A trial investigating the efficacy and safety of insulin degludec in children and adolescents with type 1diabetes mellitus
- Conditions
- Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]Diabetes Mellitus, Type 1MedDRA version: 14.1Level: LLTClassification code 10045228Term: Type I diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders
- Registration Number
- EUCTR2011-003148-39-FI
- Lead Sponsor
- ovo Nordisk A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 346
1) 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.
2) Male or female diagnosed with type 1 diabetes mellitus (T1DM) (based on clinical judgement and supported by laboratory analysis as per local guidelines).
3) Age: 1 to less than 18 years of age at randomisation
4) Ongoing daily treatment with insulin (any regimen) for at least 3 months prior to Visit 1. No OADs are allowed.
5) HbA1c = 11%
Are the trial subjects under 18? yes
Number of subjects for this age range: 346
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1) Known or suspected hypersensitivity to trial product(s) or related products
2) Previous participation in this trial. Participation is defined as randomisation
3) Girls who are pregnant, breastfeeding or intend to become pregnant
4) Girls, who have had menarche and are not using adequate contraceptive measures according to local requirements
5) Known hypoglycaemic unawareness or recurrent severe hypoglycaemic events as judged by the Investigator
6) More than 1 diabetic ketoacidosis requiring hospitalisation within the last 3 months prior to
Visit 1
7) Significant concomitant disease, except for conditions associated with type 1 diabetes mellitus, which in the Investigator’s opinion could interfere with the trial
8) The receipt of any investigational drug within 1 month prior to Visit 1
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To confirm the efficacy of insulin degludec administered once daily plus mealtime insulin aspart in controlling glycaemia with respect to change from baseline in glycosylated haemoglobin (HbA1c) after 26 weeks of treatment. This is done by comparing the difference in change in HbA1c between insulin degludec + insulin aspart and insulin detemir + insulin aspart to a non-inferiority limit of 0.4%, and if non-inferiority is confirmed, to a superiority limit of 0%.;Secondary Objective: • To compare the efficacy and safety between the two treatment arms<br>• To investigate the pharmacokinetics of insulin degludec and insulin detemir in different age groups using a sparse sampling approach and population pharmacokinetic (PK) modelling.;Primary end point(s): Change from baseline in HbA1c (%) (analysed by central laboratory).;Timepoint(s) of evaluation of this end point: After 26 weeks of treatment
- Secondary Outcome Measures
Name Time Method