A Study of LY2963016 in Healthy Participants

What Was Tested

In this phase 1 trial, researchers set out to test Insulin Glargine.

This study involves 2 single injections of LY2963016 and 2 single injections of Lantus.

There will be at least 6 days between each injection.

It had four arms (groups): one (experimental), one (experimental), one (experimental) and one (experimental).

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 21 years up to 65 years.

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

Examples of who could join: Healthy males or females. Women must be either surgically sterile, post-menopausal, or agree to use a reliable method of birth control during the study. Have a body mass index between 18.5 and 29.9 kilograms per meter squared (kg/m²). Are nonsmokers and have not smoked for at least 6 months prior to entering the study. Have normal blood pressures and pulse rates at screening, as determined by the investigator.

The full record lists 10 inclusion and 13 exclusion criteria; among the exclusions: are persons who have previously completed or withdrawn from this study; have known allergies to insulin, its excipients, or related drugs or have history of relevant allergic reactions of any origin; show evidence of current use of known drugs of abuse or have a history of use within the past year.

How the Study Was Run

It was run as a randomized, crossover and double-blind study.

The participants were allocated by chance, so the Insulin Glargine group and the comparison group should start out alike.

In the crossover set-up each of the participants took both Insulin Glargine and the comparison in turn, acting as their own control.

As a double-blind Insulin Glargine study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2012-07 with completion listed for 2012-09.

It ran at 1 site in Singapore.

Its stated primary purpose is basic science.

What Was Measured

It also tracked 4 secondary outcomes, for example Maximum Glucose Infusion Rate (Rmax) and Total Amount of Glucose Infused (Gtot).

What This Means in Plain Language

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