A Randomized, Double-blind, Parallel-group Trial to Confirm the Clinical Efficacy and Safety of Dasiglucagon in the Rescue Treatment of Hypoglycemia in Subjects With Type 1 Diabetes Mellitus (T1DM) Compared to Placebo
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 3
- 主要终点
- Time to Plasma Glucose Recovery.
研究概览
简要总结
A randomized, double-blind, parallel-group trial to confirm the clinical efficacy and safety of dasiglucagon in the rescue treatment of hypoglycemia in subjects with type 1 diabetes mellitus (T1DM) compared to placebo
详细描述
Subjects were randomized in a ratio of 3:1 to receive a single subcutaneous dose of dasiglucagon (0.6 mg) or matching placebo. Randomization also determined whether the subject was to be injected in the buttock or deltoid. During the dosing visit (Visit 2), hypoglycemia was induced by a fast-acting insulin glulisine (Apidra®) infusion, and trial drug was administered when the subject's plasma glucose level was 45-60 mg/dL (2.5-3.3 mmol/L). During the insulin-induced hypoglycemia, pharmacokinetic and pharmacodynamic samples were drawn, and plasma glucose levels were monitored closely at site for safety reasons. A rescue glucose infusion could be administered to ameliorate persistent hypoglycemia. Subjects were followed for at least 28 days after dosing to perform an adequate immunogenicity evaluation of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female or male subjects with T1DM for at least 1 year; diagnostic criteria as defined by the American Diabetes Association (3).
- •Treated with insulin for T1DM for at least 1 year and with stable insulin treatment (defined as no more than a 10-unit daily variation in total daily insulin dose) 30 days prior to screening
- •Hemoglobin A1c <10%.
- •Aged between 18 and 75 years, both inclusive.
排除标准
- •Previous participation in a clinical trial within the dasiglucagon in the rescue treatment of hypoglycemia program.
- •Known or suspected allergy to trial drug(s) or related products.
- •History of anaphylaxis or symptoms of severe systemic allergy (such as angioedema).
- •Previous participation in this trial. Participation being defined by signing the informed consent document.
研究组 & 干预措施
Dasiglucagon
single fixed dose (subcutaneous injection) of dasiglucagon
干预措施: Dasiglucagon (Drug)
Placebo
single fixed dose (subcutaneous injection) of placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Time to Plasma Glucose Recovery.
时间窗: 0-45 minutes after dosing
Plasma glucose recovery was defined as first increase in plasma glucose of ≥20 mg/dL (1.1 mmol/L) from baseline during the hypoglycemic clamp procedure without administration of rescue intravenous (IV) glucose. Patients who received rescue IV glucose before 45 minutes and patients not recovering within 45 minutes after dosing were censored at 45 minutes.
次要结局
- Pharmacokinetics - Time to Maximum Plasma Concentration(0-120 minutes after dosing)
- Time to First Rescue Infusion of IV Glucose After Trial Drug Administration(0-45 minutes after dosing)
- Plasma Glucose Recovery After Trial Drug Injection(0-30 minutes after dosing)
- Immunogenicity - Occurrence of Anti-drug Antibodies(58 days)
- Plasma Glucose Changes From Baseline(0-30 minutes after dosing)
- Time to Target Plasma Glucose Concentration(0-45 minutes after dosing)
- Rescue Infusions of IV Glucose After Trial Drug Administration(0-45 minutes after dosing)
- Pharmacodynamics - Area Under the Effect Curve(0-30 minutes after dosing)
- Pharmacokinetics - Area Under the Plasma Concentration Curve(0-120 minutes after dosing)
- Pharmacokinetics - Maximum Plasma Concentration(0-120 minutes after dosing)