Phoenix VA Health Care System'}, 'officialTitle': 'Effect of Bydureon on Carotid Atherosclerosis Progression in T2DM', 'orgStudyIdInfo': {'id': '1026'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bydureon', 'description': 'injectable medication Bydureon', 'interventionNames': ['Drug: Bydureon']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'a similar looking injectable', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'Bydureon', 'type': 'DRUG', 'otherNames': ['long-acting exenatide'], 'description': 'once weekly injection', 'armGroupLabels': ['Bydureon']}, {'name': 'placebo', 'type': 'DRUG', 'otherNames': ['inactive agent'], 'description': 'once weekly injection', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85012', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Phoenix VA Health Care System', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}], 'overallOfficials': [{'name': 'Peter D Reaven, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Carl T. Hayden Medical Research Foundation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Subject to VA regulation.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Phoenix VA Health Care System', 'class': 'FED'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Diabetes Program', 'investigatorFullName': 'Peter Reaven', 'investigatorAffiliation': 'Phoenix VA Health Care System'}}}}