Phase 3
Completed N=362
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
Diabetes · Diabetes Mellitus, Type 1
Source: ClinicalTrials.gov NCT01835431 ↗
Enrolled (actual)
362
Serious AEs
5.0%
Results posted
Nov 2015
Primary outcomePrimary: Change From Baseline in HbA1c (Glycosylated Haemoglobin) (%) — -0.3; -0.3 percentage (%)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in HbA1c (Glycosylated Haemoglobin) (%) |
-0.3; -0.3 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose |
-0.3; -0.1 | — |
| SECONDARY Incidence of Treatment Emergent Adverse Events (TEAEs) |
501; 460 | — |
| SECONDARY Number of Treatment Emergent Confirmed Hypoglycaemic Episodes (Plasma Glucose (PG) Below 3.1mmol/L (56mg/dL) or Severe Hypoglycaemia) |
2532; 2672 | — |
| SECONDARY Number of Treatment Emergent Nocturnal Confirmed Hypoglycaemic Episodes |
316; 291 | — |
| SECONDARY Number of Hyperglycaemic Episodes (PG Above 14.0 mmol/L (250 mg/dL) Where Subject Looks/Feels Ill |
599; 449 | — |
| SECONDARY 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) |
6; 12 | — |
Eligibility Criteria
Inclusion Criteria: - 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% Exclusion Criteria: - 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
Data sourced from ClinicalTrials.gov (NCT01835431). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.