NCT01464099已完成1 期
A Single Center, Randomized, Double-blind, Balanced Two-period Cross-over Trial to Test for Bioequivalence Between a Marketed NovoLog® Formulation Containing 100 U/mL Versus a New NovoLog® Formulation Containing 200 U/mL in a Combined Regimen of a Continuous Subcutaneous Infusion and a Meal-time Bolus in Subjects With Type 1 Diabetes
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Area under the insulin aspart bolus concentration-time curve
研究概览
简要总结
This trial is conducted in the United States of America (USA). The aim of this trial is to evaluate the clinical performance of two formulations of insulin aspart (NovoLog®) in subjects 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
- 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
- 否
入选标准
- •Subjects with type 1 diabetes treated with insulin for at least 12 months
- •BMI (Body Mass Index) between 18.0-29.0 kg/m^2
- •Negative fasting C-peptide (below or equal to 0.6 ng/mL)
- •HbA1c (glycosylated haemoglobin A1c) below or equal to 10.0%
- •Current treatment with insulin below or equal to 1.2 U/kg/day
- •Subject should be in good health based on medical history, physical examination and routine laboratory data
排除标准
- •Any known/suspected allergies to trial medication or similar products/devices
- •A subject who has proliferative retinopathy or maculopathy, and/or severe neuropathy, in particular autonomic neuropathy, as judged by the Investigator
- •Clinically significant active disease of any kind
- •Recurrent major hypoglycemia or hypoglycemic unawareness, as judged by the Investigator
- •Blood donation (more than 500 mL) within the previous 9 weeks
研究组 & 干预措施
Insulin aspart 100U/mL
Active Comparator
干预措施: insulin aspart (Drug)
Insulin aspart 200U/mL
Experimental
干预措施: insulin aspart (Drug)
结局指标
主要结局
Area under the insulin aspart bolus concentration-time curve
时间窗: From 0 and up to 12 hours post bolus dose administration
Maximum plasma concentration (Cmax) of insulin aspart
时间窗: From 0 and up to 12 hours post bolus dose administration
次要结局
- Time to maximum concentration (Tmax) of insulin aspart(From 0-12 hours post bolus dose administration)
- AUC (area under the curve) of insulin aspart(From -4 to 0 hours after dose administration)
研究者
研究点 (1)
Loading locations...
相似试验
终止
2 期
Efficacy and Safety of Activated Recombinant Human Factor VII in Treatment of Bleeding in Patients Following Hematopoietic Stem Cell TransplantationAcquired Bleeding DisorderBleeding During/Following SurgeryNCT01564563Novo Nordisk A/S11
已完成
1 期
First Human Dose Trial Investigating Safety, Tolerability and Pharmacokinetics of NNC0194-0499 in Male Subjects With Overweight or ObesityMetabolism and Nutrition DisorderObesityNCT03015207Novo Nordisk A/S56
已完成
2 期
A Study of Once-Daily NNC0090-2746 in Participants With Type 2 Diabetes Inadequately Controlled With MetforminDiabetes Mellitus Type 2DiabetesNCT02205528Novo Nordisk A/S108
已完成
2 期
Safety and Preliminary Efficacy of Activated Recombinant Human Factor VII for Preventing Early Hematoma Growth in Acute Intracerebral HaemorrhageAcquired Bleeding DisorderIntracerebral HaemorrhageNCT01563445Novo Nordisk A/S40
终止
1 期
First Human Dose Study of Anti-IL-20 in Psoriasis: A Study of Safety, Tolerability and Early Signals of Biologic and Clinical EffectsInflammationPsoriasisNCT01261767Novo Nordisk A/S55