A Randomised, Single Dose, Double-blind, Double-dummy, Three-period Cross-over Trial to Compare the Pharmacodynamic and Pharmacokinetic Properties of Biochaperone® Combo With Humalog® Mix25 and With Simultaneous Injections of Humalog® and Lantus® 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
- 24
- 试验地点
- 1
- 主要终点
- Area under the glucose infusion rate curve (AUCGIR) 12-30h (mg/kg)
研究概览
简要总结
This is a single centre, randomised, double-blind, double-dummy, 3-treatment, 3-period cross-over, euglycaemic clamp study in subjects with type 2 diabetes on stable insulin treatment. Each subject will be randomly allocated to a treatment sequence and will be administered single subcutaneous doses of 0.8 U/kg Biochaperone® Combo, 0.8 U/kg Humalog® Mix25 or simultaneous subcutaneous injections of 0.2 U/kg Humalog® and 0.6 U/kg Lantus® during three separate dosing visits.
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, Care Provider, Investigator)
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
- •Type 2 diabetes mellitus (as diagnosed clinically) for ≥ 12 months
- •HbA1c levels ≤ 9.0%
- •Total insulin dose of < 1.2 U/kg/day
- •Body mass index between 20.0 and 35.0 kg/m2 (both inclusive)
- •Body weight ≤ 125.0 kg
- •Fasting serum C-peptide ≤ 1 nmol/L
- •Treated with a stable insulin regimen for ≥ 3 months prior to screening
排除标准
- •Type 1 diabetes mellitus
- •Known or suspected allergy to the trial products or related products
- •Previous participation in this trial. Participation is defined as randomised
- •Participation in any clinical trial within 3 months prior to this trial
- •Clinically significant abnormal haematology, biochemistry, lipids, or urinalysis screening tests, as judged by the Investigator considering the underlying disease
- •Supine blood pressure at screening outside the range of 90-160 mmHg for systolic or 50-95 mmHg for diastolic and/or resting supine heart rate outside the range 50 -90 beats per minute. This exclusion criterion also pertains to subjects being on antihypertensives
- •Use of GLP-1 receptor agonists or oral antidiabetic drugs (OADs) other than stable intake of metformin within 4 weeks prior to screening
- •Women of child bearing potential, not willing to use contraceptive methods
研究组 & 干预措施
Biochaperone Combo
single subcutaneous injection of 0.8 U/kg + injection of placebo (0.9% NaCl) to ensure the double dummy
干预措施: Biochaperone Combo (Drug)
Biochaperone Combo
single subcutaneous injection of 0.8 U/kg + injection of placebo (0.9% NaCl) to ensure the double dummy
干预措施: Placebo (Drug)
Humalog Mix25
single subcutaneous dose of 0.8 U/kg + injection of placebo (0.9% NaCl) to ensure the double dummy
干预措施: Humalog Mix25 (Drug)
Humalog Mix25
single subcutaneous dose of 0.8 U/kg + injection of placebo (0.9% NaCl) to ensure the double dummy
干预措施: Placebo (Drug)
Humalog and Lantus
simultaneous subcutaneous injections of 0.2 U/kg Humalog and 0.6 U/kg Lantus
干预措施: Humalog (Drug)
Humalog and Lantus
simultaneous subcutaneous injections of 0.2 U/kg Humalog and 0.6 U/kg Lantus
干预措施: Lantus (Drug)
结局指标
主要结局
Area under the glucose infusion rate curve (AUCGIR) 12-30h (mg/kg)
时间窗: from 12h to 30 hours
Area under the glucose infusion rate curve from 12 hours to 30 hours
次要结局
- tmax Gla(Up to 30 hours)
- tmax Lis(Up to 30 hours)
- AUCLis 0-30h(Up to 30 hours)
- AUCGIR 0-last (mg/kg)(Up to 30 hours)
- AUCGla 0-30h(Up to 30 hours)
- Hypoglycaemic episodes(Up to 9 weeks)
- tGIRmax(Up to 30 hours)
- GIRmax (mg/kg/min)(Up to 30 hours)
- Local tolerability(Up to 9 weeks)
- Adverse events(Up to 9 weeks)