BEGIN: Young 1; A trial investigating the efficacy and safety of insulin degludec in children and adolescents with type 1 diabetes mellitus
This is a 26-week, open-Labelled, randomized, parallel, efficacy and safety comparison of insulin degludec and insulin detemir in children and adolescents 1 to less than 18 years with type 1 diabetes mellitus on a basal-bolus regimen with insulin aspart as bolus insulin. Patients will be screened and randomized to the treatment arm (long acting insulin analogue, insulin degludec) or the comparison arm (long acting insulin analogue, insulin detemir also called Levemir). Both groups will use insulin aspart as mealtime insulin. Patients will have an equal chance of being randomized to either group. Patients will then be monitored weekly through either clinic visits or phone calls with strict glucose monitoring and insulin titration per protocol. There will then be a 26 week extension period evaluating long term safety and efficacy. Patients will remain on the insulin to which they were randomized at Visit 2 plus insulin aspart at mealtimes for the extension period of the study.
The primary endpoint is change from baseline in Hba1c (%) after 26 weeks of treatment (analysed by central laboratory).
The secondary endpoints are:
* Change from baseline in fasting blood glucose (FPG) after 26 weeks of treatment (analyzed by central laboratory)
* number of treatment emergent adverse events (Teaes)
* number of hypoglycemic episodes (severe episodes or episodes with plasma glucose (PG) [LessThanorequalTo] 3.9 mmol/L (70 mg/dL) with or without symptoms of hypoglycaemia) during the trial; nocturnal [11 p.m. - 7 a.m./23:00 x 07:00] and over the entire day (24 hours) after 26 weeks of treatment
* number of self-measured hyperglycaemia (episodes of PG [Greater Than] 11.1 mmol/L (200 mg/dL)) after 26 weeks of treatment
* number of episodes with self monitored blood ketones [Greater Than]1.5 mmol (capillary blood ketone measurement to be performed if self-measured plasma glucose (SMPG) exceeds 14.0 mmol/l (250 mg/dL)) after 26 weeks of treatment
* Steady-state plasma concentrations of insulin degludec and insulin detemir on three different visits (three different weeks) during the trial
Secondary endpoints evaluating glucose control include:
* Hba1c after 52 weeks of treatment, post-prandial glucose, FPG and within-subject variability of SMPG.
1) Informed consent and child assent, as age-appropriate, obtained before any trial-related
activities (Trial-related activities are any procedure that would not have been performed
during normal management of the subject). The parents or legal representative of the child
must sign and date the Informed Consent Form (according to local requirements). The child,
if possible, parents or legal representative of the child must sign and date the Child Assent
Form (according to local requirements).
2) Male or female diagnosed with T1DM (based on clinical judgement and supported by
laboratory analysis as per local guidelines).
3) Age: 1 to less than 18 years of age at randomisation
4) Ongoing daily treatment with insulin (any regimen) for at least 3 months prior to Visit 1. No
oral anti-diabetic medications are allowed.
5) Total daily dose of insulin: <= 2.0 U/kg
6) HbA1c <= 11%
7) Ability and willingness to adhere to the protocol including performance of 4-point and 8-
point plasma glucose profiles according to the protocol (child and parent should be
evaluated as a unit).
8) Extension period: patients may only be asked to participate in the extension period who have completed the main part of the trial. No extension procedures may be performed prior to obtaining patient informed consent/assent.