Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06272695
Status:
RECRUITING
Last Update Posted:
2024-04-10
First Post:
2024-02-15
Brief Title:
Glucagon Rescue of Insulin-Induced Hypoglycemia in Adults With Type 1 Diabetes Treated With Volagidemab
Sponsor:
REMD Biotherapeutics Inc
Organization:
REMD Biotherapeutics Inc
Study Overview
Official Title:
Glucagon Rescue of Insulin-Induced Hypoglycemia in Adults With Type 1 Diabetes Treated With Volagidemab
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None