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
- DiabetesDiabetes Mellitus, Type 1
- Interventions
- Registration Number
- NCT01835431
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This trial is conducted in Asia, Europe and North and South America. The aim of the trial is to investigate the efficacy and safety of insulin degludec/insulin aspart once daily plus insulin aspart for the remaining meals in children and adolescents with type 1 diabetes mellitus.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 362
- 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 - Subjects diagnosed with type 1 diabetes mellitus - HbA1c below or equal to 11.0%
- Known hypoglycaemic unawareness or recurrent severe hypoglycaemic events as judged by the investigator - More than 1 episode of diabetic ketoacidosis requiring hospitalisation within the last 3 months prior to Visit 1 (Screening) - 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
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Insulin detemir insulin aspart - Insulin degludec/insulin aspart insulin degludec/insulin aspart - Insulin detemir insulin detemir - Insulin degludec/insulin aspart insulin aspart -
- Primary Outcome Measures
Name Time Method Change From Baseline in HbA1c (Glycosylated Haemoglobin) (%) Week 0 to week 16 Percentage point change in glycosylated haemoglobin A1c (HbA1c) from baseline (week 0) to 16 Weeks. Change from baseline summary statistics at week 16 contains only those who had both baseline and week 16 assesment.
- Secondary Outcome Measures
Name Time Method Incidence of Treatment Emergent Adverse Events (TEAEs) After 16 weeks of treatment A Treatment Emergent Adverse Event (TEAE) was defined as an event with onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day on randomised treatment.
Number of Hyperglycaemic Episodes (PG Above 14.0 mmol/L (250 mg/dL) Where Subject Looks/Feels Ill With Ketosis (Blood Ketones Above 1.5 mmol/L) After 16 weeks of treatment The episode of hyperglycaemia was noted when the glucose measurement was 14.0mmol/L or above and the subject looked /felt ill. The ketone meaurement involved an additional finger prick and ketosis was considered present if blood ketones were higher than 1.5mmol/L
Number of Treatment Emergent Nocturnal Confirmed Hypoglycaemic Episodes After 16 weeks of treatment The confirmed hypoglycaemic episodes occurring between 23:00 and 07:00 were considered for this endpoint
Change From Baseline in Fasting Plasma Glucose week 0, week 16 Change from baseline in FPG after 16 weeks of treatment. Change from baseline summary statistics at week 16 contains only those who had both baseline and week 16 assesment.
Number of Treatment Emergent Confirmed Hypoglycaemic Episodes (Plasma Glucose (PG) Below 3.1mmol/L (56mg/dL) or Severe Hypoglycaemia) After 16 weeks of treatment Treatment emergent hypoglycaemic episodes (PG \< 3.1 mmol/L (56 mg/dL) or severe hypoglycaemia).
Confirmed hypoglycaemic episodes were defined as episodes that were either:
1. Severe (i.e. the child is having altered mental status and cannot assist in their care, is semiconscious or unconscious or in coma with or without convulsions and may require parenteral therapy (glucagon or i.v. glucose), or
2. An episode biochemically confirmed by PG value of \<3.1 mmol/L (56 mg/dL), with or without symptoms consistent with hypoglycaemia.Number of Hyperglycaemic Episodes (PG Above 14.0 mmol/L (250 mg/dL) Where Subject Looks/Feels Ill After 16 weeks of treatment The episode of hyperglycaemia was noted when the glucose measurement was 14.0mmol/L or above and the subject looked /felt ill.
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇪🇸Madrid, Spain