Type 1 Diabetes MedDRA version: 8.1 Level: LLT Classification code 10045228 Term: Type I diabetes mellitus
Conditions
Interventions
Trade Name: Levemir
Product Name: Levemir
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Insulin detemir
CAS Number: N
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To study the development of insulin detemir-insulin aspart cross-reacting antibodies following a 104 week-period (52 weeks in NN304-1689 and 52 weeks in NN304-1690) of insulin detemir treatment in children and adolescents ; Secondary Objective: • To study the development of insulin detemir specific antibodies and insulin aspart specific antibodies • To follow the glycaemic control, measured as HbA1c, of insulin detemir administered once or twice daily plus mealtime insulin aspart in children and adolescents with type 1 diabetes. • Fasting plasma glucose values • Incidence of hypoglycaemic episodes (mild, moderate, severe and biochemical) overall, daytime and night-time • BMI and SD-score (z-score) for weight • Incidence of adverse events • Incidence of diabetic ketoacidosis requiring hospitalisation • Insulin dose • Laboratory safety parameters (haematology and biochemistry) and fundoscopy/fundusphotography • Vital signs All secondary objectives will be investigated over a 104 week-period (52 weeks in NN304-1689 and 52 weeks in NN304-1690). ; Primary end point(s): •Insulin antibodies: Insulin detemir specific, insulin aspart specific and insulin detemirinsulin aspart cross-reacting antibodies during treatment • Vital signs, end of trial • Incidence of hypoglycaemia (mild, moderate, severe and biochemical) – total, daytime and night time during treatment • Body weight, BMI, SD-score (z-score) for weight, end of trial • Adverse events during treatment • Insulin dose during treatment • Laboratory safety p | — |
Countries
Bulgaria, Czech Republic, Denmark, Finland, France, Hungary, United Kingdom
Outcome results
None listed