Type I Diabetes MedDRA version: 7.0 Level: PT Classification code 10012608
Conditions
Sponsors
Novo Nordisk AS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Informed consent obtained from the subject (and the subject’s parents or legally accepted representatives) before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.) 2. Type 1 diabetes for at least 12 months 3. Boys and girls between 6 and 17 years (both inclusive) 4. Body mass index (BMI) for children (6 to 12 years): 15-24 kg/m2 (both inclusive), for adolescents (13 to 17 years): 18-29 kg/m2 (both inclusive) 5. HbA1c =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Any significant disease such as endocrine disease other than thyroiditis (treated or no treatment necessary), hepatic, renal, cardiac, neurological, malignant, or pancreatic disease other than diabetes 2. Receipt of any investigational product within the last four weeks 3. Biochemical signs of hepatic diseases as indicated by values for alanine aminotransferase (ALAT) above two times the upper reference limit (according to the central laboratory) 4. Biochemical signs of renal diseases as indicated by values for creatinine outside normal ranges for the respective age group (according to the central laboratory) 5. Regular use of any systemic prescription medicines other than insulin, inhaled corticosteroids or oral contraceptive 6. Persistent micro-albuminuria or background or proliferative retinopathy as judged by the Investigator 7. Known or suspected allergy to trial products or related products 8. A life-style incompatible with the trial, as judged by the Investigator, e.g. highly variable eating habits 9. Pregnancy, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures (oral contraceptive, IUD or implants) 10. Any disease, condition, mental disorder, unwillingness or language barrier that may interfere with the trial, as determined at the discretion of the Investigator 11. Previous randomisation in this trial 12. Blood donation of more than 500 mL within the last 12 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To compare the within-subject variability of the pharmacokinetic profiles of insulin detemir and insulin glargine in children and adolescents (6 to 17 years) with type 1 diabetes;Secondary Objective: • To compare the within-subject variability of the pharmacokinetic profiles of insulin detemir and insulin glargine in children (6 to 12 years) with type 1 diabetes • To compare the within-subject variability of the pharmacokinetic profiles of insulin detemir and insulin glargine in adolescents (13 to 17 years) with type 1 diabetes • To investigate the pharmacokinetic properties of insulin detemir and insulin glargine in children (6 to 12 years) with type 1 diabetes • To investigate the pharmacokinetic properties of insulin detemir and insulin glargine in adolescents (13 to 17 years) with type 1 diabetes • To evaluate the safety profiles as assessed by standard laboratory parameters and incidence of adverse events after s.c. administration of insulin detemir and insulin glargine in children and adolescents (6 to 17 years) ;Primary end point(s): • AUC0-16h, area under the insulin concentration curve from 0 to 16 hours The primary endpoint has been chosen in order to compare the within-subject variability of the mean exposure from 0 to 16 hours of insulin detemir and insulin glargine. The within-subject variability of this endpoint is believed to reflect the risk of hyperglycaemia. | — |
Countries
Germany
Outcome results
None listed