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Clinical Trials/NCT01835431
NCT01835431CompletedPhase 3

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

Novo Nordisk A/S1 site in 1 country362 target enrollmentStarted: October 17, 2013Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
362
Locations
1
Primary Endpoint
Change From Baseline in HbA1c (Glycosylated Haemoglobin) (%)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
1 Year to 17 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Insulin degludec/insulin aspart

Experimental

Intervention: insulin degludec/insulin aspart (Drug)

Insulin degludec/insulin aspart

Experimental

Intervention: insulin aspart (Drug)

Insulin detemir

Active Comparator

Intervention: insulin detemir (Drug)

Insulin detemir

Active Comparator

Intervention: insulin aspart (Drug)

Outcomes

Primary Outcomes

Change From Baseline in HbA1c (Glycosylated Haemoglobin) (%)

Time Frame: 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 Outcomes

  • Incidence of Treatment Emergent Adverse Events (TEAEs)(After 16 weeks of 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)
  • Number of Treatment Emergent Nocturnal Confirmed Hypoglycaemic Episodes(After 16 weeks of treatment)
  • Change From Baseline in Fasting Plasma Glucose(week 0, week 16)
  • Number of Treatment Emergent Confirmed Hypoglycaemic Episodes (Plasma Glucose (PG) Below 3.1mmol/L (56mg/dL) or Severe Hypoglycaemia)(After 16 weeks of treatment)
  • Number of Hyperglycaemic Episodes (PG Above 14.0 mmol/L (250 mg/dL) Where Subject Looks/Feels Ill(After 16 weeks of treatment)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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