Clinical trial NCT00623194: Safety Follow-up on Children and Adolescents With Type 1 Diabetes Treated With Insulin Detemir. An Extension to Trial NN304-1689
Official title: A 52-Week, Multinational, Multi-Centre, Open-Labelled Extension Trial of Insulin Detemir in Children and Adolescents 3-17 Years With Type 1 Diabetes on a Basal-Bolus Regimen With Insulin Aspart as Bolus Insulin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-02-25
Enrollment: 146
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 development.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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).

Primary outcomes:
measure: Insulin Detemir-insulin Aspart Cross-reacting Antibodies
timeFrame: week 0, 52 and 104
Secondary outcomes:
measure: Development of Insulin Detemir Specific Antibodies and Insulin Aspart Specific Antibodies
timeFrame: At 0, 52 and 104 weeks
measure: Glycosylated Haemoglobin A1c (HbA1c)
timeFrame: At 104 weeks
measure: Fasting Plasma Glucose Values
timeFrame: At 104 weeks
measure: Hypoglycaemic Episodes
timeFrame: Weeks 0-104
measure: BMI (Body Mass Index)
timeFrame: At 104 weeks
measure: SD-score (Z-score) for Body Weight
timeFrame: At 104 weeks
measure: Diabetic Ketoacidosis
timeFrame: At 104 weeks
measure: Insulin Dose
timeFrame: At 104 weeks
measure: Laboratory Values: Albumin Serum and Total Protein Serum (g/dL)
timeFrame: At 104 weeks
measure: Laboratory Values: Creatine Serum Umol/L
timeFrame: At 104 weeks
measure: Laboratory Values: Sodium Serum, Potassium Serum and Haemoglobin (mmol/L)
timeFrame: At 104 weeks
measure: Laboratory Values: Alkaline Phosphatase Serum, Alanine Aminotransferase Serum and Lactate Dehydrogenase Serum (U/L)
timeFrame: At 104 weeks
measure: Laboratory Values: Leukocytes and Thrombocytes
timeFrame: At 104 weeks
measure: Fundoscopy/Fundus Photography
timeFrame: at 52 weeks and at 104 weeks
measure: Vital Signs: Blood Pressure
timeFrame: At 104 weeks
measure: Vital Signs: Pulse
timeFrame: At 104 weeks
Other outcomes:
Locations:
city: Pleven
country: Bulgaria
facility: Novo Nordisk Investigational Site
city: Sofia
country: Bulgaria
facility: Novo Nordisk Investigational Site
city: Varna
country: Bulgaria
facility: Novo Nordisk Investigational Site
city: Olomouc
country: Czech Republic
facility: Novo Nordisk Investigational Site
city: Pardubice
country: Czech Republic
facility: Novo Nordisk Investigational Site
city: Prague 5
country: Czech Republic
facility: Novo Nordisk Investigational Site
city: Glostrup
country: Denmark
facility: Novo Nordisk Investigational Site
city: Kolding
country: Denmark
facility: Novo Nordisk Investigational Site
city: Odense
country: Denmark
facility: Novo Nordisk Investigational Site
city: Helsinki
country: Finland
facility: Novo Nordisk Investigational Site
city: Oulu
country: Finland
facility: Novo Nordisk Investigational Site
city: Seinäjoki
country: Finland
facility: Novo Nordisk Investigational Site
city: Turku
country: Finland
facility: Novo Nordisk Investigational Site
city: Paris
country: France
facility: Novo Nordisk Investigational Site
city: Toulouse
country: France
facility: Novo Nordisk Investigational Site
city: Budapest
country: Hungary
facility: Novo Nordisk Investigational Site
city: Miskolc
country: Hungary
facility: Novo Nordisk Investigational Site
city: Skopje
country: Macedonia, The Former Yugoslav Republic of
facility: Novo Nordisk Investigational Site
city: Gdansk
country: Poland
facility: Novo Nordisk Investigational Site
city: Kielce
country: Poland
facility: Novo Nordisk Investigational Site
city: Warszawa
country: Poland
facility: Novo Nordisk Investigational Site
city: Moscow
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Moscow
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Moscow
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Altunizade-Istanbul
country: Turkey
facility: Novo Nordisk Investigational Site
city: Antalya
country: Turkey
facility: Novo Nordisk Investigational Site
city: Istanbul
country: Turkey
facility: Novo Nordisk Investigational Site
city: Izmir
country: Turkey
facility: Novo Nordisk Investigational Site
city: Aberdeen
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Dundee
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Norfolk
country: United Kingdom
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: 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.