A 52-Week, Multinational, Multi-Centre, Open-LabelledExtension Trial of Insulin Detemir in Children andAdolescents 3-17 years with Type 1 Diabetes on a Basal-Bolus Regimen with Insulin Aspart as Bolus InsulinTrial Phase: 3b
- Conditions
- Type 1 DiabetesMedDRA version: 8.1Level: LLTClassification code 10045228Term: Type I diabetes mellitus
- Registration Number
- EUCTR2006-002478-23-HU
- Lead Sponsor
- ovo Nordisk A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 120
1.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.
2. Finalised 52 weeks of treatment with insulin detemir in trial NN304-1689.
3.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.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Significant concomitant disease such as endocrine, hepatic, renal, cardiac, respiratory,
neurological, gastrointestinal, malignant or pancreatic diseases as judged by the Investigator.
2. Pregnant or the intention of becoming pregnant.
3. Previous participation in this trial (defined as enrolment).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method