NCT01865292已完成1 期
A Randomised, Double-Blind, Single Dose, Six-Period Cross-over Dose Response Trial Comparing the Pharmacodynamics and Pharmacokinetics of Insulin 454 With Insulin Glargine in Subjects With Type 1 and 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
- 40
- 主要终点
- Area under the glucose infusion rate curve
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to compare the pharmacodynamics (the effect of the investigated drug on the body) and pharmacokinetics (the exposure of the trial drug in the body) of insulin degludec (insulin 454), an explorative formulation, not similar to the proposed commercial formulation, with insulin glargine in subjects with type 1 and 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
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Glycosylated haemoglobin (HbA1c) below or equal to 10 procent based on central laboratory results
- •Specific inclusion criteria for subject with type 1 diabetes:
- •Diagnosed with type 1 diabetes mellitus and treated with insulin for at least 12 months prior to screening
- •Body Mass Index (BMI) between 18.0 and 27.0 kg/m^2 (both inclusive)
- •Specific inclusion criteria for subject with type 2 diabetes:
- •Diagnosed with type 2 diabetes mellitus for at least 12 months prior to screening
- •Treated with insulin for the past 3 months prior to screening
- •Body Mass Index (BMI) between 22.0 and 35.0 kg/ m^2 (both inclusive)
排除标准
- •Subject with a history of significant multiple drug allergies or with a known allergy or suspected allergy to the trial product or any medicine chemically related to the trial product,as judged by the Investigator.
- •Subject with a history of or presence of cancer
- •Any condition that the Investigator and/or Sponsor feels would interfere with study
- •Specific exclusion criteria for subject with type 2 diabetes:
- •Therapy with oral antidiabetic drugs within the past 3 months prior to screening
研究组 & 干预措施
Insulin degludec
Experimental
干预措施: insulin degludec (Drug)
Insulin glargine
Active Comparator
干预措施: insulin glargine (Drug)
结局指标
主要结局
Area under the glucose infusion rate curve
时间窗: 0-24 hours after dosing
次要结局
- Area under the insulin degludec/insulin glargine curve(0-96 hours after dosing)
研究者
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