Pharmacodynamic and Pharmacokinetic Properties of Insulin Aspart: Dose - Ranging vs. Human Soluble Insulin
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- AUC GIR 360-720 min
研究概览
简要总结
The metabolic effect of three different doses of insulin aspart and human insulin are investigated with the euglycaemic glucose clamp technique.
详细描述
Double-blind, randomized, 6-period cross-over study in 16 healthy subjects. Each patient participates in 6 euglycemic glucose clamp experiments each.
The time interval between the study days is 2 to 28 days. At the clamp visits, subjects are connected to a Biostator (MTB Medizintechnik, Ulm, Germany) and receive an intravenous human insulin infusion (rate of 0.15 mU/kg/min) over the duration of each experiment to prevent a rise in endogenous insulin secretion. After a baseline period of 2 h the trial drug (6, 12, or 24 U of either Insulin Aspart or regular human insulin in random order) are administered s.c. with a syringe into the abdominal wall. Glucose infusion rates (GIR) necessary to keep blood glucose concentrations close to the clamp level of 90 mg/dl (5 mmol/l) are administered and recorded by the Biostator every minute for a period of 12 h post-dosing. Blood samples are drawn at regular intervals for the analysis of C-peptide and (depending on the trial drug administered) serum insulin or serum Insulin Aspart concentrations (measured with specific ELISAs).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Participation in any other clinical trial and receipt of any investigational drug within four weeks prior to this trial
- •Previous participation in this trial
- •Clinically significant abnormal haematology or biochemistry screening test
- •Any disease requiring use of non topical prescription medicines
- •Any serious systemic infectious disease that occurred in the four weeks prior to the first dose of test drug
- •Any intercurrent illness that may affect blood glucose
- •Current addiction to alcohol or substances of abuse as determined by the investigator
- •Known or suspected allergy against insulin or any component of the composition of the trial drug
- •Blood donation > 500 ml within the last nine weeks
- •Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation
- •If female, subject is pregnant or lactating
研究组 & 干预措施
1
6 U insulin aspart
干预措施: insulin aspart (Drug)
2
12 U insulin aspart
干预措施: insulin aspart (Drug)
3
24 U insulin aspart
干预措施: insulin aspart (Drug)
4
6 IU human regular insulin
干预措施: human regular insulin (Drug)
5
12 IU human regular insulin
干预措施: human regular insulin (Drug)
6
24 IU human regular insulin
干预措施: human regular insulin (Drug)
结局指标
主要结局
AUC GIR 360-720 min
时间窗: at each dosing (6 times during the trial)
次要结局
- PD endpoints like GIR max, t max/GIR, AUC GIR 0-120 min, AUC GIR 0-720 min, t >2/GIR, early and late t 50%/GIR(at each dosing visit (6 times during the study))
- PK endpoints such as C max/ins, t max/ins, AUC ins 0-120 min, AUC ins 360-720 min, AUC ins 0-720 min(at each dosing visit (6 times during the study))