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Comparison of Antibody Levels in Children and Adolescents After Initiation of Insulin Therapy by Either Insulin Aspart or Soluble Human Insulin
Plain-language guide to NCT00410033: not phased non-randomized trial of Insulin (regular human) and Insulin Aspart, 74 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00410033
- Phase
- not phased
- Status
- completed
- Start
- 1989-12
- Completion (planned or actual)
- 2006-05
- Participants
- 74 (actual)
- Design
- non-randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes; Diabetes Mellitus, Type 1
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (not phased) is built around Insulin (regular human) and Insulin Aspart.
This trial is conducted in Europe.
This is a single-centre, retrospective trial aiming at comparing the antibody levels in children and adolescents.
The registry classes the interventions as drug.
Who Took Part
Enrollment: 74 actual participants took part.
It was open to people of any sex aged from 2 years up to 17 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Informed consent obtained before any trial-related activities. Any subjects at onset of Type 1 Diabetes.
The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: treatment with immunosuppressive agents; for the soluble human insulin and isophane human insulin group: treatment with insulin analogues; other diseases influencing immune response.
How the Study Was Run
Design: non-randomized, parallel-group and open-label.
The Insulin (regular human) group and the comparison group ran side by side rather than switching.
Everyone knew when Insulin (regular human) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
It started in 1989-12 with completion listed for 2006-05.
It ran at 1 site in Sweden.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Insulin aspart specific, human insulin specific and cross reacting antibodies (time frame: measured up to at most 2.5 years after diagnosis).
It also tracked 3 secondary outcomes, for example HbA1c, Insulin requirements and Incidence of hypoglycaemic episodes.
What This Means in Plain Language
Put simply, this is a not phased, non-randomized trial of Insulin (regular human) and Insulin Aspart in 74 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Insulin (regular human) compound page and the Insulin Aspart compound page, all human trials.
Our Notes on the Compounds
Insulin (regular human): The 51-amino-acid pancreatic hormone that lowers blood glucose; this page covers regular (short-acting) insulin studied in human trials.
Insulin Aspart: A rapid-acting mealtime insulin analog; brands include NovoLog, NovoRapid and Fiasp.
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.