A trial investigating the efficacy and safety of insulin degludec/insulin aspart once daily plus insulin aspart for the remaining meals versus insulin detemir once or twice daily plus meal time insulin aspart in children and adolescents with type 1 diabetes mellitus

ovo Nordisk A/S0 个研究点目标入组 346 人开始时间: 2013年9月16日最近更新: 2015年8月17日

适应症

试验速览

暂无简介。

•1) Informed consent obtained before any trial related activities. Trial related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
•2) Subjects diagnosed with type 1 diabetes mellitus
•3) Age: 1 to <18 years of age at randomisation
•4) HbA1c = 11.0%
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 346
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1) Known hypoglycaemic unawareness or recurrent severe hypoglycaemic events as judged by the investigator
•2) More than 1 episode of diabetic ketoacidosis requiring hospitalisation within the last 3 months prior to Visit 1 (Screening)
•3) Any chronic disorder or significant concomitant disease, which in the investigator’s opinion might jeopardise the subject’s safety or compliance with the protocol

发起方