Comparison of Pharmacodynamics and Pharmacokinetics of the Two Fast-acting Insulin Analogs Insulin Glulisine and Insulin Aspart in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- fractional and total glucose infusion rates
研究概览
简要总结
The purpose of this study was to compare the pharmacodynamics (course of the blood glucose-lowering effect and duration of effect) and pharmacokinetics (course of the concentration of study medication in the blood) of a single subcutaneous dose of 0.2 units/kg of insulin glulisine and insulin aspart in a direct head-to-head comparison during two euglycemic glucose clamps in healthy subjects.
详细描述
In a previous glucose clamp study with a head-to-head comparison of insulin glulisine and insulin lispro it was shown that the onset of metabolic action was significantly shorter with insulin glulisine than with insulin lispro (while the total metabolic effect was not different). These results were in line with a faster early insulin exposure of insulin glulisine compared to insulin lispro. The primary aim of this study was to investigate whether or not these favorable characteristics of insulin glulisine were also evident in the comparison against insulin aspart. This was the first clinical study realizing a head-to-head comparison between these two insulin analogs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Overtly healthy males or females (Women: contraception, Pearl Index <1%)
- •Between the ages of 18 and 65 years
- •Body Mass Index of <= 27 kg/m²
- •Safety lab within reference range
- •Normal blood pressure and heart rate
- •Sufficient venous access
- •Written informed consent approved by the Ethical Review Board
- •HbA1c and fasting plasma glucose in the normal range
排除标准
- •Investigative site personnel directly affiliated with this study and their immediate families or the sponsor´s employees
- •Within 30 days of the initial dose of study drug had received treatment with a drug that had not received regulatory approval
- •Known allergies to insulin or related compounds
- •Regular treatment with any drug, both over-the-counter or prescribed
- •an abnormality in the 12-lead ECG increasing the risk for participation
- •History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
- •Significant active neuropsychiatric disease
- •Regular use of drugs of abuse and or positive findings on urinary drug screening
- •Evidence of HIV and/or positive antibodies 1 or 2 and or HIV1 antigen
- •Evidence of hepatitis B and/or positive hepatitis C antibody
- •Evidence of hepatitis B and/or positive hepatitis B surface antigen
- •Women with a positive pregnancy test or breastfeeding women
- •Blood donation more than 500 mL within the last 3 months
研究组 & 干预措施
insulin glulisine, insulin aspart
insulin glulisine administration during first glucose clamp, insulin aspart administration during second glucose clamp
干预措施: insulin glulisine, insulin aspart (Drug)
insulin aspart, insulin glulisine
insulin aspart administration during first euglycemic clamp, insulin glulisine administration during second clamp
干预措施: insulin aspart, insulin glulisine (Drug)
结局指标
主要结局
fractional and total glucose infusion rates
时间窗: 0-1 hours, 0-2 hours, and time to 10% of GIRmax
次要结局
- fractional and total insulin areas under the curve (AUC)(0-1 hours, 0-2 hours, 0-10 hours)