A Study to Compare LY2963016 and US-approved Lantus® After Single Dose Administration to Healthy Participants

What Was Tested

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

The study will have 4 periods.

It had two arms (groups): LY2963016 (experimental) and US-approved Lantus (experimental).

The registry classes the interventions as drug.

Who Took Part

91 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: Are overtly healthy males or females. Have body mass index between 18.5 and 29.9 kilograms per meter square (kg/m\^2). Are nonsmokers and have not smoked for at least 2 months prior to entering the study. Have normal blood pressure and pulse rates at screening. Have electrocardiograms (ECGs) at screening considered as within normal limits.

The full record lists 6 inclusion and 11 exclusion criteria; among the exclusions: 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 a history of use within the past year; have a history of first-degree relatives known to have diabetes mellitus.

How the Study Was Run

The set-up was randomized, crossover and double-blind.

Random assignment meant chance, not the researchers, decided who got Insulin Glargine and who got the comparison, which limits bias.

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

Blinding on both sides kept the participants and researchers unaware of who received Insulin Glargine.

Those kept unaware of assignments: participant and investigator.

It started in 2012-09 with completion listed for 2013-02.

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 Amount of Glucose Infused (Gtot) Over the Duration of Clamp Procedure.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Glargine in 91 people.

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.