Ignite Creation Date:
2025-12-24 @ 1:13 PM
Ignite Modification Date:
2026-03-01 @ 3:22 PM
Study NCT ID:
NCT06272695
Status:
COMPLETED
Last Update Posted:
2025-06-03
First Post:
2024-02-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Glucagon Rescue of Insulin-Induced Hypoglycemia in Adults With Type 1 Diabetes Treated With Volagidemab
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': 'C000629677', 'term': 'volagidemab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-28', 'studyFirstSubmitDate': '2024-02-15', 'studyFirstSubmitQcDate': '2024-02-15', 'lastUpdatePostDateStruct': {'date': '2025-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Time to glucagon treatment success at Week 6.', 'timeFrame': '6 weeks', 'description': 'The primary outcome of the study is the change in time to glucagon treatment success, defined as an increase in plasma glucose of ≥20 mg/dL from the glucose nadir after receiving glucagon during insulin-induced hypoglycemia, from baseline to Week 6.'}], 'secondaryOutcomes': [{'measure': 'Blood glucose response to glucagon rescue treatment during insulin-induced hypoglycemia.', 'timeFrame': '6 weeks', 'description': 'Percentage of subjects achieving glucagon treatment success, defined as an increase in plasma glucose to ≥70 mg/dL or an increase of ≥20 mg/dL from the glucose nadir within 30 minutes of receiving glucagon during insulin-induced hypoglycemia, at Week 6.'}, {'measure': 'Treatment emergent adverse events (AEs)', 'timeFrame': '12 weeks', 'description': 'The subject incidence rates of AEs will be tabulated by system organ class, preferred term, and severity grade for all treatment emergent, serious, treatment related, and serious treatment related AEs.'}, {'measure': 'Hypoglycemia symptoms - Edinburgh Hypoglycemia Scale', 'timeFrame': '6 weeks', 'description': 'Results of the Edinburgh Hypoglycemia Scale will be summarized over Intent-to-Treat (ITT) set using descriptive statistics by visit (baseline, week 6) and timepoint (baseline, t = 15, 30, 45, and 60 min after glucagon administration for Edinburgh Hypoglycemia Scale). Changes from baseline in Edinburgh hypoglycemia scale will be summarized similarly.'}, {'measure': 'Hypoglycemia symptoms - Clarke Survey', 'timeFrame': '6 weeks', 'description': 'Results of the Clarke Survey will be summarized over Intent-to-Treat (ITT) set using descriptive statistics by visit (baseline, week 6). Changes from baseline in Clarke Survey will be summarized similarly.'}, {'measure': 'Hypoglycemia symptoms - Gold Questionnaire', 'timeFrame': '6 weeks', 'description': 'Results of the Gold Questionnaire will be summarized over Intent-to-Treat (ITT) set using descriptive statistics by visit (baseline, week 6). Changes from baseline in Gold Questionnaire will be summarized similarly.'}, {'measure': 'Change from baseline in hemoglobin A1c (HbA1c) at Week 6.', 'timeFrame': '6 weeks', 'description': 'Change from baseline in hemoglobin A1c (HbA1c) at Week 6, after repeated doses of volagidemab'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 1 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'This trial is designed to evaluate the effect of glucagon receptor antagonism by volagidemab (once weekly) on glucose recovery from hypoglycemia after treatment with glucagon in adults with type 1 diabetes. After informed consent, Screening procedures to establish subject eligibility will be performed within a period of 28 days. Approximately 24 subjects with type 1 diabetes mellitus (T1DM) on stable doses of insulin will be enrolled.\n\nAfter enrollment, subjects will undergo a baseline Hypoglycemia Recovery Procedure (with glucagon rescue). Subjects will then receive volagidemab subcutaneously (SC) once weekly for 6 weeks. At the end of the treatment phase, subjects will undergo a second Hypoglycemia Recovery Procedure. Subjects will be followed for 6 weeks after the last volagidemab dose with a final End-of-Study (EOS) visit during Week 12. The primary outcome will be the change in time to glucagon treatment success at Week 6 versus baseline.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '72 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Receiving insulin for the treatment of documented diagnosis of T1DM for at least 2 years\n* Body Mass Index (BMI) of 18.5 kg/m2 to 35.0 kg/m2\n* On treatment with a stable insulin regimen for at least 8 weeks\n* Currently using a continuous glucose monitoring (CGM) system\n* HbA1c less than or equal to 10.0%\n* Females of non-childbearing potential must be ≥1 year post-menopausal or documented as being surgically sterile. Females of childbearing potential must agree to use two methods of contraception during the entire study and for an additional 3 months after the end of dosing with the investigational product\n* Male subjects must be willing to use clinically acceptable method of contraception during the entire study and for an additional 3 months after the end of the treatment period\n* Other inclusion criteria may apply.\n\nExclusion Criteria:\n\n* History of type 2 diabetes, maturity onset diabetes of the young (MODY), pancreatic surgery or chronic pancreatitis\n* Pancreas, pancreatic islet cells, or renal transplant recipient\n* T1DM treatment with any other antihyperglycemic drug (e.g., metformin, alpha- glucosidase inhibitors, SGLT-2 inhibitors, pramlintide, inhaled insulin, pre-mixed insulins, etc.) within 30 days of Day 1\n* Occurrence of severe hypoglycemia involving coma and/or seizure that required hospitalization or hypoglycemia-related treatment by an emergency physician or paramedic within 3 months prior to Day 1\n* Myocardial infarction, unstable angina, revascularization procedure, or cerebrovascular accident ≤12 weeks\n* Indication of liver disease\n* Current signs and symptoms of anemia\n* Untreated eating disorders such as bulimia or anorexia nervosa\n* History of pancreatitis, pancreatic neuroendocrine tumors or multiple endocrine neoplasia (MEN) or family history of MEN.\n* Treatment with systemic corticosteroids within 30 days of Day 1, or planned initiation of such therapy during the study.\n* Medical history of cancer or treatment for cancer in the last five years\n* Women who are pregnant, nursing, or who plan to become pregnant while in the trial\n* Other exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT06272695', 'briefTitle': 'Glucagon Rescue of Insulin-Induced Hypoglycemia in Adults With Type 1 Diabetes Treated With Volagidemab', 'organization': {'class': 'INDUSTRY', 'fullName': 'REMD Biotherapeutics, Inc.'}, 'officialTitle': 'Glucagon Rescue of Insulin-Induced Hypoglycemia in Adults With Type 1 Diabetes Treated With Volagidemab', 'orgStudyIdInfo': {'id': 'R477-203'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '35 mg Volagidemab', 'description': 'Volagidemab 35 mg will be administered by subcutaneous (SC) injection once weekly for 6 weeks.', 'interventionNames': ['Biological: Volagidemab']}], 'interventions': [{'name': 'Volagidemab', 'type': 'BIOLOGICAL', 'description': 'Administered by SC injection once weekly for 6 weeks', 'armGroupLabels': ['35 mg Volagidemab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92037', 'city': 'San Deigo', 'state': 'California', 'country': 'United States', 'facility': 'Altman Clinical and Translational Research Institute'}, {'zip': '94598', 'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'facility': 'Diablo Clinical Research', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}], 'overallOfficials': [{'name': 'Zung Thai, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'REMD Biotherapeutics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'REMD Biotherapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}