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
- Conditions
- Investigating the glycaemic effect and profile in children with Type 1 diabetesMedDRA version: 9.1Level: LLTClassification code 10045228Term: Type I diabetes mellitus
- Registration Number
- EUCTR2006-006715-77-FR
- Lead Sponsor
- ovo Nordisk Pharmaceutique S.A.S.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 30
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,
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method