NCT01043510已完成1 期
A Trial Investigating the Pharmacodynamic and Pharmacokinetic Properties of NN1250 at Steady State Conditions in Subjects With Type 2 Diabetes of Different Race and/or Ethnicity
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
- 63
- 试验地点
- 1
- 主要终点
- Area under the glucose infusion rate curve during one dosing interval at steady state
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 investigate the pharmacodynamic (effect) and pharmacokinetic (exposure of drug) properties of NN1250 (insulin degludec, IDeg) in subjects with type 2 diabetes of different race and/or 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Either - Black or African American not of Hispanic or Latino origin or - White of Hispanic or Latino origin or - White not of Hispanic or Latino origin
- •Type 2 diabetes mellitus (as diagnosed clinically) for at least 12 months
- •Treated with insulin for at least 3 months, alone or in combination with maximum 2 oral antidiabetic drugs (OADs)
- •Body mass index maximum 40.0 kg/m^2
排除标准
- •Use of GLP-1 receptor agonists (exenatide, liraglutide), thiazolidinediones or dipeptidyl peptidase-4 (DPP-4) inhibitors within 3 months prior to screening
- •History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction
- •Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
研究组 & 干预措施
A1, first period
Experimental
干预措施: insulin degludec (Drug)
A2, second period
Active Comparator
干预措施: insulin detemir (Drug)
B1, first period
Active Comparator
干预措施: insulin detemir (Drug)
B2, second period
Experimental
干预措施: insulin degludec (Drug)
结局指标
主要结局
Area under the glucose infusion rate curve during one dosing interval at steady state
时间窗: 0-24 hours (derived on treatment day 6)
次要结局
- Area under the Insulin Degludec concentration-time curve during one dosing interval at steady state(0-24 hours (derived on treatment day 6))
研究者
研究点 (1)
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