NCT01865279已完成1 期
A Randomised, Double-blind, Placebo-controlled Single Dose, Dose Escalation Trial With Insulin 454 in Healthy Male Subjects, Followed by a Two-period Cross-over Trial With Insulin 454 and Insulatard® in Male Subjects With Type 1 and Type 2 Diabetes Mellitus
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
- 64
- 主要终点
- Frequency of adverse events (trial part 1 only)
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to investigate the safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of insulin degludec (insulin 454), an explorative formulation, not similar to the proposed commerical formulation.
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
- Male
- 接受健康志愿者
- 是
入选标准
- •HEALTHY SUBJECTS:
- •Subjects will be healthy male subjects, who are considered to be generally healthy based on an assessment of medical history, physical examination and clinical laboratory data, as judged by the Investigator
- •Body mass index (BMI) between 18.0-27.0 kg/m^2 (both inclusive)
- •SUBJECTS WITH TYPE 1 AND TYPE 2 DIABETES:
- •Subjects will be male volunteers, who are considered to be generally healthy, except for the underlying diabetes mellitus, based on an assessment of medical history, physical examination and clinical laboratory data, as judged by the Investigator
- •Diagnosed with type 1 diabetes mellitus and treated with insulin for at least 12 months or diagnosed with type 2 diabetes mellitus for at least 12 months
- •Body Mass Index (BMI) between 18.0-27.0 kg/m^2 (both inclusive) for subjects with type 1 diabetes or 25.0-35.0 kg/m^2 (both inclusive) for subjects with type 2 diabetes
- •Glycogylated haemoglobin (HbA1c) maximum 8.5 % based on central laboratory results
- •Subjects with type 2 diabetes must have been treated with insulin for the past 3 months prior to screening
排除标准
- •Participation in any other trials involving investigational products within 3 months preceding the start of dosing
- •History of significant multiple drug allergies or with a known allergy to the trial product or any medicine chemically related to the trial product, as judged by the investigator
- •Hepatitis or carrier of the Hepatitis B surface antigen (HBsAg) or Hepatitis C antibodies or a positive result to the test for human immunodeficiency (HIV) antibodies
- •Any clinically significant abnormal haematology or biochemistry screening tests, as judged by the investigator
- •Subjects who have donated any blood or plasma in the past month or in excess of 1000 ml within the 12 weeks preceding screening
研究组 & 干预措施
Trial part 1
Experimental
干预措施: insulin degludec (Drug)
Trial part 1
Experimental
干预措施: placebo (Drug)
Trial part 2
Active Comparator
干预措施: insulin degludec (Drug)
Trial part 2
Active Comparator
干预措施: isophane human insulin (Drug)
结局指标
主要结局
Frequency of adverse events (trial part 1 only)
时间窗: From day prior to dosing and until 10-14 days after dosing
Area under the glucose infusion rate curve (trial part 2 only)
时间窗: 0-24 hours after dosing
次要结局
- Area under the serum insulin concentration curve(0-72 hours after dosing)
研究者
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