Ignite Creation Date:
2025-12-24 @ 9:47 PM
Ignite Modification Date:
2025-12-25 @ 7:26 PM
Study NCT ID:
NCT04355832
Status:
WITHDRAWN
Last Update Posted:
2025-11-07
First Post:
2020-04-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Glucagon-like Peptide-1 in Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D052216', 'term': 'Glucagon-Like Peptide 1'}], 'ancestors': [{'id': 'D004763', 'term': 'Glucagon-Like Peptides'}, {'id': 'D052336', 'term': 'Proglucagon'}, {'id': 'D005768', 'term': 'Gastrointestinal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'We were unable to obtain GLP-1', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-06-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-09-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-05', 'studyFirstSubmitDate': '2020-04-17', 'studyFirstSubmitQcDate': '2020-04-17', 'lastUpdatePostDateStruct': {'date': '2025-11-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-04-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the level of catecholamines in plasma', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type1 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The hypotheses to be tested in this application is: GLP-1 will acutely protect arterial endothelial function and reduce pro-atherothrombotic and pro-coagulant effects of repeated hypoglycemia in T1DM.', 'detailedDescription': 'The naturally occurring hormone GLP-1 when co-administered during hypoglycemia (low blood sugar) in non-diabetic individuals can reduce the deleterious effects of hypoglycemia on the vasculature. We have shown that IV infusion of GLP-1 during a single moderate episode of hypoglycemia can preserve endothelial function and protect the vasculature from pro-coagulant and pro-inflammatory effects in healthy individuals.\n\nIt is unknown whether GLP-1 could protect the vasculature during episodes of repeated hypoglycemia and whether GLP-1 would have protective effects in T1DM individuals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 40 (20 males, 20 females) individuals with type 1 diabetes aged 18-50 yr.\n* HbA1c \\< 11.0%\n* Body mass index \\< 40kg • m-2\n* No clinically diagnosed diabetic tissue complications (i.e. history of retinopathy, neuropathy, stasis ulcers, etc)\n\nExclusion Criteria:\n\n* Subjects unable to give voluntary informed consent\n* Pregnancy\n* Subjects on anticoagulant drugs, anemic or with known bleeding diatheses\n* Subjects taking any of the following medications will be excluded: non-selective beta blockers,\n* sedative-hypnotics, anticonvulsants, antiparkinsonian drugs, antipsychotics, antidepressants,\n* mood stabilizers, CNS stimulants, opioids, hallucinogens\n* Subjects unwillingness or inability to comply with approved contraception measures\n* Subjects with a history of severe uncontrolled hypertension (i.e., blood pressure greater than 160/100), heart disease, cerebrovascular incidents\n* Clinically significant cardiac abnormalities (e.g. heart failure, arrhythmias, ischemic tachycardia, S-T segment deviations, etc.) from history or from cardiac stress testing in subjects ≥ 40 years old.\n* Pneumonia\n* Hepatic failure /jaundice\n* Abnormal results following screening tests and physical examination that are clinically significant\n* Acute cerebrovascular/ neurological deficit\n* Fever greater than 38.0 C\n* Screening Laboratory Tests Exclusion Criteria\n* Hematocrit lower than 32\n* WBC lower than 3 thou/ul or greater than 14 thou/ul\n* Liver function tests: SGOT and SGPT greater than twice upper limit of normal range (i.e. \\> 80 U/L)\n* TBil \\> 2 mg/dl\n* Creatinine \\> 1.6 mg/dl\n* Alkaline phosphatase \\> 150U/L\n* Hepatic transaminase \\> 2x normal'}, 'identificationModule': {'nctId': 'NCT04355832', 'briefTitle': 'Glucagon-like Peptide-1 in Type 1 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'University of Maryland, Baltimore'}, 'officialTitle': 'Reducing Hypoglycemic, Pro-coagulant and Pro-atherothrombotic Responses and Preventing Hypoglycemia Associated Autonomic Failure in Type 1 DM. The Effects of Glucagon-like Peptide-1', 'orgStudyIdInfo': {'id': 'HP-00090856'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo 1', 'description': 'The participants will be randomized to placebo infusion.', 'interventionNames': ['Drug: Placebos']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo 2', 'description': 'The participants will be randomized to placebo infusion.', 'interventionNames': ['Drug: Placebos']}, {'type': 'EXPERIMENTAL', 'label': 'GLP-1', 'description': 'The participants will be randomized to Glucagon-like peptide-1 infusion.', 'interventionNames': ['Drug: Glucagon-like peptide-1']}], 'interventions': [{'name': 'Glucagon-like peptide-1', 'type': 'DRUG', 'description': 'Infusion of Glucagon-like peptide-1', 'armGroupLabels': ['GLP-1']}, {'name': 'Placebos', 'type': 'DRUG', 'description': 'Infusion of normal saline solution that will mimic Glucagon-like peptide-1', 'armGroupLabels': ['Placebo 1', 'Placebo 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Maryland, Baltimore', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Stephen N. Davis, MBBS', 'investigatorAffiliation': 'University of Maryland, Baltimore'}}}}