A randomised, multicentric, open labelled, parallel group trial with insulin aspart and insulin detemir, investigating the glycaemic effect and profile in children with Type 1 diabetes, of two separate Levemir® + NovoRapid® injections and extemporaneous mixing.THE Paediatric MIXING TRIA

ovo Nordisk Pharmaceutique S.A.S.0 个研究点目标入组 30 人开始时间: 2007年4月23日最近更新: 2022年4月4日

试验速览

暂无简介。

•1.Parents Informed Consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject).
•2.Obtained child’s assent (when possible)
•3.Type1 diabetes,
•4.Subject = 6 years old,
•5.Subject treated by insulin detemir and insulin aspart either in extemporaneous mixing or separate injections twice daily with or without aspart insulin injections at lunch, break, or bed time.
•6.Subject with a good glycaemic control with HbA1c=8.6%
•7.Subject with fasting and pre-dinner target achievements (<120mg/dl)
•8.Subject is likely to comply with the Investigators instruction
•9.Fertile females (girls who have had their first menstrual period) must use adequate contraception (contraceptive pills or intrauterine device (IUD)) if there is any risk of pregnancy in the opinion of the Investigator.
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•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.History of alcoholism, drug abuse, or psychiatric disease or personality disorders likely to invalidate voluntary consent or to prevent good compliance with the trial protocol,
•2.Mental incapacity, unwillingness or language barrier precluding adequate understanding or co-operation
•3.Anticipated change or new use in concomitant medication known to interfere with glucose metabolism, such as systemic corticotherapy more than 5 mg/day (prednisone)
•4.Any other condition that the Investigator feels would interfere with trial participation or evaluation of results,

发起方

ovo Nordisk Pharmaceutique S.A.S.