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
Status: | Completed |
---|---|
Conditions: | Diabetes, Diabetes |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 1 - 17 |
Updated: | 4/6/2019 |
Start Date: | May 4, 2016 |
End Date: | March 3, 2018 |
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.
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
We found this trial at
36
sites
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