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

Phase 3 Completed 146 enrolled Novo Nordisk A/S

Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2008-02
Primary completion: 2009-09
Completion: 2009-09

Publications

Background Thalange N, Bereket A, Jensen LB, Hiort LC, Peterkova V. Development of Insulin Detemir/Insulin Aspart Cross-Reacting Antibodies Following Treatment with Insulin Detemir: 104-week Study in Children and Adolescents with Type 1 Diabetes Aged 2-16 Years. Diabetes Ther. 2016 Dec;7(4):713-724. doi: 10.1007/s13300-016-0196-5. Epub 2016 Sep 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	insulin detemir	Protein / enzyme biologic	—	Subcutaneous
Background	insulin aspart	Protein / enzyme biologic	—	Subcutaneous

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

Summary

Timeline

Publications

Drugs

Indications