A Double-blinded, Randomised, Four-period Crossover Euglycemic Clamp Trial Investigating the Dose-linearity of BioChaperone® Combo 75/25 and the Safety at Three Different Doses in Subjects With Type 2 Diabetes
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Adocia
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Cmax_total
研究概览
简要总结
This is a bicentric, double-blinded, randomised, four-period crossover phase 1 trial, using automated 30-hour euglycemic clamp in subjects with type 2 diabetes mellitus.
详细描述
This is a bicentric, double-blinded, randomised, four-period crossover phase 1 trial, using automated 30-hour euglycemic clamp in subjects with type 2 diabetes mellitus.
Each subject will be randomly allocated to a sequence of four treatments, three single doses of BioChaperone® Combo 75/25 (0.6 U/kg, 0.8 U/kg or 1.0 U/kg) and one single dose of Humalog® Mix25 at 0.8 U/kg on four separate dosing visits.
Subjects will come in a fasted state to the clinical trial centre in the morning of each dosing day and stay at the clinical trial centre until the 30-hour clamp procedures have been terminated.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subject aged 18-70 years (both inclusive)
- •Type 2 diabetes mellitus (as diagnosed clinically) for ≥ 12 months
- •HbA1c level between 6.5% and 9.0 % (both inclusive)
- •Body mass index between 20.0 and 40.0 kg/m2 (both inclusive)
- •Body weight <= 125.0 kg at the screening visit
- •Insulin-treated subjects. Total insulin dose of <= 1.2 (I)U/kg/day
排除标准
- •Type 1 diabetes mellitus
- •Known or suspected hypersensitivity to IMP(s) or related products
- •Previous participation in this trial. Participation is defined as randomised.
- •Receipt of any medicinal product in clinical development within 60 days before randomisation in this trial.
- •Clinically significant abnormal values for haematology, biochemistry, coagulation, or urinalysis as judged by the Investigator considering the underlying disease.
- •Supine blood pressure at screening (after resting for at least 5 min in supine position) outside the range of 90-160 mmHg systolically or 50-95 mmHg diastolically (excluding white-coat hypertension; therefore, if a repeated measurement shows values within the range, the subject can be included in the trial); symptoms of arterial hypotension and/or a heart rate at rest outside the range of 50-90 beats per minute. This exclusion criterion also pertains to subjects being on anti-hypertensives.
- •Women of child bearing potential not willing to use contraceptive methods.
研究组 & 干预措施
BioChaperone® Combo 75/25 at 0.6 U/kg
Single subcutaneous injection of 0.6 U/kg
干预措施: BioChaperone® Combo 75/25 at 0.6 U/kg (Drug)
BioChaperone® Combo 75/25 at 0.8 U/kg
Single subcutaneous dose of 0.8 U/kg
干预措施: BioChaperone® Combo 75/25 at 0.8 U/kg (Drug)
BioChaperone® Combo 75/25 at 1.0 U/kg
Single subcutaneous dose of 1.0 U/kg
干预措施: BioChaperone® Combo 75/25 at 1.0 U/kg (Drug)
Humalog® Mix25 at 0.8 U/kg
Single subcutaneous dose of 0.8 U/kg
干预措施: Humalog® Mix25 at 0.8 U/kg (Drug)
结局指标
主要结局
Cmax_total
时间窗: From 0 to 30 hours
Maximum observed plasma insulin total concentration
AUC last_total
时间窗: From 0 to 30 hours
Area under the plasma insulin concentration-time curve from t=0 to the last measured total insulin plasma concentration above LLOQ. The total insulin concentration is the sum of lispro and basal concentrations.
次要结局
- Adverse Events(Up to 102 days (maximum duration of subject's participation))
- GIRmax (mg/kg/min)(From 0 to 30 hours)
- tGIRmax(From 0 to 30 hours)
- Local tolerability: number of injection site reaction(Up to 102 days (maximum duration of subject's participation))
- Number of hypoglycaemic events in each treatment arm(Up to 102 days (maximum duration of subject's participation))
- AUCGIR 0-last (mg/kg)(From 0 to 30 hours)