NCT01620424已完成1 期
A Randomised, Double-blind, Single-centre, Two-Period Crossover Trial Investigating the Pharmacokinetics and Pharmacodynamics of NN-X14Mix30 and NN-X14Mix50 in Type 2 Diabetic Patients
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- The maximum insulin aspart concentration
研究概览
简要总结
This trial is conducted in Japan. The aim of this trial is to investigate the pharmacokinetics and pharmacodynamics of biphasic insulin aspart 30 (NN-X14Mix30) and biphasic insulin aspart 50 (NN-X14Mix5050) in subjects 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 (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, 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 1 year
- •Body Mass Index (BMI) maximum 30.0 kg/m^2
- •HbA1c maximum 10.0%
排除标准
- •Recurrent severe hypoglycaemia
- •Proliferative or preproliferative retinopathy diagnosed within the last 12 weeks or laser therapy for retinopathy within the last 12 weeks
- •Impaired hepatic function
- •Impaired renal function
- •Cardiac problems
- •Uncontrolled treated / untreated hypertension
- •Hepatitis B surface antigen, Hepatitis C antibodies or HIV (human immunodeficiency virus) antibodies positive
- •Total daily insulin dose exceeding 40 IU
- •Treatment with OHAs (oral hypoglycaemic agents) or insulin preparations twice or more frequently a day
- •Treatment with OHAs or insulin preparations once a day later than noon
- •Subjects who smoke more than 15 cigarettes per day
研究组 & 干预措施
Dosing visit 1
Experimental
干预措施: biphasic insulin aspart 50 (Drug)
Dosing visit 1
Experimental
干预措施: biphasic insulin aspart 30 (Drug)
Dosing visit 2
Experimental
干预措施: biphasic insulin aspart 30 (Drug)
Dosing visit 2
Experimental
干预措施: biphasic insulin aspart 50 (Drug)
结局指标
主要结局
The maximum insulin aspart concentration
次要结局
- The area under the insulin aspart curve
- tmax, the time to maximum insulin aspart concentration
- t½, terminal half-life
- The area under the glucose infusion rate (GIR) profile
- GIRmax, maximum glucose infusion rate value
- tmaxGIR, time to maximum glucose infusion rate value
- The area under the glucose infusion rate profile
- Vital signs (blood pressure and pulse)
- Adverse events
研究者
研究点 (1)
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