Status:
COMPLETED
Safety Follow-up on Children and Adolescents With Type 1 Diabetes Treated With Insulin Detemir. An Extension to Trial NN304-1689
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 1
Eligibility:
All Genders
3-17 years
Phase:
PHASE3
Brief 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 d...
Eligibility Criteria
Inclusion
- Informed Consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject). The parents or legal representative of the subject must sign and date the Informed Consent Form.
- Finalised 52 weeks of treatment with insulin detemir in trial NN304-1689.
- Fertile females (girls who have had their first menstrual period) must use adequate contraception (barrier methods, contraceptive pills or intrauterine device (IUD)) if there is any risk of pregnancy in the opinion of the Investigator. For Denmark and France only contraceptive pills or intrauterine device are considered as adequate contraceptive methods.
Exclusion
- Significant concomitant disease such as endocrine, hepatic, renal, cardiac, respiratory, neurological, gastrointestinal, malignant or pancreatic diseases as judged by the Investigator.
- Pregnant or the intention of becoming pregnant.
- Previous participation in this trial (defined as enrolment).
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT00623194
Start Date
February 1 2008
End Date
September 1 2009
Last Update
November 28 2016
Active Locations (32)
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1
Novo Nordisk Investigational Site
Pleven, Bulgaria, 5800
2
Novo Nordisk Investigational Site
Sofia, Bulgaria, 1606
3
Novo Nordisk Investigational Site
Varna, Bulgaria, 9010
4
Novo Nordisk Investigational Site
Olomouc, Czechia, 77520