A Study of LY3209590 in Healthy Participants and Participants With Type 2 Diabetes

What Was Tested

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

This trial is conducted to evaluate the safety of a study drug given by injection under the skin to healthy participants and participants with type 2 diabetes.

It will also investigate how the body processes the study drug and the effect of the study drug on blood sugar levels.

Information about any side effects and tolerability will be documented.

It had three arms (groups): LY3209590 (experimental), Placebo (placebo comparator) and Insulin Glargine (Lantus) (active comparator).

LY3209590 administered subcutaneously (SC).

Placebo (sterile saline) administered SC.

Insulin Glargine administered SC.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 80 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Must be a male, or a female who cannot become pregnant, and who is either a healthy participant, or who has type 2 diabetes for at least 1 year. Have a body mass index (BMI) of greater than 18.5 kilogram per square meter (kg/m²) and less than or equal to 35 kg/m² at screening. Have blood pressure, pulse rate, blood and urine laboratory test results acceptable for the study. Have venous access sufficient to allow blood sampling. Have T2DM controlled with diet and exercise alone or are stable on metformin for at least 30 days.

The full record lists 8 inclusion and 9 exclusion criteria; among the exclusions: are currently participating in another clinical study; have a history of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction; have taken any glucose-lowering medications, other than metformin, including insulin, in the past 3 months before screening.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

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

The Insulin Glargine group and the comparison group ran side by side rather than switching.

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 2016-12-20 with completion listed for 2017-10-18.

It ran at 1 site in Germany.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration (time frame: Baseline through Day 31).

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; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin Glargine compound page, all human trials.