A Study of Insulin Glargine (LY2963016) in Healthy Chinese Participants

What Was Tested

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

The purpose of this study is to compare a study drug known as Insulin glargine with Lantus in healthy Chinese participants.

Blood samples will be taken to compare how the body handles the drugs and how they affect blood sugar levels.

Side effects and tolerability will be documented.

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

The registry classes the interventions as drug.

Who Took Part

58 actual participants took part.

It was open to people of any sex aged from 18 years up to 40 years.

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

Examples of who could join: Are native Chinese men or women. Native Chinese is defined as a participant who has both parents and all 4 grandparents of Chinese origin. For females of childbearing potential (defined as not surgically sterilised and between menarche and 1-year postmenopause) only:. Negative serum pregnancy test at the time of screening. Are not lactating. Intend not to become pregnant during the study.

The full record lists 16 inclusion and 8 exclusion criteria; among the exclusions: have a history of first-degree relatives known to have diabetes mellitus; have known allergies to insulin glargine or its excipients, or related drugs, or heparin, or have a history of relevant allergic reactions of any origin; show evidence of human immunodeficiency virus infection (hiv) and/or positive human hiv antibodies.

How the Study Was Run

It was run as a randomized, crossover and open-label study.

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.

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 2018-09-26 with completion listed for 2019-11-04.

It ran at 1 site in China.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): PK: Area Under the Concentration Versus Time Curve From Time Zero to 24 Hours (AUC[0-24]) of Insulin Glargine and Lantus (time frame: -0.5 and 0 hours predose; 0.5, 1, 2, 3, 4, 6, 9, 12, 15, 18, 21, and 24 hours postdose).

It also tracked 2 secondary outcomes, for example PD: Maximum Glucose Infusion Rate (Rmax).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Glargine in 58 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.