临床试验/NCT01865318

NCT01865318已完成1 期

A Single Centre, Open-Label, Multiple Dose Trial Examining the Pharmacodynamic Characteristics of Insulin 454 Under Single-Dose and Steady-State Conditions in Male Subjects With Type 1 Diabetes

Novo Nordisk A/S0 个研究点目标入组 36 人开始时间: 2006年9月最近更新: 2015年10月22日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Novo Nordisk A/S
入组人数: 36
主要终点: Area under the glucose infusion rate curve

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

This trial is conducted in Europe. The aim of this trial is to investigate the pharmacodynamic (the effect of the investigated drug on the body) of insulin degludec (insulin 454), an explorative formulation, not similar to the proposed commercial formulation, under single-dose and steady-state conditions in male subjects with type 1 diabetes.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Single Group
主要目的: Treatment
盲法: None

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

•Male and 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
•Body Mass Index (BMI) between 18.0 and 27.0 kg/m^2 (both inclusive)
•Glycosylated haemoglobin A1c (HbA1c) below or equal to 10.0 % based on central laboratory results

排除标准

•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
•Participation in any other trials involving investigational products within 3 months preceding the start of dosing

研究组 & 干预措施

Part 1 (Once-daily dosing regimen, high concentration)

Experimental

干预措施: insulin degludec (Drug)

Part 2 (Twice-daily dosing regimen, high concentration)

Experimental

干预措施: insulin degludec (Drug)

Part 3 (Once-daily dosing regimen, low concentration)

Experimental

干预措施: insulin degludec (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

Time to maximum glucose infusion rate (tGIRmax)(0-24 hours after dosing)
Maximum glucose infusion rate (GIRmax)(0-24 hours after dosing)
Area under the serum insulin degludec curve(0-96 hours after dosing)

研究者

发起方

Novo Nordisk A/S

申办方类型

Industry

责任方

Sponsor

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