Ignite Creation Date:
2025-12-24 @ 7:06 PM
Ignite Modification Date:
2026-02-20 @ 1:31 PM
Study NCT ID:
NCT00766857
Status:
COMPLETED
Last Update Posted:
2015-12-09
First Post:
2008-10-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Exenatide in Type 2 Diabetic Patients With Congestive Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], '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': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077270', 'term': 'Exenatide'}, {'id': 'D000069036', 'term': 'Insulin Glargine'}], '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'}, {'id': 'D049528', 'term': 'Insulin, Long-Acting'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-08', 'studyFirstSubmitDate': '2008-10-03', 'studyFirstSubmitQcDate': '2008-10-03', 'lastUpdatePostDateStruct': {'date': '2015-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiac Magnetic Resonance (CMR) will be used to assess global cardiac function (LV ejection fraction).', 'timeFrame': 'week -2 and week 11'}], 'secondaryOutcomes': [{'measure': 'Cardiac oxygen consumption, cardiac efficiency and stress perfusion will be assessed by Positron Emission Tomography (PET) using 11C-acetate and H2-15O', 'timeFrame': 'week -2 and week 26'}, {'measure': 'Cardiac function, dimensions and scarring will be measured bij CMR', 'timeFrame': 'week -2 and week 26'}, {'measure': 'Myocardial diastolic function parameters will be obtained bij trans thoracal echocardiography. Comparisons will be made of strain and torsion measures obtained bij CMR and echocardiography.', 'timeFrame': 'week -2 and week 26'}, {'measure': 'Exercise capacity and performance will be assessed by a 6-minute walking test', 'timeFrame': 'week -1 and week 27'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Exenatide', 'Type 2 diabetes mellitus', 'Congestive heart failure', 'Incretin hormones', 'GLP-1 agonist', 'Cardiac metabolism', 'Insulin resistance', 'Cardiac MRI'], 'conditions': ['Type 2 Diabetes Mellitus', 'Congestive Heart Failure']}, 'referencesModule': {'references': [{'pmid': '28526033', 'type': 'DERIVED', 'citation': 'Chen WJY, Diamant M, de Boer K, Harms HJ, Robbers LFHJ, van Rossum AC, Kramer MHH, Lammertsma AA, Knaapen P. Effects of exenatide on cardiac function, perfusion, and energetics in type 2 diabetic patients with cardiomyopathy: a randomized controlled trial against insulin glargine. Cardiovasc Diabetol. 2017 May 19;16(1):67. doi: 10.1186/s12933-017-0549-z.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if exenatide will improve global cardiac function in patients with type 2 diabetes mellitus and congestive heart failure, by favorable effects on cardiac metabolism leading to improvement of cardiac efficiency.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes mellitus\n* Male and postmenopausal female\n* Age 18 years an above\n* Metformin therapy (stable, maximum tolerable dose for 2 months)\n* HbA1c 6.5-10%\n* Confirmed congestive heart failure (NHYA functional class II-IV)\n* Ejection fraction \\< 50%\n* Patients should receive a stable standard therapy for their cardiac condition for 3 months prior entering the study\n\nExclusion Criteria:\n\n* Type 1 diabetes mellitus\n* Serious renal or liver impairment\n* (Receiving treatment for) malignant disease\n* Cardiovascular event \\< 3 months prior to inclusion\n* Acute congestive heart failure\n* Any reason for not being able to sustain the imaging studies\n* Pacemaker/ICD\n* Contraindications for the use of exenatide/ insulin\n* Use of insulin, thiazolidinediones, incretin-based therapies within 4 months of screening\n* Chronic use of glucocorticoids, NSAIDs or centrally acting drugs (\\> 2 weeks) within 2 weeks immediately prior to screening'}, 'identificationModule': {'nctId': 'NCT00766857', 'briefTitle': 'Effects of Exenatide in Type 2 Diabetic Patients With Congestive Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'Amsterdam UMC, location VUmc'}, 'officialTitle': 'The Effect of Exenatide Compared to Insulin Glargine on Cardiac Function and Metabolism in Type 2 Diabetic Patients With Congestive Heart Failure: a Randomized Comparator-controlled Trial', 'orgStudyIdInfo': {'id': 'DC2008exe001'}, 'secondaryIdInfos': [{'id': 'EudraCT: 2008-005325-10'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1. Exenatide', 'interventionNames': ['Drug: exenatide']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2. Insulin glargine', 'interventionNames': ['Drug: Insulin glargine']}], 'interventions': [{'name': 'exenatide', 'type': 'DRUG', 'otherNames': ['exenatide-Byetta'], 'description': 'Exenatide 5 mcg BID for 4 weeks, subsequently increased to 10 mcg BID for the remainder of the study (total of 26 weeks).', 'armGroupLabels': ['1. Exenatide']}, {'name': 'Insulin glargine', 'type': 'DRUG', 'otherNames': ['insulin glargine-Lantus'], 'description': 'Insulin glargine will be initiated at 10 IU QD, titrated according to fasting blood glucose concentrations based on general protocol-defined guidance.', 'armGroupLabels': ['2. Insulin glargine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1081', 'city': 'Amsterdam', 'state': 'North Holland', 'country': 'Netherlands', 'facility': 'VU University Medical Center', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'overallOfficials': [{'name': 'Michaela Diamant, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VUMC Diabetes Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amsterdam UMC, location VUmc', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'M.H.H. Kramer', 'investigatorAffiliation': 'Amsterdam UMC, location VUmc'}}}}