NCT06272695CompletedPhase 1
Glucagon Rescue of Insulin-Induced Hypoglycemia in Adults With Type 1 Diabetes Treated With Volagidemab
Source: ClinicalTrials.gov · Last updated 3 Jun 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (actual)
- First submitted
- 15 Feb 2024
- Start date
- 15 Feb 2024
- Primary completion date
- 1 Feb 2025
- Lead sponsor
- REMD Biotherapeutics, Inc.
- Diseases
- Type 1 diabetes
- NCT number
- NCT06272695
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 24
- From 15 Feb 2024 to the primary completion date, 1 Feb 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Pancreas, pancreatic islet cells, or renal transplant recipient
- T1DM treatment with any other antihyperglycemic drug (e.g., metformin, alpha- glucosidase inhibitors, SGLT-2 inhibitors, pramlintide, inhaled insulin, pre-mixed insulins, etc.) within 30 days of Day 1
- Occurrence of severe hypoglycemia involving coma and/or seizure that required hospitalization or hypoglycemia-related treatment by an emergency physician or paramedic within 3 months prior to Day 1
- Treatment with systemic corticosteroids within 30 days of Day 1, or planned initiation of such therapy during the study.
Other illness
- History of type 2 diabetes, maturity onset diabetes of the young (MODY), pancreatic surgery or chronic pancreatitis
- Myocardial infarction, unstable angina, revascularization procedure, or cerebrovascular accident ≤12 weeks
- Indication of liver disease
- Untreated eating disorders such as bulimia or anorexia nervosa
- History of pancreatitis, pancreatic neuroendocrine tumors or multiple endocrine neoplasia (MEN) or family history of MEN.
- Medical history of cancer or treatment for cancer in the last five years
Other
- Current signs and symptoms of anemia
- Women who are pregnant, nursing, or who plan to become pregnant while in the trial
- Other exclusion criteria may apply
Who the study is looking for
- Receiving insulin for the treatment of documented diagnosis of T1DM for at least 2 years
- Body Mass Index (BMI) of 18.5 kg/m2 to 35.0 kg/m2
- On treatment with a stable insulin regimen for at least 8 weeks
- Currently using a continuous glucose monitoring (CGM) system
- HbA1c less than or equal to 10.0%
- Females of non-childbearing potential must be ≥1 year post-menopausal or documented as being surgically sterile. Females of childbearing potential must agree to use two methods of contraception during the entire study and for an additional 3 months after the end of dosing with the investigational product
- Male subjects must be willing to use clinically acceptable method of contraception during the entire study and for an additional 3 months after the end of the treatment period
- Other inclusion criteria may apply.
Age in the registry: 18 years to 72 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Altman Clinical and Translational Research Institute Coordinator of this site? Confirm its status | San Deigo | United States | Unknown status |
| Diablo Clinical Research Coordinator of this site? Confirm its status | Walnut Creek | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.