A Phase 3b, Randomized, Double-blind, Crossover Trial to Compare the Efficacy and Safety of 2 Different Batches of Subcutaneous Dasiglucagon in Patients With Type 1 Diabetes Mellitus
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Time to plasma glucose recovery
研究概览
简要总结
A randomized, double-blind, crossover trial to compare the efficacy and safety of 2 different batches of subcutaneous dasiglucagon in patients with type 1 diabetes mellitus (T1DM)
详细描述
This multicenter, double-blind, crossover, randomized clinical trial was designed to evaluate the efficacy and safety of 2 different batches of subcutaneous dasiglucagon in patients with T1DM. Patients were randomly assigned 1:1 to either dasiglucagon Batch A or dasiglucagon Batch B as their initial dose and the other as the second dose. To avoid bias in the evaluation of clinical assessments, the trial was conducted in a double-blinded manner.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Type 1 diabetes mellitus for at least 1 year according to the diagnostic criteria as defined by the American Diabetes Association.
- •Hemoglobin A1c <10.0% at screening
- •Treated with stable insulin treatment (defined as no more than a 10-unit daily variation in total daily insulin dose) 30 days prior to screening
排除标准
- •History of hypoglycemic events associated with seizures in the last year prior to screening
- •History of severe hypoglycemia (an episode requiring assistance from another person) in the last month prior to screening
- •Previous participation in a clinical trial within the dasiglucagon program
研究组 & 干预措施
Dasiglucagon batch A crossover to dasiglucagon batch B
V2: Single fixed dose (subcutaneous injection) of dasiglucagon batch A then at V3: Single fixed dose (subcutaneous injection) of dasiglucagon batch B
干预措施: dasiglucagon (Drug)
Dasiglucagon batch B crossover to dasiglucagon batch A
V2: Single fixed dose (subcutaneous injection) of dasiglucagon batch B then at V3: Single fixed dose (subcutaneous injection) of dasiglucagon batch A
干预措施: dasiglucagon (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 is 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 glucose
次要结局
- Pharmacodynamics - Maximum plasma glucose concentration(0-90 minutes after dosing)
- Pharmacokinetics - Area under the plasma concentration-time curve 30 min(0-30 minutes after dosing)
- Pharmacokinetics - Area under the plasma concentration-time curve 300 min(0-300 minutes after dosing)
- Pharmacokinetics - Body clearance(0-300 minutes after dosing)
- Safety - Adverse events(90 days)
- Plasma glucose changes from baseline(0-30 minutes after dosing)
- Pharmacodynamics - Area under the effect curve 30 min(0-30 minutes after dosing)
- Pharmacodynamics - Area under the effect curve 90 min(0-90 minutes after dosing)
- Pharmacokinetics - Maximum plasma concentration(0-300 minutes after dosing)
- Pharmacokinetics - Mean residence time(0-300 minutes after dosing)
- Safety - Number of rescue infusions(0-90 minutes after dosing)
- Pharmacodynamics - Time maximum plasma glucose concentration(0-90 minutes after dosing)
- Pharmacokinetics - Area under the plasma concentration curve Infinitely(0-300 minutes after dosing)
- Safety - Time to first rescue infusion(0-90 minutes after dosing)
- Immunogenicity - Occurrence of anti-drug antibodies(60 days)
- Pharmacokinetics - Time to maximum plasma concentration(0-300 minutes after dosing)
- Pharmacokinetics - Half-life(0-300 minutes after dosing)
- Pharmacokinetics - Volume of distribution(0-300 minutes after dosing)