Glucagon Rescue of Insulin-Induced Hypoglycemia in Adults With Type 1 Diabetes Treated With Volagidemab - Trial NCT06272695
Access comprehensive clinical trial information for NCT06272695 through Pure Global AI's free database. This Phase 1 trial is sponsored by REMD Biotherapeutics, Inc. and is currently Recruiting. The study focuses on Type 1 Diabetes Mellitus. Target enrollment is 24 participants.
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Study Focus
Sponsor & Location
REMD Biotherapeutics, Inc.
Timeline & Enrollment
Phase 1
Feb 29, 2024
Jun 15, 2025
Primary Outcome
Change in Time to glucagon treatment success at Week 6.
Summary
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06272695
Non-Device Trial