Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novo Nordisk A/S
Age
1–17
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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%
You may not be if
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
Clareo Health | A Trial Investigating the Efficacy and Safety of Insulin Degludec in Children and Adolescents With Type 1 Diabetes Mellitus
