NCT01497600已完成1 期
A Randomised, Double-blind, Six-period, Cross-over, Dose-response Trial Investigating the Pharmacodynamics and Pharmacokinetics of Single Doses of Insulin Detemir and NPH Insulin in Subjects of Blacks or African American, Whites of Hispanic or Latino Origin and Whites Not of Hispanic or Latino Origin With Type 2 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
- 50
- 试验地点
- 1
- 主要终点
- Area under the glucose infusion rate 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 the dose-response of insulin detemir and insulin NPH in subjects with type 2 diabetes of various race and ethnicity.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes
- •Insulin treatment with any insulin preparation/regimen for at least three months with or without combination with below or equal to 2 oral antidiabetic agents (OADs)
- •Duration of diabetes at least 12 months
- •Body Mass Index (BMI) below 33 kg/m^2
- •HbA1c maximum 10 % based on analysis from the central laboratory
排除标准
- •Current treatment with insulin above 1.2 U/kg/day
- •Current treatment with drugs known to interfere with glucose metabolism other than OADs such as systemic corticosteroids, non-selective beta-blockers, and monoamino oxidase (MAO) inhibitors
- •Blood donation of more than 500 mL within the last three months
研究组 & 干预措施
insulin detemir
Experimental
干预措施: insulin detemir (Drug)
insulin detemir
Experimental
干预措施: insulin NPH (Drug)
insulin NPH
Active Comparator
干预措施: insulin detemir (Drug)
insulin NPH
Active Comparator
干预措施: insulin NPH (Drug)
结局指标
主要结局
Area under the glucose infusion rate curve
次要结局
- Maximum glucose infusion rate
- Area under the serum insulin curve
- Maximum serum insulin concentration
- Terminal rate constant of insulin
- Adverse events
- Time to maximum glucose infusion rate.
- Time to maximum insulin concentration
- Terminal half-life of insulin
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
A Trial Comparing the Safety and Efficacy of Insulin Degludec and Insulin Glargine, With or Without OADs in Subjects With Type 2 DiabetesDiabetesDiabetes Mellitus, Type 2NCT02030600Novo Nordisk A/S721
已完成
1 期
Single Dose Pharmacokinetics of Repaglinide, Metformin and Combination Tablet in Healthy VolunteersDiabetesDiabetes Mellitus, Type 2NCT01489644Novo Nordisk A/S62
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
Single Dose Pharmacokinetics of Repaglinide, Metformin and Combination Tablet in Fed Healthy VolunteersDiabetesDiabetes Mellitus, Type 2NCT01490658Novo Nordisk A/S93
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