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Comparison of Human Insulin to Insulin Inhalation Solution in Children With Type 1 Diabetes
Plain-language guide to NCT00567775: phase 2 randomized trial of Insulin (regular human), 27 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00567775
- Phase
- phase 2
- Status
- completed
- Start
- 2002-10-21
- Completion (planned or actual)
- 2002-11-20
- Participants
- 27 (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
In this phase 2 trial, researchers set out to test Insulin (regular human).
This trial is conducted in Europe.
The registry classes the interventions as drug.
Who Took Part
27 actual participants took part.
It was open to people of any sex aged from 6 years up to 17 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Type 1 diabetes. Treatment for at least 12 months. Body weight between 25 and 80 Kg. Capable to use the device.
The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: any diseases other than diabetes requiring prescriptive medication; known or suspected allergy to trial product or related products; active proliferative retinopathy as judged by the investigator.
How the Study Was Run
The set-up was randomized, crossover and open-label.
The participants were allocated by chance, so the Insulin (regular human) group and the comparison group should start out alike.
In the crossover set-up each of the participants took both Insulin (regular human) and the comparison in turn, acting as their own control.
Nothing was hidden in this open-label Insulin (regular human) study: the participants and staff both knew the treatment.
It started in 2002-10-21 with completion listed for 2002-11-20.
It ran at 1 site in Denmark.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Area under the serum insulin curve.
It also tracked 2 secondary outcomes, for example Maximum serum insulin concentration and Time to maximum serum insulin concentration.
What This Means in Plain Language
Put simply, this is a phase 2, randomized trial of Insulin (regular human) in 27 people.
Its size is small, so on its own it can only give an early look.
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, all human trials.
Our Notes on the Compound
Insulin (regular human): The 51-amino-acid pancreatic hormone that lowers blood glucose; this page covers regular (short-acting) insulin studied in human trials.
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.