Ignite Creation Date:
2025-12-24 @ 9:57 PM
Ignite Modification Date:
2026-01-29 @ 8:04 AM
Study NCT ID:
NCT02611232
Status:
UNKNOWN
Last Update Posted:
2022-01-25
First Post:
2015-11-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Incretin-based Therapy in Preclinical Type 1 Diabetes in Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], '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': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, '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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 42}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-07', 'studyFirstSubmitDate': '2015-11-18', 'studyFirstSubmitQcDate': '2015-11-19', 'lastUpdatePostDateStruct': {'date': '2022-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'FPIR (first phase insulin response)', 'timeFrame': 'From baseline to 26 and 104 weeks', 'description': 'First phase insulin response during 10-min IVGTT (intravenous glucose tolerance test )'}], 'secondaryOutcomes': [{'measure': 'Safety: serum and urine amylase, serum lipase, serum calcitonin, hypoglycemia', 'timeFrame': 'From baseline to 26 and 104 weeks', 'description': 'Safety: serum and urine amylase, serum lipase, serum calcitonin, hypoglycemia'}, {'measure': 'Tolerability', 'timeFrame': 'From baseline to 26 and 104 weeks', 'description': 'Tolerability: frequency of side effects, particularly hypoglycaemia and gastrointestinal symptoms'}, {'measure': 'Serum C-peptide AUC', 'timeFrame': 'From baseline to 26 and 104 weeks', 'description': 'Serum C-peptide area under the curve (AUC) during 2-hour OGTT (oral glucose tolerance test)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Diabetes Type 1', 'Diabetes, Insulin-Dependent', 'Liraglutide', 'Preclinical Type 1 Diabetes', 'GLP-1 Analogue'], 'conditions': ['Type 1 Diabetes']}, 'referencesModule': {'references': [{'pmid': '35797241', 'type': 'DERIVED', 'citation': 'Kero J, Koskenniemi JJ, Karsikas S, Pokka T, Lou O, Toppari J, Veijola R. INnoVative trial design for testing the Efficacy, Safety and Tolerability of 6-month treatment with incretin-based therapy to prevent type 1 DIAbetes in autoantibody positive participants: A protocol for three parallel double-blind, randomised controlled trials (INVESTDIA). Diabet Med. 2022 Oct;39(10):e14913. doi: 10.1111/dme.14913. Epub 2022 Jul 22.'}]}, 'descriptionModule': {'briefSummary': 'The main objectives of the trial are to study whether daily treatment with liraglutide improves insulin secretion and glucose metabolism, and whether liraglutide treatment is tolerable and safe in subjects with preclinical type 1 diabetes aged 18-30 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-30 years of age\n* positive for at least 2 biochemical islet autoantibodies\n* have normal glucose tolerance in OGTT\n* are not pregnant\n\nExclusion Criteria:\n\n* allergic to liraglutide or other ingredients of Victoza®\n* Type 1 diabetes\n* diabetic ketoacidosis\n* previous treatment in the last three months with any antidiabetic medication\n* impaired liver or kidney function or on dialysis\n* severe heart failure\n* severe stomach or gut problem resulting in gastroparesis, or inflammatory bowel disease\n* past or current history of pancreatitis\n* serum calcitonin value above normal (\\>50 ng/l or ≥3.4pmol/l)\n* presence of any chronic metabolic, hematologic or malignant disease\n* obesity BMI ≥30\n* pregnant females and females of childbearing potential who are not using adequate contraceptive methods.\n* breast-feeding'}, 'identificationModule': {'nctId': 'NCT02611232', 'briefTitle': 'Incretin-based Therapy in Preclinical Type 1 Diabetes in Adults', 'organization': {'class': 'OTHER', 'fullName': 'University of Oulu'}, 'officialTitle': 'Incretin-based Therapy in Preclinical Type 1 Diabetes in Adults', 'orgStudyIdInfo': {'id': 'LiraAAB18-30'}, 'secondaryIdInfos': [{'id': '2014-003667-37', 'type': 'EUDRACT_NUMBER'}, {'id': '3-SRA-2014-301-M-R', 'type': 'OTHER_GRANT', 'domain': 'Juvenile Diabetes Research Foundation International'}, {'id': 'U1111-1176-6062', 'type': 'OTHER', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Victoza®', 'description': 'Subjects with preclinical type 1 diabetes aged 18-30 years are treated with Victoza® (liraglutide)', 'interventionNames': ['Drug: Victoza®']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Subjects with preclinical type 1 diabetes aged 18-30 years are treated with placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Victoza®', 'type': 'DRUG', 'description': 'Daily subcutaneous injections with increasing doses up to 1.8 mg per day. Duration of treatment 6 months. Duration of follow-up 24 months.', 'armGroupLabels': ['Victoza®']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Daily subcutaneous injections with increasing doses up to 1.8 mg per day. Duration of treatment 6 months. Duration of follow-up 24 months.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90029', 'city': 'Oulu', 'country': 'Finland', 'facility': 'University of Oulu and Oulu University Hospital', 'geoPoint': {'lat': 65.01236, 'lon': 25.46816}}, {'zip': '33521', 'city': 'Tampere', 'country': 'Finland', 'facility': 'University of Tampere and Tampere University Hospital', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}, {'zip': '20520', 'city': 'Turku', 'country': 'Finland', 'facility': 'University of Turku and Turku University Hospital', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}], 'overallOfficials': [{'name': 'Riitta Veijola, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Oulu'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oulu', 'class': 'OTHER'}, 'collaborators': [{'name': 'Oulu University Hospital', 'class': 'OTHER'}, {'name': 'Tampere University Hospital', 'class': 'OTHER'}, {'name': 'Turku University Hospital', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Riitta Veijola', 'investigatorAffiliation': 'University of Oulu'}}}}