A trial investigating the efficacy and safety of insulin degludec in children and adolescents with type 1diabetes mellitus
- Conditions
- Diabetes Mellitus, Type 1MedDRA version: 14.1Level: LLTClassification code 10045228Term: Type I diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2011-003148-39-BG
- 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
- Secondary Outcome Measures
Name Time Method