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Efficacy and Safety of Insulin Aspart in MDI or CSII in Children Below 7 Years of Age With Type 1 Diabetes
Plain-language guide to NCT00571935: phase 4 randomized trial of Insulin (regular human) and Insulin Aspart, 61 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00571935
- Phase
- phase 4
- Status
- completed
- Start
- 2003-08
- Completion (planned or actual)
- 2004-10
- Participants
- 61 (actual)
- Design
- 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
This registered phase 4 trial tested Insulin (regular human) and Insulin Aspart.
This trial is conducted in Europe.
The registry classes the interventions as drug.
Who Took Part
61 actual participants took part.
It was open to people of any sex aged up to 7 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Type 1 diabetes for at least 1 year. Treatment with regular human insulin and insulin NPH for at least 1 month. Receive more than 2 injections daily.
The full record lists 4 inclusion and 3 exclusion criteria; among the exclusions: receipt of investigational product within 6 months prior to trial participation; known or suspected allergy to investigational product; receipt of of insulin aspart within 3 months prior to trial participation.
How the Study Was Run
It was run as a randomized, parallel-group and open-label study.
The participants were allocated by chance, so the Insulin (regular human) group and the comparison group should start out alike.
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 2003-08 with completion listed for 2004-10.
It ran at 5 sites in Poland (5).
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: HbA1c (time frame: after 26 weeks of treatment).
It also tracked 5 secondary outcomes, for example Overall glycaemic control, Occurrence of adverse events, Occurrence of serious adverse events, Frequency of hypoglycaemia episodes and Quality of Life (QoL).
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Insulin (regular human) and Insulin Aspart in 61 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.