A Study to Evaluate the Effect of LY2189265 on the Speed at Which Food and Drink Leaves the Stomach in Patients With Type 2 Diabetes Mellitus

What Was Tested

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

The study will be participant-blind in Week 1, and participant- and investigator-blind from Week 2 through Week 5.

It had two arms (groups): Placebo (placebo comparator) and LY2189265 (experimental).

The registry classes the interventions as biological and drug.

Who Took Part

38 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Are males or females, diagnosed with Type 2 Diabetes Mellitus for greater than or equal to 3 months prior to screening. Have a body mass index (BMI) between 18.5 and 40.0 kilogram/square meter (kg/m²), inclusive. Have clinical laboratory test results within normal ranges as determined by the study doctor. Can provide enough blood in order to undergo the blood sampling required for the study. Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures.

The full record lists 10 inclusion and 20 exclusion criteria; among the exclusions: have previously been exposed to, or have known allergies to glucagon-like-peptide-1 (glp-1)-related compounds including ly2189265; have taken certain type 2 diabetes medications within 30 days prior to screening; have an abnormality in the electrocardiogram (ecg) performed at screening.

How the Study Was Run

It was run as a randomized, single-group and quadruple-blind study.

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

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

Everyone received the same intervention, so there was no separate comparison group inside the trial.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2010-09 with completion listed for 2011-07.

It ran at 1 site in United Kingdom.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 4 secondary outcomes, for example Area Under the Curve (AUC) of Metformin, Maximum Concentration (Cmax) of Metformin and Time to Maximum Concentration (Tmax) of Metformin.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Dulaglutide in 38 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.