A Comparison of LY2963016 to a Basal Insulin After a Single Dose in Healthy Subjects

What Was Tested

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

The study will also gather information on the safety and tolerability of LY2963016 in healthy subjects.

The study is approximately 12 weeks.

It had two arms (groups): LY2963016 (experimental) and Lantus (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 16 actual participants took part.

It was open to people of any sex aged from 21 years up to 60 years.

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

Examples of who could join: Are overtly healthy males or females. Have a body mass index (BMI) between 18.5 and 29.9 kilogram per square meter (kg/m\^2). Have normal blood pressure and pulse rate. Have an electrocardiogram (ECG) considered as within normal limits. Have clinical laboratory test results within normal reference range.

The full record lists 6 inclusion and 9 exclusion criteria; among the exclusions: are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device; have known allergies to insulin or its excipients; have a history of first-degree relatives known to have diabetes mellitus.

How the Study Was Run

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

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.

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

It started in 2011-06 with completion listed for 2011-07.

It ran at 1 site in Singapore.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 5 secondary outcomes, for example Maximum Glucose Infusion Rate (Rmax), Total Glucose Infused (Gtot) and Time of Maximum Glucose Infusion Rate (tRmax).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Glargine in 16 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.