A Study to Compare the Pharmacokinetics and Pharmacodynamics of LY2963016 to Lantus in Healthy Participants

What Was Tested

This registered phase 1 trial tested Insulin Glargine.

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

Each study period will be approximately 8.5 days (1.5 days for treatment and 7 day washout period).

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

The registry classes the interventions as drug.

Who Took Part

The registry lists 80 actual participants took part.

It was open to people of any sex aged from 18 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, as determined by medical history and physical examination. Male participants: agree to use a reliable method of birth control during the study. Have a body weight of at least 55 kilograms (kg), and body mass index (BMI) of 18.5 to 32.0 kilograms/square meter (kg/m²). Have clinical laboratory test results within normal reference range for the population. Have venous access sufficient to allow for blood sampling.

The full record lists 9 inclusion and 18 exclusion criteria; among the exclusions: have known allergies to heparin, insulin glargine, related compounds or any components of the formulation; are persons who have previously received the investigational product in this study, have completed or withdrawn from this study or any other study investigating ly2963016; have an abnormal blood pressure as determined by the investigator.

How the Study Was Run

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

Because people in this Insulin Glargine study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Neither the participants nor the staff measuring them knew who was on Insulin Glargine, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2011-11 with completion listed for 2012-07.

It ran at 1 site in South Africa.

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 80 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.