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NCT06272695 · ClinicalTrials.gov registry record · Phase 1
Glucagon Rescue of Insulin-Induced Hypoglycemia in Adults With Type 1 Diabetes Treated With Volagidemab
A Phase 1 study of Type 1 Diabetes Mellitus, sponsored by REMD Biotherapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 2
- Study locations
NCT06272695: Completed Phase 1 study of Type 1 Diabetes Mellitus, sponsored by REMD Biotherapeutics.
NCT06272695 is a Phase 1 study of Type 1 Diabetes Mellitus that has completed, run by REMD Biotherapeutics. The registered enrollment target is 24 participants, below the 172-participant average among 112 other Type 1 Diabetes Mellitus trials with a reported enrollment target (86% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06272695, a Phase 1 study of Type 1 Diabetes Mellitus, has completed, sponsored by REMD Biotherapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- BIOLOGICAL Volagidemab
Study Locations (2)
California
- Altman Clinical and Translational Research Institute - San Deigo
- Diablo Clinical Research - Walnut Creek
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2024-02-15 |
| Est. Completion | 2025-02-01 |
| Phase | Phase 1 |
What the finished NCT06272695 record still lists
NCT06272695 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 172-participant average among 112 other Type 1 Diabetes Mellitus trials with a reported enrollment target (86% lower).
The record links to 1 condition, with Type 1 Diabetes Mellitus appearing as the primary indexed condition, and to 1 intervention - of which Volagidemab is the first listed.
NCT06272695 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT06272695 about?
NCT06272695 is a clinical study titled "Glucagon Rescue of Insulin-Induced Hypoglycemia in Adults With Type 1 Diabetes Treated With Volagidemab". 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 perform...
What is the current status of trial NCT06272695?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2024-02-15. Estimated completion is 2025-02-01.
What conditions does trial NCT06272695 study?
This clinical trial studies the following conditions: Type 1 Diabetes Mellitus.
What interventions are being tested in trial NCT06272695?
The interventions under investigation include: Volagidemab (BIOLOGICAL).
Who is sponsoring clinical trial NCT06272695?
This trial is sponsored by REMD Biotherapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06272695 being conducted?
This trial has 2 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Type 1 Diabetes Mellitus
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06272695's enrollment target sits among peer trials
24 82nd of 112 higher than 29 of 112 other Type 1 Diabetes Mellitus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 1 Diabetes Mellitus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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