A Trial Investigating the Efficacy and Safety of Insulin Degludec in Children and Adolescents With Type 1 Diabetes Mellitus
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: insulin degludec; insulin detemir; insulin aspart
Intervention description: 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.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin Detemir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 350.0
Sex: All
Minimum age: 1 Year
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Informed consent, and child assent as age-appropriate, obtained before any
             trial-related activities (Trial-related activities are any procedure that would not
             have been performed during normal management of the subject). The parents or legal
             representative of the child must sign and date the Informed Consent Form according to
             local requirements. The child, if possible, parents or legal representative of the
             child must sign and date the Child Assent Form according to local requirements

          -  Male or female diagnosed with type 1 diabetes mellitus (T1DM) (based on clinical
             judgement and supported by laboratory analysis as per local guidelines)

          -  Ongoing daily treatment with insulin (any regimen) for at least 3 months prior to
             Visit 1 (screening). No OADs (oral anti-diabetic drugs) are allowed

          -  HbA1c (glycosylated haemoglobin) maximum 11%

        Exclusion Criteria:

          -  Known or suspected hypersensitivity to trial product(s) or related products

          -  Previous participation in this trial. Participation is defined as randomisation

          -  Girls who are pregnant, breastfeeding or intend to become pregnant

          -  Girls who have had menarche and are not using adequate contraceptive measures
             according to local requirements

          -  Known hypoglycaemic unawareness or recurrent severe hypoglycaemic events as judged by
             the Investigator (trial physician)

          -  More than 1 diabetic ketoacidosis requiring hospitalisation within the last 3 months
             prior to Visit 1

          -  Significant concomitant disease, except for conditions associated with type 1 diabetes
             mellitus, which in the Investigator's opinion could interfere with the trial

          -  The receipt of any investigational drug within 1 month prior to Visit 1