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Transdermal Insulin Response In Healthy Volunteers
Plain-language guide to NCT04857320: early phase 1 interventional trial of Insulin (regular human), 7 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT04857320
- Phase
- early phase 1
- Status
- completed
- Start
- 2021-03-12
- Completion (planned or actual)
- 2021-11-15
- Participants
- 7 (actual)
- Design
- na, open label (everyone knows who gets what), device_feasibility
- Conditions studied
- Pharmacodynamic Response to Small Doses of Insulin
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
The trial (early phase 1) is built around Insulin (regular human).
Bio-fermentation produced Human insulin is available without prescription in the U.S.
It had 1 arm (groups): Main Experimental (experimental).
The registry classes the interventions as combination product.
Who Took Part
The registry lists 7 actual participants took part.
It was open to men only aged from 20 years up to 60 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: The subject has a serum protein HbA1c of less than 6. The subject is willing and able to read, understand the Subject Information Sheet and provide written informed consent. The subject has a body mass index (BMI) within 18-50 kg/m2. The subject is in otherwise good health as determined by medical history and physical examination. The subject is a non-smoker.
The full record lists 8 inclusion and 9 exclusion criteria; among the exclusions: the subject has a known allergy or history of hypersensitivity to human insulin or similar modified insulin compounds; the subject has used any prescription medication that may interfere with the evaluation of study medication; the subject has a history of substance abuse or a current positive urine drug screen or urine alcohol test.
How the Study Was Run
Design: single-group and open-label.
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.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2021-03-12 with completion listed for 2021-11-15.
It ran at 1 site in United States.
Its stated primary purpose is device feasibility.
What This Means in Plain Language
Put simply, this is a early phase 1 trial of Insulin (regular human) in 7 people.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
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.