NCT01498926已完成1 期
A Randomised, Single Centre, Two-period, Cross-over, Glucose Clamp Trial to Test for Bioequivalence Between Two Insulin Detemir Formulations Containing Mannitol and Glycerol as Isotonic Agents Respectively, in Healthy Subjects
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
- 34
- 主要终点
- Area under the serum insulin detemir concentration curve
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to compare two formulations of insulin detemir containing an isotonic agent in healthy volunteers.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Considered generally healthy upon completion of medical history and physical examination as judged by the Investigator
- •Body mass index (BMI) between 18 and 27 kg/m^2, inclusive
- •Non-smoker
- •Fasting plasma glucose maximum 6 mmol/L
排除标准
- •Known or suspected allergy to trial products or related products
- •Previous participation in this trial
- •Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures (intrauterine device (IUD) that has been in place for at least 3 months, sterilisation, the oral contraceptive pill (which should have been taken without difficulty for at least 3 months) or an approved hormonal implant)
- •The receipt of any investigational drug within the last 3 months prior to this trial
研究组 & 干预措施
Glycerol
Experimental
干预措施: insulin detemir (Drug)
Mannitol
Active Comparator
干预措施: insulin detemir (Drug)
结局指标
主要结局
Area under the serum insulin detemir concentration curve
Maximum serum insulin concentration
次要结局
- Time to maximum serum insulin concentration
- Terminal serum insulin half life
- Area under the serum insulin detemir concentration curve
- Maximum glucose infusion rate
- Area under the glucose infusion rate curve
- Time to maximum glucose infusion rate
- Adverse events
研究者
相似试验
已完成
1 期
Comparison of Insulin Aspart Produced by Current Process and the NN2000 ProcessHealthyDiabetesNCT01486914Novo Nordisk A/S28
已完成
1 期
Comparison of IDegAsp (Inclusive Three Explorative Formulations) With Insulin Degludec and Insulin Aspart Separately Injected in Subjects With Type 1 DiabetesDiabetesDiabetes Mellitus, Type 1NCT01868568Novo Nordisk A/S55
已完成
2 期
Comparison of Two NN5401 Formulations Versus Biphasic Insulin Aspart 30, All in Combination With Metformin in Subjects With Type 2 DiabetesDiabetesDiabetes Mellitus, Type 2NCT00613951Novo Nordisk A/S182
已完成
1 期
Comparison of Two Liraglutide Formulations in Healthy VolunteersHealthyDiabetesNCT01508897Novo Nordisk A/S22
已完成
3 期
Comparison of Two Pen Systems in Patients With Diabetes Treated With InsulinDelivery SystemsDiabetesDiabetes Mellitus, Type 2Diabetes Mellitus, Type 1NCT00569998Novo Nordisk A/S208