A trial investigating the efficacy and safety of insulin degludec/insulin aspart once daily plus insulin aspart for the remaining meals versus insulin detemir once or twice daily plus meal time insulin aspart in children and adolescents with type 1 diabetes mellitus
- Conditions
- Diabetes Mellitus, Type 1MedDRA version: 16.0Level: LLTClassification code 10045228Term: Type I diabetes mellitusSystem Organ Class: 100000004861Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2012-003566-41-SI
- 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 obtained before any trial related activities. Trial related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
2) Subjects diagnosed with type 1 diabetes mellitus
3) Age: 1 to <18 years of age at randomisation
4) HbA1c = 11.0%
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 hypoglycaemic unawareness or recurrent severe hypoglycaemic events as judged by the investigator
2) More than 1 episode of diabetic ketoacidosis requiring hospitalisation within the last 3 months prior to Visit 1 (Screening)
3) Any chronic disorder or significant concomitant disease, which in the investigator’s opinion might jeopardise the subject’s safety or compliance with the protocol
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