This trial is conducted in Africa, Asia, Europe and the United States of America (USA). The aim of this trial is to investigate the efficacy and safety of insulin degludec in children and adolescents with type 1 diabetes mellitus.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
350
Injected subcutaneously (under the skin) once daily. Dose individually adjusted.
Injected subcutaneously (under the skin) once or twice daily. Dose individually adjusted.
Injected subcutaneously (under the skin) as mealtime bolus insulin. Dose individually adjusted.
Change From Baseline in HbA1c (Glycosylated Haemoglobin) (%) at 26 Weeks (Analysed by Central Laboratory)
Change from baseline in HbA1c (%) after 26 weeks of treatment.
Time frame: Week 0, week 26
Change From Baseline in HbA1c (%) at 52 Weeks (Analysed by Central Laboratory)
Change from baseline in HbA1c (%) after 52 weeks of treatments.
Time frame: Week 0, week 52
Change From Baseline in Fasting Blood Glucose (FPG) at 26 Weeks (Analysed by Central Laboratory)
Change from baseline in FPG after 26 weeks of treatment.
Time frame: Week 0, week 26
Change From Baseline in Fasting Blood Glucose (FPG) at 52 Weeks (Analysed by Central Laboratory)
Change from baseline in FPG after 52 weeks of treatment.
Time frame: Week 0, week 52
Number of Treatment Emergent Adverse Events (TEAEs)
TEAE is defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment.
Time frame: After 26 weeks and 52 weeks of treatment
Number of Hypoglycaemic Episodes
Number of hypoglycaemic episodes (severe episodes or episodes with plasma glucose (PG) below or equal to 3.9 mmol/L (70 mg/dL) with or without symptoms of hypoglycaemia) during the trial; nocturnal \[11 p.m. - 7 a.m./23:00 - 07:00\] and over the entire day (24 hours)
Time frame: After 26 weeks and 52 weeks of treatment
Number of Self-measured Hyperglycaemia (Episodes of PG Above 11.1 mmol/L (200 mg/dL))
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Novo Nordisk Investigational Site
Little Rock, Arkansas, United States
Novo Nordisk Investigational Site
Orange, California, United States
Novo Nordisk Investigational Site
San Diego, California, United States
Novo Nordisk Investigational Site
Aurora, Colorado, United States
Novo Nordisk Investigational Site
New Haven, Connecticut, United States
Novo Nordisk Investigational Site
Gainesville, Florida, United States
Novo Nordisk Investigational Site
Jacksonville, Florida, United States
Novo Nordisk Investigational Site
Maitland, Florida, United States
Novo Nordisk Investigational Site
Melbourne, Florida, United States
Novo Nordisk Investigational Site
Tallahassee, Florida, United States
...and 71 more locations
Episodes of PG \>11.1mmol/L (200mg/dL)
Time frame: After 26 weeks and 52 weeks of treatment
Number of Episodes With Self Monitored Blood Ketones Above 1.5 mmol (Capillary Blood Ketone Measurement to be Performed if Self-measured Plasma Glucose (SMPG) Exceeds 14.0 mmol/l (250 mg/dL))
Blood ketones \> 1.5mmol/L (Capillary blood ketone measurement to be performed if SMPG exceeds 14.0mmol/L (250mg/dL) )after 26 and 52 weeks of treatment
Time frame: After 26 weeks and 52 weeks of treatment
Steady-state Plasma Concentrations of Insulin Degludec and Insulin Detemir on Three Different Visits (Three Different Weeks) During the First 26 Weeks of Treatment
Steady state plasma concentrations of insulin degludec and insulin detemir on three different visits (three different weeks) during the trial.
Time frame: Between week 1 and week 26
Insulin Antibodies (Insulin Degludec Specific, Insulin Detemir Specific, Insulin Aspart Specific and Antibodies Cross-reacting to Human Insulin)
Antibody measurements : the values presented are week 52 (LOCF). The measurement of insulin antibodies after 26 and 52 weeks of treatment was done to fulfil the requirement of monitoring the long term immunogenicity. The unit of measure is percentage bound/total (%B/T) for these antibodies. The Antibodies cross reacting to Human Insulin is abbreviated as X-reacting AB Hu Insulin below)
Time frame: After 52 weeks of treatment