Efficacy and Safety of Faster-acting Insulin Aspart Compared to NovoRapid® Both in Combination With Insulin Degludec in Children and Adolescents With Type 1 Diabetes
Efficacy and Safety of Faster-acting Insulin Aspart Compared to NovoRapid® Both in Combination With Insulin Degludec in Children and Adolescents With Type 1 Diabetes
This trial is conducted globally. The aim of the trial is to investigate efficacy and safety of faster-acting insulin aspart compared to NovoRapid® both in combination with insulin degludec in children and adolescents with type 1 diabetes.
Inclusion Criteria: - Male or female, 1 year above or equal to age below 18 years at the time of signing informed consent and below 18 years at the time of randomisation - Diagnosed with type 1 diabetes mellitus (based on clinical judgement and supported by laboratory analysis as per local guidelines) - Ongoing daily treatment with a basal-bolus insulin regimen using basal insulin analogue or Neutral Protamine Hagedorn (NPH) insulin for at least 90 days prior to the screening visit - HbA1c (glycosylated haemoglobin) below or equal 9.5% (80 mmol/mol) analysed by the central laboratory at the screening visit Exclusion Criteria: - More than one episode of diabetic ketoacidosis requiring hospitalisation within the last 90 days prior to the screening visit - Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before screening
Ostrava - Poruba, 70852, Czechia
OYS, 90029, Finland
Saint Ingbert-Oberwürzbach, 66386, Germany
Hyderabad, Andhra Pradesh 500003, India
Hyderabad, Andhra Pradesh 500072, India
Hiroshima-shi, Hiroshima, 734-8530, Japan
Kitakyushu,Fukuoka, 8078556, Japan
Kobe-shi, Hyogo, 650-0047, Japan
Kobe-shi, Hyogo, 657-0846, Japan
Kochi-shi, Kochi, 780 0952, Japan
Kofu, Yamanashi, 400-0027, Japan
Kumamoto-shi, Kumamoto, 860 8556, Japan
Niigata-shi, Niigata, 950 1197, Japan
Niigata-shi, Niigata, 951 8520, Japan
Okayama-shi, Okayama, 700-0013, Japan
Okayama-shi, Okayama, 701-1192, Japan
Osaka-shi, Osaka, 545 8586, Japan
Ota-shi, Gunma, 373-8585, Japan
Otsu-shi, Shiga, 520-0804, Japan
Saga-shi, Saga, 840-0801, Japan
Sendai-shi, Miyagi, 980 8574, Japan
Tsu-shi, Mie, 514 0125, Japan
Yokohama-shi, Kanagawa, 232-0024, Japan