Comparison of NPH Insulin and Insulin Detemir in Children and Adolescents With Type 1 Diabetes

Diabetes Clinical Trial

Official title:

An Efficacy and Safety Comparison of Insulin Detemir vs. NPH Insulin in Children and Adolescents Diagnosed With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00435019
• Other study ID #: NN304-1689
• Secondary ID: 2006-000051-18
• Status: Completed
• Phase: Phase 3
• First received: February 13, 2007
• Last updated: November 20, 2014
• Start date: February 2007
• Est. completion date: September 2008

Study information

• Verified date: November 2014
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Russia: Federal Service for control in Health and Social developmentTurkey: Ministry of Health Drug and Pharmaceutical DepartmentDenmark: Danish Medicines AgencyHungary: National Institute of PharmacyFinland: Finnish Medicines AgencyBulgaria: Bulgarian Drug AgencyCzech Republic: State Institute for Drug ControlPoland: The Office for Registration of Medicinal Products, Medical Devices; and Biocides, Central Evidence of Clinical TrialsMacedonia, The Former Yugoslav Republic of: Drug Agency, Ministry of HealthUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

This trial is conducted in Europe.

The aim of this research is to compare the efficacy and safety of treatment with NPH insulin and insulin detemir. You will be treated with either insulin detemir or NPH insulin once or twice daily as basal insulin. Additionally you will receive insulin aspart as bolus insulin

Recruitment information / eligibility

• Status: Completed
• Enrollment: 348
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 16 Years

Eligibility

Inclusion Criteria:

• Insulin detemir naive

• Type 1 diabetes for at least 12 months

• HbA1c lesser than or equal to 11.0%

Exclusion Criteria:

• Significant concomitant diseases

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• insulin detemir
s.c. injection, once or twice daily.
• insulin NPH
s.c. injection, once or twice daily.
• insulin aspart
s.c. injection, at main meals.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Bulgaria,  Czech Republic,  Denmark,  Finland,  France,  Hungary,  Macedonia, The Former Yugoslav Republic of,  Poland,  Russian Federation,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycosylated Haemoglobin A1c (HbA1c)	Glycosylated haemoglobin A1c (HbA1c) measured after 52 weeks of treatment and analysed by central laboratory.	after 52 weeks of treatment	No
Secondary	Number of Subjects Reporting Adverse Events	Number of subjects reporting adverse events during the trial (from week -2 to week 52).; For details, please refer to the adverse events section.	from week -2 to week 52	Yes
Secondary	Observed Insulin Antibody Values	Observed insulin antibody values for insulin detemir specific antibodies, insulin aspart specific antibodies and insulin detemir/insulin aspart cross-reacting antibodies.	at 0 and 52 weeks	Yes

External Links

•   Clinical Trials at Novo Nordisk