Ignite Creation Date:
2025-12-24 @ 11:52 AM
Ignite Modification Date:
2025-12-25 @ 11:53 AM
Study NCT ID:
NCT01782261
Status:
COMPLETED
Last Update Posted:
2016-10-11
First Post:
2013-01-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Incretin Effect on the Immunological Phenotype
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}], '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': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069450', 'term': 'Liraglutide'}, {'id': 'C502994', 'term': 'saxagliptin'}], '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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-10', 'studyFirstSubmitDate': '2013-01-30', 'studyFirstSubmitQcDate': '2013-01-30', 'lastUpdatePostDateStruct': {'date': '2016-10-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Increase of regulatory FOXP3+ T cells', 'timeFrame': '4 weeks', 'description': 'the effects of incretin based therapy on regulatory FOXP3+ T cells will be measured at baseline and after 4 weeks'}], 'secondaryOutcomes': [{'measure': 'Immunophenotyping', 'timeFrame': '4 weeks', 'description': 'The effect of incretin based therapy on circulating immune cells and cytokine secretion at baseline and after 4 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['autoimmune disease', 'diabetes type 1', 'incretin effect'], 'conditions': ['Type 1 Diabetes']}, 'descriptionModule': {'briefSummary': 'Assessment of the effect of incretin based therapies (Liraglutide and Saxagliptin) on immune cells in healthy subjects and patients with type 1 diabetes', 'detailedDescription': 'Assessment of immunological effects of Saxagliptin and Liraglutide on immune cells of the peripheral blood.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-healthy subjects or patients with type 1 diabetes\n\nExclusion Criteria:\n\n* pregnancy\n* treatment with GLP-1-Analoga (Liraglutide, Exenatide)\n* treatment with DPP4-inhibitor (Sitagliptin, Vildagliptin, Saxagliptin)\n* chronic disease including a long-term medication over 4 weeks per year (except type 1 diabetes)'}, 'identificationModule': {'nctId': 'NCT01782261', 'briefTitle': 'Incretin Effect on the Immunological Phenotype', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Graz'}, 'officialTitle': 'Pilot Study on Incretin Effect on the Immunological Phenotype in Healthy Subjects and in Type 1 Diabetic Subjects', 'orgStudyIdInfo': {'id': 'ADPP004'}, 'secondaryIdInfos': [{'id': '2011-006300-12', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Liraglutide', 'description': 'Liraglutide subcutaneous injection every day. first week 0.6mg, week 2-4 1.2mg.', 'interventionNames': ['Drug: Liraglutide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Saxagliptin', 'description': 'Saxagliptin 5mg tablet by mouth every day for 4 weeks', 'interventionNames': ['Drug: Saxagliptin']}], 'interventions': [{'name': 'Liraglutide', 'type': 'DRUG', 'otherNames': ['Victoza'], 'description': 'once daily subcutaneous injection', 'armGroupLabels': ['Liraglutide']}, {'name': 'Saxagliptin', 'type': 'DRUG', 'otherNames': ['Onglyza'], 'description': 'once daily tablet', 'armGroupLabels': ['Saxagliptin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8036', 'city': 'Graz', 'country': 'Austria', 'facility': 'Medical University Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}], 'overallOfficials': [{'name': 'Thomas R Pieber, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Graz'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Graz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}