protocolSection identificationModule nctId: NCT06272695, orgStudyIdInfo id: R477-203, briefTitle: Glucagon Rescue of Insulin-Induced Hypoglycemia in Adults With Type 1 Diabetes Treated With Volagidemab, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-15, primaryCompletionDateStruct date: 2025-06-15, completionDateStruct date: 2025-06-15, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: REMD Biotherapeutics, Inc., class: INDUSTRY, 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.After 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., conditionsModule conditions: Type 1 Diabetes Mellitus, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Volagidemab, outcomesModule primaryOutcomes measure: Change in Time to glucagon treatment success at Week 6., secondaryOutcomes measure: Blood glucose response to glucagon rescue treatment during insulin-induced hypoglycemia., secondaryOutcomes measure: Treatment emergent adverse events (AEs), secondaryOutcomes measure: Hypoglycemia symptoms - Edinburgh Hypoglycemia Scale, secondaryOutcomes measure: Hypoglycemia symptoms - Clarke Survey, secondaryOutcomes measure: Hypoglycemia symptoms - Gold Questionnaire, secondaryOutcomes measure: Change from baseline in hemoglobin A1c (HbA1c) at Week 6., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 72 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Altman Clinical and Translational Research Institute, status: NOT_YET_RECRUITING, city: San Diego, state: California, zip: 92037, country: United States, contacts name: Schafer Boeder, MD, role: CONTACT, contacts name: Schafer Baoder, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.71533, lon: -117.15726, locations facility: Diablo Clinical Research, status: RECRUITING, city: Walnut Creek, state: California, zip: 94598, country: United States, contacts name: Mark Christiansen, MD, role: CONTACT, email: mchristiansen@diabloclinical.com, contacts name: Mark Christiansen, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.90631, lon: -122.06496, hasResults: False