Investigating the glycaemic effect and profile in children with Type 1 diabetes MedDRA version: 9.1 Level: LLT Classification code 10045228 Term: Type I diabetes mellitus
Conditions
Interventions
Trade Name: Levemir Penfill
Product Code: NN304
Pharmaceutical Form: Solution for injection
Concentration unit: U/ml unit(s)/millilitre
Concentration type: equal
Concentration number: 100-
Trade Name
Sponsors
Novo Nordisk Pharmaceutique S.A.S.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 (=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the trial is to assess if using insulin detemir mixed with insulin aspart in the same syringe and 2 separates injections of insulin detemir and insulin aspart will have any clinical impact in the glycaemic control assessed by HbA1c after 8 weeks of treatment.;Secondary Objective: •To compare post prandial AUC glycaemia assessed by consecutives 3 days of CGMS measurements in each treatment period •To compare blood glucose excursions measured by consecutives 3 days of CGMS measurements in each treatment period •Dose titration procedures (number of contacts with health care practionners to help for dose titration, time to target) •Glycaemic values 15 days between visit 2 (if available) and 15 days between visit 4 •Intra and inter individual variability •Fructosamine •Weight •Patients and care givers overall satisfaction measured by VAS •Insulin aspart and insulin detemir pharmacokinetics from 8h00-12h00 at the end of each period •Adverse Events •Hypoglycaemic events ;Primary end point(s): -HbA1c, end of trial -Pharmacokinetics at visit 2 and visit 4 -4-points Plasma Glucose (PG) profile at least, end of trial -Fructosamine end of trial -Self Measured Plasma Glucose (SMPG), end of trial -CGMS, end of trial -Patient Diary | — |
Countries
France
Outcome results
None listed