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-CZ
- 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 Main Objective: To confirm the efficacy of insulin degludec/insulin aspart administered once daily plus meal-time insulin aspart for the remaining meals in controlling glycaemia with respect to change from baseline in HbA1c after 16 weeks of treatment. This is done by comparing the difference in change from baseline in HbA1c between insulin degludec/insulin aspart + meal-time insulin aspart for the remaining meals and insulin detemir + meal-time 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 groups after 16 weeks of treatment;Primary end point(s): Change from baseline in HbA1c (%) ;Timepoint(s) of evaluation of this end point: After 16 weeks of treatment
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Change from baseline in fasting plasma glucose<br>- Incidence of treatment emergent adverse events (TEAEs)<br>- Hypoglycaemia:<br> - Number of treatment emergent confirmed hypoglycaemic episodes (PG<3.1 mmol/L (56 mg/dL) or severe hypoglycaemia )<br> - Number of treatment emergent nocturnal confirmed hypoglycaemic episodes<br>- Hyperglycaemia:<br> - Number of hyperglycaemic episodes (PG > 14.0 mmol/L (250 mg/dL) where subject looks/feels ill<br> - Number of hyperglycaemic episodes (PG > 14.0 mmol/L (250 mg/dL) where subject looks/feels ill with ketosis (blood ketones > 1.5 mmol/L);Timepoint(s) of evaluation of this end point: After 16 weeks of treatment