A Study of LY2605541 and Insulin Lispro Mixture in Healthy Participants

What Was Tested

The trial (phase 1) is built around Insulin Lispro.

The main purpose of this study is to evaluate how the body absorbs and removes LY2605541, insulin lispro, and a mixture of both from the blood.

The study has two parts.

Participants may enroll in only one part.

It had eight arms (groups): LY2605541-Part A (experimental), Insulin Lispro-Part A (active comparator), LY2605541/Lispro Mix 1-Part A (experimental), LY2605541/Lispro Mix 2-Part A (experimental) and Insulin Lispro-Part B (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 40 planned participants were the target.

It was open to people of any sex aged from 21 years up to 65 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Are not of child-bearing potential. Have a body mass index (BMI) between 18 and 29.9 kilograms per meter squared (kg/m\^2), inclusive. Are nonsmokers or have not smoked for at least 2 months prior to entering the study.

The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: have known allergies to insulin or its excipients, or related drugs, or history of relevant allergic reactions of any origin; have a history of first-degree relatives known to have diabetes mellitus; have used systemic glucocorticoids within 3 months prior to entry into the study.

How the Study Was Run

Design: non-randomized, single-group and open-label.

Being open-label, the Insulin Lispro study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2013-06 with completion listed for 2013-09.

It ran at 1 site in Singapore.

Its stated primary purpose is basic science.

What Was Measured

It also tracked 2 secondary outcomes, for example Maximum Glucose Infusion Rate (Rmax) and Total Glucose Infused Over Clamp Duration (Gtot).

What This Means in Plain Language

Put simply, this is a phase 1, non-randomized trial of Insulin Lispro in 40 people.

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.