A Randomised, Double-blind, Three-period Crossover Trial to Investigate the Safety and the Pharmacokinetic, Pharmacodynamic Characteristics of Two BioChaperone® Glucagon Formulations Compared to Marketed GlucaGen® in Subjects With Type 1 Diabetes
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Adocia
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Clinical safety laboratory
研究概览
简要总结
This is a single centre, double-blind, randomised, three-period crossover phase 1 trial in subjects with type 1 diabetes mellitus (T1DM). Each subject will be randomly allocated to a sequence of three treatments, i.e. two single subcutaneous doses of BioChaperone® Glucagon (BC Glucagon) formulation 1, BioChaperone® Glucagon formulation 2 and GlucaGen® HypoKit®, each at the fixed doses of 50 µg and 1 mg on 3 separate dosing visits.
Following trial drug administration, pharmacokinetics (PK) and pharmacodynamics (PD) assessments will be carried until 4 hours. Safety will be assessed during all the trial period.
The total trial maximum duration for the individual subject will be up to 10 weeks.
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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients aged between 18 and 64 years (both inclusive)
- •Type 1 diabetes mellitus (as diagnosed clinically) ≥ 12 months prior to the screening visit
- •Treated with daily insulin for T1DM ≥ 12 months prior to the screening visit
- •Stable insulin treatment at least 3 months prior to the screening visit
- •Stable disease with HbA1c <9.0 %
- •C peptide <=0.30 nmol/L
- •Body mass index (BMI) < 30.0 kg/m2
排除标准
- •Type 2 Diabetes mellitus
- •Previous participation in this trial. Participation is defined as being randomised
- •Receipt of any medicinal product in clinical development within 60 days prior to this trial
- •Clinically significant abnormal haematology, biochemistry, urinalysis, or coagulation screening tests, as judged by the Investigator considering the underlying disease
- •Known or suspected hypersensitivity to the trial products or related products
- •Severe hypoglycaemic events within one month prior to screening, as judged by the investigator
- •Recent administration of glucagon (within 3 months prior to Screening)
- •Clinically relevant diabetic complications as judged by the investigator
- •Women of child bearing potential not willing to use contraceptive methods
研究组 & 干预措施
BioChaperone® glucagon formulation 1
Single subcutaneous fixed doses (50 µg and 1.0 mg)
干预措施: BioChaperone® glucagon formulation 1 (Drug)
BioChaperone® glucagon formulation 2
Single subcutaneous fixed doses (50 µg and 1.0 mg)
干预措施: BioChaperone® glucagon formulation 2 (Drug)
GlucaGen® HypoKit®
Single subcutaneous fixed doses (50 µg and 1.0 mg)
干预措施: GlucaGen® HypoKit® (Drug)
结局指标
主要结局
Clinical safety laboratory
时间窗: Up to 10 weeks
Haematology, biochemistry and urinalysis: changes or findings from baseline in clinical safety laboratory parameters during the trial duration (screening visit, treatment visits and follow up visit)
Assessments of local tolerability at injection site
时间窗: Up to 10 weeks
Local reaction at injection site
Physical examination
时间窗: Up to 10 weeks
Examination of the body systems
ECG parameters
时间窗: Up to 10 weeks
Heart rate, PQ, QRS, QT, QTcB: changes or findings from baseline in ECG parameters during the trial duration (screening visit, treatment visits and follow up visit)
Vital signs
时间窗: Up to 10 weeks
Diastolic and systolic blood pressure (mmHg), Pulse (beats/min), Body temperature (°C), Respiratory frequency (RF/min): changes or findings from baseline in vital signs during the trial duration (screening visit, treatment visits and follow up visit)
Adverse events and serious adverse events
时间窗: Up to 10 weeks
Untoward medical occurrence
次要结局
- ΔAUCPG 0-30min(From 0 to 30 min)
- AUCPK 0-30min(From 0 to 30 min)
- AUC PK 0-4h(From 0 to 4 hours)
- ΔAUCPG 0-4h(From 0 to 4 hours)
- ΔPG 30min(From 0 to 30 min)
- Percentage of patients achieving a plasma glucose increase of ≥20 mg/dL from baseline within 30 minutes after treatment(30 min after drug administration)
- Time to plasma glucose increase of ≥20 mg/dL from baseline(Up to 4 hours after drug administration)