A Study of LY3493269 in Participants With Type 2 Diabetes

What Was Tested

This registered phase 1 trial tested Dulaglutide.

The main purpose of this study is to determine the side effects related to LY3493269 in participants with type 2 diabetes.

Blood tests will be performed to check concentrations of LY3493269 in the bloodstream.

Each enrolled participant will receive LY3493269, dulaglutide, or placebo.

The registry classes the interventions as drug.

Who Took Part

The registry lists 56 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Are male or female not of childbearing potential. Have a body mass index of 23 to 50 kilograms per square meter (kg/m²), inclusive, at screening. Have not modified their diet or adopted any nutritional lifestyle modification in the 3 months prior to screening.

The full record lists 7 inclusion and 8 exclusion criteria; among the exclusions: have type 1 diabetes mellitus or latent autoimmune diabetes in adults; have uncontrolled diabetes, defined as an episode of ketoacidosis or hyperosmolar state requiring hospitalization in the 6 months prior to screening; have a history of proliferative diabetic retinopathy, diabetic maculopathy, or severe nonproliferative diabetic retinopathy that requires acute treatment.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

The participants were allocated by chance, so the Dulaglutide group and the comparison group should start out alike.

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

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

Those kept unaware of assignments: participant and investigator.

It started in 2020-08-25 with completion listed for 2021-03-09.

It ran at 3 sites in United States (3).

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Number of Participants With One or More Treatment-Emergent Adverse Event(s) (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration (time frame: Baseline through final follow-up at Day 57).

It also tracked 3 secondary outcomes, for example PK: Maximum Observed Drug Concentration (Cmax) of LY3493269.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Dulaglutide in 56 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Dulaglutide compound page, all human trials.