Using volagidemab to improve glucagon response in adults with type 1 diabetes
Glucagon Rescue of Insulin-Induced Hypoglycemia in Adults With Type 1 Diabetes Treated With Volagidemab
This study tests if a new medication called volagidemab can help adults with type 1 diabetes recover better from low blood sugar episodes.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 72 Years |
| Sex | All |
| Sponsor | REMD Biotherapeutics, Inc. Industry-sponsored |
| Drugs / interventions | volagidemab |
| Locations | 2 sites (San Diego, California and 1 other locations) |
| Trial ID | NCT06272695 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effects of volagidemab, a glucagon receptor antagonist, on glucose recovery from hypoglycemia in adults with type 1 diabetes. Participants will receive weekly subcutaneous doses of volagidemab for six weeks, followed by assessments of their hypoglycemia recovery. The study aims to determine if treatment with volagidemab can enhance the effectiveness of glucagon rescue during hypoglycemic episodes. Approximately 24 subjects will be enrolled and monitored over a 12-week period.
Who should consider this trial
Good fit: Ideal candidates are adults with type 1 diabetes who have been on a stable insulin regimen for at least 8 weeks and use continuous glucose monitoring.
Not a fit: Patients with a history of type 2 diabetes, certain pancreatic conditions, or those not meeting the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve recovery from hypoglycemia in adults with type 1 diabetes, enhancing their safety and quality of life.
How similar studies have performed: While this approach is novel, similar studies exploring glucagon receptor antagonism have shown promise in related contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * History of type 2 diabetes, maturity onset diabetes of the young (MODY), pancreatic surgery or chronic pancreatitis * 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 * Myocardial infarction, unstable angina, revascularization procedure, or cerebrovascular accident ≤12 weeks * Indication of liver disease * Current signs and symptoms of anemia * 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. * Treatment with systemic corticosteroids within 30 days of Day 1, or planned initiation of such therapy during the study. * Medical history of cancer or treatment for cancer in the last five years * Women who are pregnant, nursing, or who plan to become pregnant while in the trial * Other exclusion criteria may apply
Where this trial is running
San Diego, California and 1 other locations
- Altman Clinical and Translational Research Institute — San Diego, California, United States (Not_yet_recruiting)
- Diablo Clinical Research — Walnut Creek, California, United States (Recruiting)
Study contacts
- Study coordinator: Zung Thai, MD
- Email: zungthai@remdbio.com
- Phone: 415-225-9338
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.