NCT04660305已完成1 期
Phase 1 Single Dose, Randomised, Double-blind, Two-way Crossover, Glucose Clamp Study Investigating the Pharmacodynamics, Pharmacokinetics and Safety of Arecor Rapid-acting Concentrated Insulin Aspart (AT278) in Comparison to Insulin Aspart NovoRapid® in Participants With Type 1 Diabetes Mellitus (T1DM).
Arecor Limited1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2020年12月2日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Area under the glucose infusion-rate curve of insulin aspart
研究概览
简要总结
A phase 1, randomised, single-centre, double-blind, single-dose, two period balanced cross over study in a glucose clamp setting. The study compares the pharmacodynamic, pharmacokinetic and safety characteristics of AT278 and NovoRapid® in male participants with type 1 diabetes.
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
- Male
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of type 1 diabetes for at least 12 months
- •Receiving treatment with multiple daily insulin injections or insulin pump therapy for at least 12 months
- •HbA1c concentration ≤8.5% at screening
- •Weight within the range 75kg - 100kg (both inclusive)
排除标准
- •Known or suspected hypersensitivity to Investigational Medicinal Products
- •Clinically significant concomitant disease or abnormal lab values
- •Supine systolic BP outside range 95-140mmHg and/or diastolic BP greater than 90mmHG
研究组 & 干预措施
AT278
Experimental
Single subcutaneous injection 0.3U/kg
干预措施: AT278 (Drug)
AT278
Experimental
Single subcutaneous injection 0.3U/kg
干预措施: NovoRapid (Drug)
NovoRapid
Active Comparator
Single subcutaneous injection 0.3U/kg
干预措施: AT278 (Drug)
NovoRapid
Active Comparator
Single subcutaneous injection 0.3U/kg
干预措施: NovoRapid (Drug)
结局指标
主要结局
Area under the glucose infusion-rate curve of insulin aspart
时间窗: 0 - 8 hours
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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