A single-centre, randomised, double-blind, cross-over trial comparing the within-subject variability of the pharmacokinetic profiles of insulin detemir and insulin glargine in children and adolescents with type 1 diabetes

• Conditions: Type I Diabetes; MedDRA version: 7.0Level: PTClassification code 10012608

• Registration Number: EUCTR2004-001692-19-DE
• Lead Sponsor: ovo Nordisk AS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05-13
• Last Update Posted: 10 February 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Informed consent obtained from the subject (and the subject’s parents or legally accepted representatives) before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.)
2.Type 1 diabetes for at least 12 months
3.Boys and girls between 6 and 17 years (both inclusive)
4.Body mass index (BMI) for children (6 to 12 years): 15-24 kg/m2 (both inclusive), for adolescents (13 to 17 years): 18-29 kg/m2 (both inclusive)
5.HbA1c < 11.0% according to central laboratory results
6.Current treatment with insulin at least twice daily
7.Total daily insulin dosage = 0.6 U/kg
8.Considered generally healthy upon completion of medical history and physical examination as judged by the Investigator
9.Fertile girls must use an acceptable method of contraception if there is any risk of pregnancy during the trial. Acceptable methods are oral contraceptive, intrauterine device (IUD) or implants.

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

1.Any significant disease such as endocrine disease other than thyroiditis (treated or no treatment necessary), hepatic, renal, cardiac, neurological, malignant, or pancreatic disease other than diabetes
2.Receipt of any investigational product within the last four weeks
3.Biochemical signs of hepatic diseases as indicated by values for alanine aminotransferase (ALAT) above two times the upper reference limit (according to the central laboratory)
4.Biochemical signs of renal diseases as indicated by values for creatinine outside normal ranges for the respective age group (according to the central laboratory)
5.Regular use of any systemic prescription medicines other than insulin, inhaled corticosteroids or oral contraceptive
6.Persistent micro-albuminuria or background or proliferative retinopathy as judged by the Investigator
7.Known or suspected allergy to trial products or related products
8.A life-style incompatible with the trial, as judged by the Investigator, e.g. highly variable eating habits
9.Pregnancy, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures (oral contraceptive, IUD or implants)
10.Any disease, condition, mental disorder, unwillingness or language barrier that may interfere with the trial, as determined at the discretion of the Investigator
11.Previous randomisation in this trial
12.Blood donation of more than 500 mL within the last 12 weeks

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified