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NCT06272695

Glucagon Rescue of Insulin-Induced Hypoglycemia in Adults With Type 1 Diabetes Treated With Volagidemab

REMD Biotherapeutics, Inc.·Phase 1·ClinicalTrials.gov·biologicalRecruiting
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Study focus
Disease/Condition
Type 1 Diabetes Mellitus
Drug/Device/Intervention
Volagidemab
Study type
Interventional
Intervention type
biological
Sponsor & location
Primary sponsor
REMD Biotherapeutics, Inc.
Location
San Diego,Walnut Creek, United States of America
Timeline & enrollment
Phase
Phase 1
Start date
Feb 29, 2024
End date
Jun 15, 2025
Enrollment
24 participants
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
Type 1 diabetes mellitusType 1 diabetes mellitus with unspecified complicationsType 1 diabetes mellitus with other specified complicationsType 1 diabetes mellitus without complicationsType 1 diabetes mellitus with multiple complications
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06272695
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.