A Stable Glucagon Analog Administered by a Bihormonal Closed Loop System; a Feasibility Study
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Time in range
研究概览
简要总结
The main objective is to determine the feasibility of dasiglucagon in a bi-hormonal reactive closed loop system for automated glucose regulation (artificial pancreas; AP®) in patients with diabetes mellitus type 1. Safety parameters and pharmacodynamics are compared between Dasiglucagon and GlucaGen®.
This study is a single-center, double-blinded, randomized, cross over trial in 12 subjects. The subjects will be randomized to receive either dasiglucagon or GlucaGen® for the first three day study period and switch to the alternate treatment after a wash-out treatment.
详细描述
Background of the study:
Inreda Diabetic B.V. (Goor, The Netherlands) developed a bi-hormonal reactive closed loop system to automate glucose regulation (artificial pancreas; AP) in patients with diabetes mellitus type 1. In the current CE-marked AP, GlucaGen® (Novo Nordisk, Denmark) is used as glucagon. This glucagon formulation is not stable and therefore fibrillation and infusion set occlusion could occur, resulting in reduced glucagon action with risk for hypoglycemia. Dasiglucagon (Zealand Pharma, Denmark) is a glucagon analog stable in aqueous solution and does therefore not suffer from fibrillation.
Objective of the study:
The main objective is to determine the feasibility of dasiglucagon in the Inreda AP-system. Secondary objectives are to assess safety parameters, differences in pharmacodynamics between dasiglucagon and GlucaGen® and differences in AP related outcomes.
Study design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Investigational Medicinal Product dasiglucagon and control GlucaGen are masked as either treatment A or B. Only the assistant researcher who does the preparation and allocation of the drugs has this key.
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
- •Diagnosed with diabetes mellitus type 1;
- •Treated with the Inreda AP system for a minimum of 1 month;
- •Age between 18 and 75 years;
- •Adequate contraception is required (only applicable for female participants);
- •Willing and able to sign informed consent.
- •Since subjects are treated with the Inreda AP, the following inclusion criteria will be met:
- •Treated with SAP or CSII for a minimum of 6 months;
- •HbA1c < 97 mmol/mol;
- •BMI < 35 kg/m2;
- •No use of acetaminophen, as this may influence the sensor glucose measurements.
排除标准
- •Impaired awareness of hypoglycemia (score ≥ 4) according to Gold and/or Clarke questionnaire [3], [4];
- •Pregnancy and/or breastfeeding;
- •Use of oral antidiabetic agents;
- •Pheochromocytoma;
- •Insulinoma;
- •Severe liver/heart/renal failure;
- •Alcohol abuse;
- •Hypersensitivity reactions to dasiglucagon, glucagon or any of the excipients;
研究组 & 干预措施
Dasiglucagon
Dasiglucagon 1mg/ml solution for subcutaneous injection. Size and frequency of dosing will be determined by the AP algorithm. Duration: 3 days.
干预措施: Dasiglucagon (Drug)
GlucaGen
Glucagon 1mg/ml solution for subcutaneous injection. Size and frequency of dosing will be determined by the AP algorithm. Duration: 3 days.
干预措施: GlucaGen (Drug)
结局指标
主要结局
Time in range
时间窗: 3 days
Time of glucose concentration in the range 3.9-10.0 mmol/L in %
次要结局
- Pharmacodynamics - PD curves(3 days)
- Pharmacodynamics - glycemic variability(3 days)
- Extra food intakes (food intake diary)(3 days)
- AP related parameters - doses(3 days)
- Side effects(3 days)
- Pharmacodynamics - hypo/hyper(3 days)
- Pharmacodynamics - glucose value(3 days)
- AP related parameters - algorithm(3 days)