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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

NCT01835431 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 362

Last updated 2019-06-11

Study results available
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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.

Conditions

Interventions

DRUG

insulin degludec/insulin aspart

Administered subcutaneously (s.c., under the skin) once daily with a main meal. Dose individually adjusted.

DRUG

insulin aspart

Administered s.c. with the remaining meals. Dose individually adjusted.

DRUG

insulin detemir

Administered s.c. once or twice daily. Dose individually adjusted. Subjects will continue with their pre-trial dosing scheme (once (OD) or twice daily (BID)) and will be allowed to switch from OD to BID dosing.

DRUG

insulin aspart

Administered s.c. at meal-times. Dose individually adjusted.

Sponsors & Collaborators

Principal Investigators

  • Global Clinical Registry (GCR, 1452) · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-17
Primary Completion
2014-11-07
Completion
2014-11-07

Countries

  • United States
  • Belgium
  • Brazil
  • Canada
  • Croatia
  • Czechia
  • India
  • Israel
  • North Macedonia
  • Poland
  • Russia
  • Serbia
  • Slovenia
  • South Africa
  • Spain

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01835431 on ClinicalTrials.gov