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A Study of LY900014 (Lyumjev) Versus Insulin Lispro (Humalog) in Participants With Type 1 Diabetes
Plain-language guide to NCT05262387: phase 1 randomized trial of Insulin Lispro, 25 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT05262387
- Phase
- phase 1
- Status
- completed
- Start
- 2022-02-14
- Completion (planned or actual)
- 2023-03-07
- Participants
- 25 (actual)
- Design
- randomized, double-blind, basic_science
- Conditions studied
- Diabetes Mellitus, Type 1
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
This registered phase 1 trial tested Insulin Lispro.
The study may last up to approximately 10 weeks and may include up to 7 visits.
It had four arms (groups): Treatment Sequence 1: ADBC (experimental), Treatment Sequence 2: BACD (experimental), Treatment Sequence 3: CBDA (experimental) and Treatment Sequence 4: DCAB (experimental).
The registry classes the interventions as drug.
Who Took Part
The registry lists 25 actual participants took part.
It was open to people of any sex aged from 18 years up to 55 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Male or female participants with type 1 diabetes. Body mass index (BMI) between 18.5 and 29.0 kilograms per square meter (kg/m²), inclusive. Hemoglobin A1c (HbA1c) less than or equal to 8.5 percent (%). Using CSII and stable insulin regimen for at least 6 months prior to inclusion into the trial. Able to undergo at least 1 hour of moderate-intensity exercise.
How the Study Was Run
It was run as a randomized, crossover and double-blind study.
Random assignment meant chance, not the researchers, decided who got Insulin Lispro and who got the comparison, which limits bias.
Each person switched between Insulin Lispro and the comparison at some point, usually with a gap in between.
As a double-blind Insulin Lispro study, the assignments were hidden from both participants and investigators until the end.
Those kept unaware of assignments: participant and investigator.
It started in 2022-02-14 with completion listed for 2023-03-07.
It ran at 1 site in Canada.
Its stated primary purpose is basic science.
What This Means in Plain Language
Put simply, this is a phase 1, randomized trial of Insulin Lispro in 25 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 Lispro compound page, all human trials.
Our Notes on the Compound
Insulin Lispro: A rapid-acting mealtime insulin analog; brands include Humalog, Admelog and Lyumjev.
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.