COMPLETED

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-02-15

Study Completion:2025-02-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06272695

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 72 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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

Inclusion Criteria

Exclusion 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.

* 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

Contacts and Locations

Principal Investigator

Zung Thai, MD

STUDY_DIRECTOR

REMD Biotherapeutics

Study Locations (Sites)

Altman Clinical and Translational Research Institute

San Deigo, California, 92037

United States

Diablo Clinical Research

Walnut Creek, California, 94598

United States

Collaborators and Investigators

Sponsor: REMD Biotherapeutics, Inc.

Zung Thai, MD, STUDY_DIRECTOR, REMD Biotherapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-15

Study Completion Date2025-02-01

Study Record Updates

Study Start Date2024-02-15

Study Completion Date2025-02-01

Terms related to this study

Additional Relevant MeSH Terms

Type 1 Diabetes Mellitus