Research Study Summary
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
To confirm the effect of treatment with meal-time faster-acting insulin aspart in terms of glycaemic control by comparing it to meal-time NovoRapid®, both in combination with insulin degludec using a non-inferiority approach in children and adolescents with type 1 diabetes.
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CW ID: 216183
Date Last Changed:
February 15, 2017
Clinical Trial Snapshot
- Both Male and Female
- 1 to 18 Years
- Overall Status
- Facility Type
- Diagnosed with type 1 diabetes mellitus
- Ongoing daily treatment with a basal-bolus insulin regimen using basal insulin analogue or NPH insulin for at least 90 days prior to the screening visit
- HbA1c ≤ 9.5% (80 mmol/mol)
- 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
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