Within-subject Variability of Insulin Detemir in Children and Adolescents With Type 1 Diabetes

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01497574
• Other study ID #: NN304-1633
• Secondary ID: 2004-001692-19
• Status: Completed
• Phase: Phase 1
• First received: December 20, 2011
• Last updated: January 27, 2017
• Start date: May 2005
• Est. completion date: October 2005

Study information

• Verified date: January 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial is conducted in Europe. The aim of this trial is to compare the within-subject variability of the pharmacokinetic profiles of insulin detemir and insulin glargine in children and adolescents with type 1 diabetes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: October 2005
• Est. primary completion date: October 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

Inclusion Criteria:

• Type 1 diabetes for at least 12 months

• Body mass index (BMI) for children (6 to 12 years): 15-20 kg/m^2 (both inclusive)

• Body mass index (BMI) for adolescents (13 to 17 years): 18-25 kg/m^2 (both inclusive)

• HbA1c (glycosylated haemoglobin) below 11.0% according to central laboratory results

• Current treatment with insulin at least twice daily

Exclusion Criteria:

• Any significant disease such as endocrine, hepatic, renal, cardiac, neurological, malignant, or pancreatic disease other than diabetes

• Receipt of any investigational product within the last four weeks

• Known or suspected allergy to trial products or related products

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• insulin detemir
On two dosing visits, 0.4 U/kg insulin detemir will be administered followed by 0.4 U/kg insulin glargine after a 24 hours' interval and repeated in opposite order at next dosing visit. Administrated subcutaneously (s.c., under the skin)
• insulin glargine
On two dosing visits, 0.4 U/kg insulin glargine will be administered followed by 0.4 U/kg insulin detemir after a 24 hours' interval and repeated in opposite order at next dosing visit. Administrated subcutaneously (s.c., under the skin)

Locations

Country	Name	City	State
Germany	Novo Nordisk Investigational Site	Hannover

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Danne T, Datz N, Endahl L, Haahr H, Nestoris C, Westergaard L, Fjording MS, Kordonouri O. Insulin detemir is characterized by a more reproducible pharmacokinetic profile than insulin glargine in children and adolescents with type 1 diabetes: results from — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the insulin concentration curve (AUC)
Secondary	Maximum insulin concentration (Cmax)
Secondary	Time to maximum insulin concentration (tmax)
Secondary	Adverse events

External Links

•   Clinical Trials at Novo Nordisk