A Randomised, Double-blind, Multiple Period Crossover Trial Comparing Insulin 454 and Insulin Aspart Premixes With Separately Injected, Simultaneous Doses of Insulin 454 and Insulin Aspart, Compared With Biphasic Insulin Aspart 30 (NovoMix® 30) in Male Subjects With Type 1 and Type 2 Diabetes Mellitus
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 59
- 主要终点
- Area under the insulin aspart concentration curve from 0-2 hours (for subjects with type 1 diabetes)
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to compare different ratios of explorative formulations, not similar to the proposed commercial formulation, of IDegAsp (co-formulation of insulin degludec/insulin aspart and insulin aspart) with separately injected, simultaneous doses of insulin degludec (insulin 454), and insulin aspart, compared with biphasic insulin aspart 30 in male subjects with type 1 and type 2 diabetes mellitus.
Trial part 1 is a five-period cross-over trial with incomplete block-design in subjects with type 1 diabetes where each subject will be randomised to five out of the ten possible treatments. Each treatment consists of an injection of the insulin product followed by a euglycemic clamp with a washout period of 7-15 days between treatments.
Trial part 2 is a three-period cross-over trial with complete blockdesign in subjects with type 2 diabetes. Each treatment consists of an injection of the insulin product followed by a euglycaemic clamp with a washout period of 7-15 days between treatments.
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
- 是
入选标准
- •The subject will be a male volunteer, who is considered to be generally healthy, except for underlying diabetes mellitus and concomitant medical complications (e.g. hypertension) based on an assessment of medical history, physical examination and clinical laboratory data, as judged by the Investigator
- •Glycosylated haemoglobin A1c (HbA1c) below or equal to 10 % based on central laboratory results
- •ADDITIONAL INCLUSION CRITERA FOR SUBJECTS WITH TYPE 1 DIABETES:
- •Diagnosed with type 1 diabetes mellitus and treated with insulin for at least 12 months
- •Body Mass Index (BMI) between 18.0 and 27.0 kg/m^2 (both inclusive)
- •ADDITIONAL INCLUSION CRITERA FOR SUBJECTS WITH TYPE 2 DIABETES:
- •Diagnosed with type 2 diabetes mellitus for at least 12 months
- •Treated with insulin for the last 3 months prior to screening.
- •Body Mass Index (BMI) between 22.0 and 35.0 kg/m^2 (both inclusive)
排除标准
- •A subject with a history of significant multiple drug allergies or with a known or suspected allergy to the trial product or any medicine chemically related to the trial product, as judged by the Investigator
- •A subject who has participated in any other trials involving investigational products within the 3 months preceding the start of dosing
研究组 & 干预措施
Trial part 1
干预措施: insulin degludec/insulin aspart 30 (Drug)
Trial part 1
干预措施: insulin degludec/insulin aspart 40 (Drug)
Trial part 1
干预措施: insulin degludec/insulin aspart 50 (Drug)
Trial part 1
干预措施: insulin degludec (Drug)
Trial part 1
干预措施: insulin aspart (Drug)
Trial part 1
干预措施: biphasic insulin aspart 30 (Drug)
Trial part 2
干预措施: insulin degludec/insulin aspart 40 (Drug)
Trial part 2
干预措施: insulin degludec/insulin aspart 50 (Drug)
Trial part 2
干预措施: biphasic insulin aspart 30 (Drug)
结局指标
主要结局
Area under the insulin aspart concentration curve from 0-2 hours (for subjects with type 1 diabetes)
时间窗: 0-2 hours after dosing
Maximum glucose infusion rate divided by the average glucose infusion rate (for subjects with type 2 diabetes)
时间窗: 0-24 hours after dosing
次要结局
- Area under the glucose infusion rate curve(0-24 hours after dosing)
- Area under the serum insulin degludec concentration curve(0-96 hours after dosing)