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A Trial Investigating the Efficacy and Safety of Insulin Degludec in Children and Adolescents With Type 1 Diabetes Mellitus

NCT01513473 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2019-06-13

Study results available
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Summary

This trial is conducted in Africa, Asia, Europe and the United States of America (USA).

The aim of this trial is to investigate the efficacy and safety of insulin degludec in children and adolescents with type 1 diabetes mellitus.

Conditions

Interventions

DRUG

insulin degludec

Injected subcutaneously (under the skin) once daily. Dose individually adjusted.

DRUG

insulin detemir

Injected subcutaneously (under the skin) once or twice daily. Dose individually adjusted.

DRUG

insulin aspart

Injected subcutaneously (under the skin) as mealtime bolus insulin. 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
2012-01-16
Primary Completion
2013-07-30
Completion
2013-07-30

Countries

  • United States
  • Bulgaria
  • Finland
  • France
  • Germany
  • Italy
  • Japan
  • Netherlands
  • North Macedonia
  • Russia
  • South Africa
  • United Kingdom

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 NCT01513473 on ClinicalTrials.gov