Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-02-23 @ 11:35 AM
Study NCT ID:
NCT02089256
Status:
COMPLETED
Last Update Posted:
2015-04-01
First Post:
2014-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Repeated Administration of Liraglutide on Insulinogenic Indices
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069450', 'term': 'Liraglutide'}], 'ancestors': [{'id': 'D052216', 'term': 'Glucagon-Like Peptide 1'}, {'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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-31', 'studyFirstSubmitDate': '2014-03-13', 'studyFirstSubmitQcDate': '2014-03-14', 'lastUpdatePostDateStruct': {'date': '2015-04-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the glucose-sensitivity of the beta cells', 'timeFrame': 'baseline, first dose, after 3-weeks on treatment', 'description': 'Graded glucose infusion test will be used to create insulin secretion rate- plasma glucose curve. The primary outcome is the change of the slope of the curve from baseline after acute administration of liraglutide compared to the repeated administration (after 3-weeks of treatment).'}], 'secondaryOutcomes': [{'measure': 'Effects on adrenal hormones', 'timeFrame': 'baseline, acute administration, 3 weeks', 'description': 'change in ACTH/cortisol levels and renin / aldosterone levels after acute and repeated administration of liraglutide.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '36800161', 'type': 'DERIVED', 'citation': 'Heinla K, Vasar E, Reppo I, Sedman T, Volke V. GLP-1 Receptor Agonists Induce Growth Hormone Secretion in Healthy Volunteers. Diabetes Ther. 2023 Apr;14(4):777-786. doi: 10.1007/s13300-023-01381-w. Epub 2023 Feb 17.'}, {'pmid': '28379427', 'type': 'DERIVED', 'citation': "Sedman T, Vasar E, Volke V. Tolerance Does Not Develop Toward Liraglutide's Glucose-Lowering Effect. J Clin Endocrinol Metab. 2017 Jul 1;102(7):2335-2339. doi: 10.1210/jc.2017-00199."}, {'pmid': '27300475', 'type': 'DERIVED', 'citation': 'Sedman T, Heinla K, Vasar E, Volke V. Liraglutide Treatment May Affect Renin and Aldosterone Release. Horm Metab Res. 2017 Jan;49(1):5-9. doi: 10.1055/s-0042-109065. Epub 2016 Jun 14.'}]}, 'descriptionModule': {'briefSummary': 'The study investigates the effect of glucagon-like peptide receptor 1 agonist, liraglutide, on insulin secretion. Study hypothesis: the effect of liraglutide on insulin release may change after repeated administration. The effect of liraglutide on insulin release will be tested using graded glucose infusion test (GGIT) in healthy volunteers. GGIT will be performed without medication and repeated 12 hours after first dose of liraglutide and after 3 weeks of treatment with liraglutide.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Weight 50-100 kg\n\nExclusion Criteria:\n\n* Chronic disease\n* Concomitant drug use\n* Pregnancy or lactation\n* Fasting glucose \\>6 mmol/L.'}, 'identificationModule': {'nctId': 'NCT02089256', 'briefTitle': 'Effect of Repeated Administration of Liraglutide on Insulinogenic Indices', 'organization': {'class': 'OTHER', 'fullName': 'University of Tartu'}, 'officialTitle': 'Effect of Repeated Administration of Liraglutide on Insulinogenic Indices', 'orgStudyIdInfo': {'id': 'LI20/1101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Liraglutide', 'description': 'Liraglutide 0.6 mg/day subcutaneously.', 'interventionNames': ['Drug: Liraglutide']}], 'interventions': [{'name': 'Liraglutide', 'type': 'DRUG', 'otherNames': ['Victoza'], 'description': 'Graded glucose infusion test (GGIT)will be performed on baseline. 1 week later treatment with liraglutide 0.6mg/day (injected between 21.00-23.00) will be initiated.\n\nGGIT will be repeated 12 hours after first injection and after 21 days on-treatment (12 hours after last injection).', 'armGroupLabels': ['Liraglutide']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tartu', 'country': 'Estonia', 'facility': 'Tartu University Hospital', 'geoPoint': {'lat': 58.38062, 'lon': 26.72509}}], 'overallOfficials': [{'name': 'Vallo Volke, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Tartu'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Tartu', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Vallo Volke', 'investigatorAffiliation': 'University of Tartu'}}}}