NCT00676819已完成4 期
Comparison of the Pharmacodynamics and Pharmacokinetics of Insulin Aspart and Human Soluble Insulin in Geriatric Subjects With Type 2 Diabetes Mellitus
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Glucose infusion rate
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to investigate if the pharmacodynamic / pharmacokinetic properties of insulin aspart and human soluble insulin are different in elderly (65 years of age or older) with type 2 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
- Double
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes
- •Duration of diabetes for at least 12 months
- •Current treatment with human insulin or insulin analogues for at least 6 months
- •BMI equal to or below 35 kg/m2
- •HbA1c equal to or greater than 10.0 %
- •No clinically significant cardiovascular event as judged by the Investigator within the last 6 months prior to the study
排除标准
- •History of any illness that, in the opinion of the Investigator might confound the results of the study or pose additional risk in administering the trial products to the subject
- •Current treatment with systemic corticosteroids
- •Any positive reaction of drug of abuse or alcohol screen
- •Cardiac problems defined as: decompensated heart failure and/or angina pectoris
- •Uncontrolled treated/untreated hypertension as judged by the Investigator or blood pressure > 180 mm Hg systolic and/or > 110 mm Hg diastolic
- •Known or suspected allergy to trial product or related products
- •Blood donation of more than 500 ml within the last 12 weeks
- •The receipt of any investigational drug within 4 weeks prior to this trial
结局指标
主要结局
Glucose infusion rate
时间窗: in the time period from 0 to 120 min after administration of trial products (AUCGIR(0-120 min))
次要结局
- GIRmax: the maximal GIR value(tmax, GIR: the time to maximal GIR value)
- AUCGIR(0-300 min) the area under the GIR profile(in the interval 0-300 minutes post dosing)
- AUCGIR(300min-end of clamp) the area under the GIR profile(in the interval 300-600 minutes post dosing (or 300 min until termination of the glucose clamp if abandoned early because of high blood glucose values))
- early and late t50%, GIR(the time to early and late half-maximal GIR value)
- AUCINS(0min-end of clamp) the area under the serum insulin (or serum insulin aspart) profile(in the interval 0-600 minutes post dosing (or 0 min until termination of the glucose clamp if abandoned early because of high blood glucose values))
- Cmax,ins: the maximal serum insulin (or serum insulin aspart) concentration
- AUCGIR(0 min-end of clamp) the area under the GIR profile(in the interval 0-600 minutes post dosing (or 0 min until termination of the glucose clamp if abandoned early because of high blood glucose values))
- AUCINS(0-60 min) the area under the serum insulin (or serum insulin aspart) profile(in the interval 0-60 minutes post dosing)
- AUCINS(300min-end of clamp) the area under the serum insulin (or serum insulin aspart) profile(in the interval 300-600 minutes post dosing (or 300 min until termination of the glucose clamp if abandoned early because of high blood glucose values))
- AUCINS(0-300 min) the area under the serum insulin (or serum insulin aspart) profile(in the interval 0-300 minutes post dosing)
研究者
研究点 (2)
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