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

Study Description

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Brief 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.

Condition or disease	Intervention/treatment	Phase
Diabetes; Diabetes Mellitus, Type 1	Drug: insulin detemir; Drug: insulin glargine	Phase 1

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	32 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
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
Study Start Date :	May 2005
Actual Primary Completion Date :	October 2005
Actual Study Completion Date :	October 2005

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Insulin detemir	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) Drug: 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)
Active Comparator: Insulin glargine	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) Drug: 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)

Outcome Measures

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Primary Outcome Measures :

1. Area under the insulin concentration curve (AUC)

Secondary Outcome Measures :

1. Maximum insulin concentration (Cmax)
2. Time to maximum insulin concentration (tmax)
3. Adverse events

Eligibility Criteria

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Ages Eligible for Study:	6 Years to 17 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Locations

Germany
Novo Nordisk Investigational Site
Hannover, Germany, 30173

Sponsors and Collaborators

Novo Nordisk A/S

Investigators

Study Director:	Global Clinical Registry (GCR, 1452)	Novo Nordisk A/S

More Information

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Additional Information:

Clinical Trials at Novo Nordisk 

Publications of Results:

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 a randomized, double-blind, controlled trial. Pediatr Diabetes. 2008 Dec;9(6):554-60. doi: 10.1111/j.1399-5448.2008.00443.x. Epub 2008 Aug 27.

Responsible Party:	Novo Nordisk A/S
ClinicalTrials.gov Identifier:	NCT01497574 History of Changes
Other Study ID Numbers:	NN304-1633; 2004-001692-19 ( EudraCT Number )
First Posted:	December 22, 2011
Last Update Posted:	January 30, 2017
Last Verified:	January 2017

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 1; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases	Insulin, Globin Zinc; Insulin; Insulin Glargine; Insulin Detemir; Hypoglycemic Agents; Physiological Effects of Drugs