A Study of LY2605541 (Insulin Peglispro) and Human Insulin Concentrations in Fat Tissue

What Was Tested

In this phase 1 trial, researchers set out to test Insulin (regular human).

LY2605541 is an investigational drug being developed for the treatment of diabetes mellitus.

This study is designed to understand how the body handles the investigational drug, and to measure the quantity of LY2605541 in fat tissue.

The study has two parts.

It had two arms (groups): Insulin Peglispro (LY2605541) (experimental) and Human Insulin (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 24 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Have a diagnosis of Type 1 Diabetes Mellitus (T1DM) based on medical history for at least 1 year prior to enrollment. Have a c-peptide value ≤0.3 nanomoles per liter (nmol/L) at screening. Have a serum creatinine value within normal limits at screening. Have a body mass index (BMI) of 20.0-30.0 kilograms per meter squared (kg/m\^2), inclusive, at screening.

The full record lists 5 inclusion and 17 exclusion criteria; among the exclusions: have known or suspected allergies or hypersensitivities to ly2605541, human insulin, sinistrin, related compounds or any components of the formulations; are women who are pregnant or lactating; have an abnormal blood pressure for the population as determined 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.

Being open-label, the Insulin (regular human) study did not mask who received what.

It started in 2014-04 with completion listed for 2015-03.

It ran at 1 site in Austria.

Its stated primary purpose is basic science.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin (regular human) in 24 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.