临床试验/NCT01467414

NCT01467414终止1 期

A Trial Investigating the Pharmacodynamic Properties of NN1250 in Japanese Subjects With Type 2 Diabetes

Novo Nordisk A/S0 个研究点目标入组 1 人开始时间: 2011年10月最近更新: 2013年11月27日

适应症

干预措施

试验速览

阶段: 1 期
状态: 终止
发起方: Novo Nordisk A/S
入组人数: 1
主要终点: Area under the glucose infusion rate curve during one dosing interval at steady state

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 clinical trial is to investigate the pharmacodynamic (the effect of the investigated drug on the body) properties of NN1250 (insulin degludec) in Japanese subjects with type 2 diabetes.

研究设计

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

入排标准

年龄范围: 20 Years 至 70 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Male or female Japanese subject aged 20-70 years (both inclusive)
•Japanese passport holder
•Japanese-born parents
•Type 2 diabetes mellitus (as diagnosed clinically) for at least 12 months
•Treated with insulin for at least 3 months
•Body Mass Index (BMI) maximum 33.0 kg/m^2
•Glycosylated haemoglobin A1c (HbA1c) maximum 10.0%
•Fasting C-peptide below 1.0 nmol/L

排除标准

•Use of oral antidiabetic drugs (OADs) and/or glucagon like peptide-1 (GLP-1) receptor agonists (exenatide, liraglutide) within 3 months prior to screening
•Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
•Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period
•Supine blood pressure at screening (after resting for 5 min) minimum 180 mmHg for systolic and/or minimum 100 mmHg for diastolic

研究组 & 干预措施

NN1250

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: Within 0-24 hours after last dosing

次要结局

Area under the serum insulin degludec concentration-time curve during one dosing interval at steady state(Within 0-24 hours after last dosing)
Maximum glucose infusion rate at steady state(Within 0-24 hours after last dosing)
Maximum observed serum insulin degludec concentration at steady state(Within 0-24 hours after last 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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