Ignite Creation Date:
2025-12-24 @ 2:17 PM
Ignite Modification Date:
2026-01-02 @ 1:24 PM
Study NCT ID:
NCT04409795
Status:
COMPLETED
Last Update Posted:
2025-02-24
First Post:
2019-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Hypoglycemic Therapy for Monogenic Variant Carriers of the Joslin Medalist Study
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': 'D000068900', 'term': 'Sitagliptin Phosphate'}], 'ancestors': [{'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011719', 'term': 'Pyrazines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-21', 'studyFirstSubmitDate': '2019-11-14', 'studyFirstSubmitQcDate': '2020-05-28', 'lastUpdatePostDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glycated hemoglobin (HbA1c)', 'timeFrame': '3 months and 6 months', 'description': 'Change in HbA1c (%) between the two study groups'}], 'secondaryOutcomes': [{'measure': 'Daily insulin dose', 'timeFrame': '3 months and 6 months', 'description': 'Change in daily insulin dose (units/kg body weight) between the two study groups'}, {'measure': 'Body mass index (BMI)', 'timeFrame': '3 months and 6 months', 'description': 'Change in BMI between the two study groups. Weight and height will be combined to report BMI in kg/m\\^2.'}, {'measure': 'C-peptide', 'timeFrame': '3 months and 6 months', 'description': 'Change in C-peptide (ng/mL) between the two study groups'}, {'measure': 'Total cholesterol', 'timeFrame': '3 months and 6 months', 'description': 'Change in total cholesterol (mg/dL) between the two study groups'}, {'measure': 'Low density lipoprotein (LDL)-cholesterol', 'timeFrame': '3 months and 6 months', 'description': 'Change in LDL-cholesterol (mg/dL) between the two study groups'}, {'measure': 'High density lipoprotein (HDL)-cholesterol', 'timeFrame': '3 months and 6 months', 'description': 'Change in HDL-cholesterol (mg/dL) between the two study groups'}, {'measure': 'Triglycerides', 'timeFrame': '3 months and 6 months', 'description': 'Change in triglycerides (mg/dL) between the two study groups'}, {'measure': 'Area under the plasma concentration versus time curve (AUC) of C-peptide', 'timeFrame': '6 months', 'description': 'Change in AUC of C-peptide between the two study groups, as measured by the hyperglycemic/arginine clamp, at the end of the study'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 1 Diabetes', 'Monogenic Diabetes']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy of adding oral hypoglycemic agents (OHA) to existing insulin treatment in monogenic variant carriers of the Joslin 50-Year Medalist Study ("Medalists"), who are characterized by ≥50 years of insulin-dependent diabetes. Our primary objective is to evaluate whether the presence of human leukocyte antigen (HLA) high-risk alleles for diabetes (DR3 and/or DR4) can affect the effectiveness of OHA in these subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Existing participants in the Joslin 50-Year Medalist Study\n* Residing in the United States\n* Capable of giving informed consent\n* Known detectable C-peptide \\>0.05 ng/mL\n\nExclusion Criteria:\n\n* Known diagnosis of cancer or active inflammatory disease such as rheumatoid arthritis, lupus, and inflammatory bowel disease\n* Recent history of myocardial infarction, angioplasty, bypass surgery, heart failure, angina, stroke, or uncontrolled hypertension\\>160/100 during the past 3 months\n* Known diagnosis of cognitive dysfunction, dementia or Alzheimer's disease\n* Pre-existing liver disease or liver function tests (AST or ALT)\\>3x the upper limit of normal\n* Pre-existing kidney disease (Chronic Kidney Disease Stage IV and below, or estimated glomerular filtration rate\\<45 mL/min/1.73 m2)\n* Active use of immunosuppressants\n* Recipients of prior islet cell or pancreas transplantation\n* Inability to travel due to frailty or health reasons\n* Donated blood within the previous two (2) months"}, 'identificationModule': {'nctId': 'NCT04409795', 'briefTitle': 'Oral Hypoglycemic Therapy for Monogenic Variant Carriers of the Joslin Medalist Study', 'organization': {'class': 'OTHER', 'fullName': 'Joslin Diabetes Center'}, 'officialTitle': 'A Pilot Trial of Adding Oral Hypoglycemic Therapy to Insulin Treatment in Monogenic Variant Carriers of the Joslin 50-Year Medalist Study', 'orgStudyIdInfo': {'id': '2019-76'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'HLA+ Group', 'description': 'Participants who are high-risk HLA-DR3 and/or DR4 (+); monogenic variant (+) with rare exome variant ensemble learner (REVEL) score\\>0.75; and both glutamic acid decarboxylase (GAD65) and islet antigen (IA2) autoantibody (-)', 'interventionNames': ['Drug: Metformin Extended Release Oral Tablet', 'Drug: Sitagliptin']}, {'type': 'OTHER', 'label': 'HLA- Group', 'description': 'Participants who are high-risk HLA-DR3 and DR4 (-); with known or yet unknown monogenic variants with REVEL score\\>0.75; and either GAD65 and IA2 autoantibody (-), or autoantibody (+) with titers close to the cutoff', 'interventionNames': ['Drug: Metformin Extended Release Oral Tablet', 'Drug: Sitagliptin']}], 'interventions': [{'name': 'Metformin Extended Release Oral Tablet', 'type': 'DRUG', 'description': 'Initial oral hypoglycemic agent added to existing insulin treatment', 'armGroupLabels': ['HLA+ Group', 'HLA- Group']}, {'name': 'Sitagliptin', 'type': 'DRUG', 'description': 'Secondary oral hypoglycemic agent added to existing insulin treatment (for those who are intolerant to or unable to achieve glycemic targets with metformin)', 'armGroupLabels': ['HLA+ Group', 'HLA- Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Joslin Diabetes Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'George L. King, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Joslin Diabetes Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Joslin Diabetes Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}