A Study of the Effect of Dulaglutide on the Action of Warfarin in Healthy Participants

What Was Tested

This registered phase 1 trial tested Dulaglutide.

The purpose of this study is to determine if dulaglutide (LY2189265) affects how warfarin works.

The study involves two different treatments (Treatment 1: warfarin; Treatment 2: dulaglutide + warfarin) separated by a minimum washout period of 24 days.

It had two arms (groups): Warfarin first, then Dulaglutide + Warfarin (experimental) and Dulaglutide + Warfarin first, then Warfarin (experimental).

The registry classes the interventions as biological and drug.

Who Took Part

28 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: Condom with spermicidal agent. Male participant sterilization. True abstinence (which is in line with the participant's usual lifestyle choice; withdrawal or calendar methods are not considered acceptable). Have a body mass index (BMI) of 18.5 to 32.0 kilograms per meter squared (kg/m\^2), inclusive, at screening. Have venous access sufficient to allow for blood sampling.

The full record lists 10 inclusion and 31 exclusion criteria; among the exclusions: have known allergies to glucagon-like-peptide 1 (glp-1)-related compounds including dulaglutide or to warfarin, related compounds, or any components of either formulation; have a personal or family history of polycystic kidney disease or protein c or s deficiency; have a history of or plan to undergo major surgery in the last 3 months prior to screening.

How the Study Was Run

Design: randomized, crossover and open-label.

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

Each person switched between Dulaglutide and the comparison at some point, usually with a gap in between.

Being open-label, the Dulaglutide study did not mask who received what.

It started in 2011-09 with completion listed for 2011-12.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Dulaglutide in 28 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 Dulaglutide compound page, all human trials.