NCT00435019
Completed
Phase 3
An Efficacy and Safety Comparison of Insulin Detemir vs. NPH Insulin in Children and Adolescents Diagnosed With Type 1 Diabetes
Overview
- Phase
- Phase 3
- Intervention
- insulin detemir
- Conditions
- Diabetes
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 348
- Locations
- 1
- Primary Endpoint
- Glycosylated Haemoglobin A1c (HbA1c)
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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
Investigators
Eligibility Criteria
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
Arms & Interventions
insulin detemir
insulin detemir + insulin aspart
Intervention: insulin detemir
insulin detemir
insulin detemir + insulin aspart
Intervention: insulin aspart
NPH insulin
NPH insulin + insulin aspart
Intervention: insulin NPH
NPH insulin
NPH insulin + insulin aspart
Intervention: insulin aspart
Outcomes
Primary Outcomes
Glycosylated Haemoglobin A1c (HbA1c)
Time Frame: after 52 weeks of treatment
Glycosylated haemoglobin A1c (HbA1c) measured after 52 weeks of treatment and analysed by central laboratory.
Secondary Outcomes
- Number of Subjects Reporting Adverse Events(from week -2 to week 52)
- Observed Insulin Antibody Values(at 0 and 52 weeks)
Study Sites (1)
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