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

Phase 3

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 1
• Interventions: Drug: insulin detemir; Drug: insulin NPH; Drug: insulin aspart

• Registration Number: NCT00435019
• Lead Sponsor: Novo Nordisk A/S

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2007-02-13
• Study First Submitted QC: 2007-02-13
• Study First Posted: 2007-02-14
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Results First Submitted: 2009-11-03
• Results First Submitted QC: 2009-11-03
• Results First Posted: 2009-12-08
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-30
• Last Update Posted: 2017-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 348

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
insulin detemir	insulin aspart	insulin detemir + insulin aspart
NPH insulin	insulin aspart	NPH insulin + insulin aspart
insulin detemir	insulin detemir	insulin detemir + insulin aspart
NPH insulin	insulin NPH	NPH insulin + insulin aspart

Primary Outcome Measures

Name	Time	Method
Glycosylated Haemoglobin A1c (HbA1c)	after 52 weeks of treatment	Glycosylated haemoglobin A1c (HbA1c) measured after 52 weeks of treatment and analysed by central laboratory.

Secondary Outcome Measures

Name	Time	Method
Number of Subjects Reporting Adverse Events	from week -2 to week 52	Number of subjects reporting adverse events during the trial (from week -2 to week 52).; For details, please refer to the adverse events section.
Observed Insulin Antibody Values	at 0 and 52 weeks	Observed insulin antibody values for insulin detemir specific antibodies, insulin aspart specific antibodies and insulin detemir/insulin aspart cross-reacting antibodies.

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇬🇧 Norfolk, United Kingdom