Phase 3
Completed N=348
Comparison of NPH Insulin and Insulin Detemir in Children and Adolescents With Type 1 Diabetes
Diabetes · Diabetes Mellitus, Type 1
Source: ClinicalTrials.gov NCT00435019 ↗
Enrolled (actual)
348
Serious AEs
9.8%
Results posted
Dec 2009
Primary outcomePrimary: Glycosylated Haemoglobin A1c (HbA1c) — 8.75; 8.64 Percent (%) glycosylated haemoglobin
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Glycosylated Haemoglobin A1c (HbA1c) |
8.75; 8.64 | — |
| SECONDARY Number of Subjects Reporting Adverse Events |
132; 135 | — |
| SECONDARY Observed Insulin Antibody Values |
3.23; 2.95; 5.15; 3.01; 27.06; 27.26 | — |
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
Data sourced from ClinicalTrials.gov (NCT00435019). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.