A Trial Investigating the Efficacy and Safety of Insulin Degludec in Children and Adolescents With Type 1 Diabetes Mellitus

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