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Comparison of NPH Insulin and Insulin Detemir in Children and Adolescents With Type 1 Diabetes
Plain-language guide to NCT00435019: phase 3 randomized trial of Insulin Aspart and Insulin Detemir, 348 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00435019
- Phase
- phase 3
- Status
- completed
- Start
- 2007-02
- Completion (planned or actual)
- 2008-09
- Participants
- 348 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes; Diabetes Mellitus, Type 1
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
In this phase 3 trial, researchers set out to test Insulin Aspart and Insulin Detemir.
This trial is conducted in Europe.
You will be treated with either insulin detemir or NPH insulin once or twice daily as basal insulin.
It had two arms (groups): insulin detemir (experimental) and NPH insulin (experimental).
Insulin detemir + insulin aspart.
NPH insulin + insulin aspart.
The registry classes the interventions as drug.
Who Took Part
Enrollment: 348 actual participants took part.
It was open to people of any sex aged from 2 years up to 16 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Insulin detemir naive. Type 1 diabetes for at least 12 months.
The full record lists 3 inclusion and 1 exclusion criteria.
How the Study Was Run
Design: randomized, parallel-group and open-label.
Random assignment meant chance, not the researchers, decided who got Insulin Aspart and who got the comparison, which limits bias.
The Insulin Aspart group and the comparison group ran side by side rather than switching.
Being open-label, the Insulin Aspart study did not mask who received what.
It started in 2007-02 with completion listed for 2008-09.
It ran at 43 sites in Finland (6), Poland (6), Turkey (Türkiye) (5), United Kingdom (5), Denmark (4) and France (4).
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Glycosylated Haemoglobin A1c (HbA1c) (time frame: after 52 weeks of treatment).
It also tracked 2 secondary outcomes, for example Number of Subjects Reporting Adverse Events and Observed Insulin Antibody Values.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Insulin Aspart and Insulin Detemir in 348 people.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
More context: the Insulin Aspart compound page and the Insulin Detemir compound page, all human trials.
Our Notes on the Compounds
Insulin Aspart: A rapid-acting mealtime insulin analog; brands include NovoLog, NovoRapid and Fiasp.
Insulin Detemir: A long-acting basal insulin analog sold as Levemir.
NPH Insulin (isophane): An intermediate-acting insulin made by combining insulin with protamine; also called isophane or NPH insulin (Humulin N, Novolin N).
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.