A Mono Center Open Labeled, Randomized Study Examining the Effects of Intra-Dermal vs Subcutaneous Application of Regular Insulin or Rapid Acting Insulin Analogue on Postprandial Glycemic Excursions in Patients With Type 1 Diabetes
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Area Under Curve (AUC) of the blood glucose (BG) profile after the meal, with and without baseline correction.
研究概览
简要总结
This study is to determine the effect of intra-dermal (ID) administration of regular and of rapid-acting insulin, before eating, on blood glucose levels for several hours after a standard meal (a mixed, liquid meal). Insulin will also be given normally, subcutaneously, for control or comparison purposes. The hypothesis or expectation is that ID insulin will work more quickly and control blood glucose levels better than SC injection.
详细描述
Previous studies have shown that intra-dermal (ID) insulin administration results in a more rapid onset of action in comparison to subcutaneous (SC) administration as measured by glucose infusion rate (GIR) under glucose clamp conditions.The aim of this study is to investigate whether ID administration of regular human insulin or rapid-acting insulin analogue leads to reduced postprandial glycemic excursions in comparison to SC application under highly standardized experimental conditions. Effects on the occurrence of hypoglycemia will also be investigated, as well as pK and pD comparisons between different insulin formulations administered ID. This is a mono-center, open-label, randomized, 5-period crossover study in patients 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
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes for 1-15 years, on multiple daily injections (MDI) or insulin pump (CSII) in stable control with HbA1c <= 9.0%.
- •Able to attend clinic for 5 different days
排除标准
- •BMI > 32 kg/m2
- •Evidence of gastroparesis or impaired renal function or lipodystrophy
研究组 & 干预措施
1
Regular insulin SC at -17 mins
干预措施: Regular insulin (Humulin) (Drug)
2
Regular insulin ID at -17 mins
干预措施: Regular insulin (Humulin) (Drug)
3
Regular insulin ID at -2 mins
干预措施: Regular insulin (Humulin) (Drug)
4
Insulin lispro given SC at -2 mins
干预措施: Insulin lispro (Humalog) (Drug)
5
Insulin lispro given ID at -2 mins
干预措施: Insulin lispro (Humalog) (Drug)
结局指标
主要结局
Area Under Curve (AUC) of the blood glucose (BG) profile after the meal, with and without baseline correction.
时间窗: 90 mins
次要结局
- Maximal BG (BGmax)(Approximately 4 hours per injection)
- Total BG-AUC0-4 h(Approximately 4 hrs per injection)
- Minimal BG (BGmin, time to BGmin (tBGmin)(Approximately 4 hrs per injection)
- Insulin pharmacokinetics(Approximately 4 hrs per injection)
- Number and seriousness of adverse events(Approximately 4 hrs per injections)
- Vital signs, examination of insulin application(Approximately 4 hrs per injection)
- Time to BGmax (tBGmax)(Approximately 4 hours per injection)