Subcutaneous Pharmacokinetic Evaluation of Monomeric Insulin and Lyumjev in Adults With Type 1 Diabetes

What Was Tested

This registered phase 1 trial tested Insulin Lispro.

Twenty participants will complete three study visits, each separated by at least48 hours.

It had three arms (groups): Diluted Humalog U-200 Insulin (experimental), Diluted Humulin U-500 Insulin (experimental) and Lyumjev U-100 Insulin (active comparator).

The registry classes the interventions as dietary supplement and drug.

More on the Plan

The presence of zinc ions and metacresol in commercial formulations promotes hexamer stability, contributing to slower onset and prolonged duration of action.

Each participant serves as their own control, receiving all three insulin formulations in randomized order across three separate visits.

Results will be presented as median and interquartile range for each parameter.

Safety Considerations The study is categorized as no greater than low risk.

Who Took Part

The registry lists 10 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 18-60 years of age. Clinical diagnosis of type 1 diabetes. On insulin pump therapy and continuous glucose monitor for at least 3 months. For females of childbearing potential, a negative pregnancy test and not attempting to conceive. Understanding and willingness to follow the protocol and sign informed consent.

The full record lists 6 inclusion and 12 exclusion criteria; among the exclusions: diabetic ketoacidosis within 3 months; severe hypoglycemia resulting in seizure or loss of consciousness within 3 months prior to enrollment; have donated blood within 8 weeks.

How the Study Was Run

The set-up was randomized, crossover and open-label.

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.

Everyone knew when Insulin Lispro was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2025-10-28 with completion listed for 2026-05-29.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Time to Maximum Insulin Concentration (Tmax) (time frame: 0 to 360 minutes post-injection). Maximum Plasma Insulin Concentration (Cmax) (time frame: 0 to 360 minutes post-injection). Elimination Half-Life (T1/2) (time frame: 0 to 360 minutes post-injection).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Lispro in 10 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 Lispro compound page, all human trials.