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Safety Follow-up on Children and Adolescents With Type 1 Diabetes Treated With Insulin Detemir. An Extension to Trial NN304-1689

NCT00623194 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2016-11-28

Study results available
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Summary

This trial is conducted in Europe. The aim of this research is to assess the safety of continuous treatment with insulin detemir following participation in trial NN304-1689 (NCT00435019) on antibody development.

Conditions

Interventions

DRUG

insulin detemir

Treat-to-target dose titration scheme (individually adjusted), injection s.c. (under the skin), once or twice daily.

DRUG

insulin aspart

Treat-to target dose titration scheme (individually adjusted), injection s.c. (under the skin), at larger meals.

Sponsors & Collaborators

Principal Investigators

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

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2009-09-30
Completion
2009-09-30

Countries

  • Bulgaria
  • Czechia
  • Denmark
  • Finland
  • France
  • Hungary
  • North Macedonia
  • Poland
  • Russia
  • Turkey (Türkiye)
  • 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 NCT00623194 on ClinicalTrials.gov