Clinical trial NCT06272695: Glucagon Rescue of Insulin-Induced Hypoglycemia in Adults With Type 1 Diabetes Treated With Volagidemab
Official title: Glucagon Rescue of Insulin-Induced Hypoglycemia in Adults With Type 1 Diabetes Treated With Volagidemab
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: REMD Biotherapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2024-02-22
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change in Time to glucagon treatment success at Week 6.
timeFrame: 6 weeks
Secondary outcomes:
measure: Blood glucose response to glucagon rescue treatment during insulin-induced hypoglycemia.
timeFrame: 6 weeks
measure: Treatment emergent adverse events (AEs)
timeFrame: 12 weeks
measure: Hypoglycemia symptoms - Edinburgh Hypoglycemia Scale
timeFrame: 6 weeks
measure: Hypoglycemia symptoms - Clarke Survey
timeFrame: 6 weeks
measure: Hypoglycemia symptoms - Gold Questionnaire
timeFrame: 6 weeks
measure: Change from baseline in hemoglobin A1c (HbA1c) at Week 6.
timeFrame: 6 weeks
Other outcomes:
Locations:
city: San Deigo
country: United States
facility: Altman Clinical and Translational Research Institute
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research
state: California
Study officials:
affiliation: REMD Biotherapeutics
name: Zung Thai, MD
role: STUDY_DIRECTOR
References: