Comparing the Metabolic Control of Once to Twice-daily Insulin Detemir Injections
Status:
Completed
Trial end date:
2010-03-01
Target enrollment:
Participant gender:
Summary
An open-label, treat to target, intervention study in order to compare the metabolic control
of once to twice-daily insulin Detemir injections in children and adolescence with type 1
diabetes mellitus.
All eligible patients will be assigned to receive insulin Detemir once daily before
breakfast. Short acting insulin analog, Novorapid, will be used for mealtime insulin. The
starting dose of insulin Detemir will be individually determined.Based on self-measured
fasting blood glucose levels, insulin doses will be titrated throughout the trial, aiming at
pre-breakfast and premeal concentrations of 90-180 mg/dl for subjects aged 6-12 years and
80-130 mg/dl for subjects aged 13-18 years.Patients that after 4 weeks titration phase will
not achieve the target blood glucose and up titration of insulin Detemir cannot be done, due
to hypoglycemic episodes would be switched to treatment consist of twice daily insulin
Detemir. If the target blood glucose are not achieved at the end of the 4 weeks titration
phase, but further up titration is possible and patient does not suffer from hypoglycemic
episodes, the titration period would be extended and patient would not be switched to
treatment with 2 injections of insulin Detemir.When achieving blood glucose targets patient
will continue until study end on the maintenance phase.