Glucagon Rescue of Insulin-Induced Hypoglycemia in Adults With Type 1 Diabetes Treated With Volagidemab
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Change in Time to glucagon treatment success at Week 6.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 72 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
35 mg Volagidemab
Volagidemab 35 mg will be administered by subcutaneous (SC) injection once weekly for 6 weeks.
干预措施: Volagidemab (Biological)
结局指标
主要结局
Change in Time to glucagon treatment success at Week 6.
时间窗: 6 weeks
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.
次要结局
- Blood glucose response to glucagon rescue treatment during insulin-induced hypoglycemia.(6 weeks)
- Hypoglycemia symptoms - Clarke Survey(6 weeks)
- Treatment emergent adverse events (AEs)(12 weeks)
- Hypoglycemia symptoms - Gold Questionnaire(6 weeks)
- Hypoglycemia symptoms - Edinburgh Hypoglycemia Scale(6 weeks)
- Change from baseline in hemoglobin A1c (HbA1c) at Week 6.(6 weeks)