A Study to Compare the Concentrations of LY2189265 After Different Methods of Administration to Healthy Volunteers.

What Was Tested

This registered phase 1 trial tested Dulaglutide.

LY2189265 is an investigational drug being developed for the treatment of type 2 diabetes mellitus.

This study will compare the concentrations of LY2189265 using different methods of administration: subcutaneous (or SC- an injection just under the skin), intravenous (or IV - into a vein in the arm) and intramuscular (IM - into the muscle of the left thigh).

The purpose of this study is to look at how much of the drug gets into the blood stream and how long it takes the body to get rid of it when given by the methods above.

It had three arms (groups): Part A: LY2189265 intravenous (experimental), Part B: LY2189265 subcutaneous, intravenous (experimental) and Part C: LY2189265 subcutaneous, intramuscular (experimental).

The registry classes the interventions as biological.

Who Took Part

Enrollment: 30 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Are overtly healthy males or females, as determined by medical history and physical examination. Have a body mass index (BMI) of between 23.0 and 35.0 kilogram/square meter (kg/m²), inclusive. Have normal sitting blood pressure and pulse rate as determined by the investigator, or with changes compatible with their age. Have venous access sufficient to allow for blood sampling and/or IV administration of investigational product as per the protocol. 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 17 exclusion criteria; among the exclusions: are women of child bearing potential; have known allergies to glucagon-like peptide-1 (glp-1)-related compounds including ly2189265; are persons who have previously completed or withdrawn from this study or any other study investigating ly2189265.

How the Study Was Run

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

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

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

Everyone knew when Dulaglutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2011-02 with completion listed for 2011-08.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Maximum Concentration (Cmax) of LY2189265: Subcutaneous (SC) to Intravenous (IV) (time frame: Predose up to 336 hours postdose).

It also tracked 2 secondary outcomes, for example Area Under the Concentration Time Curve (AUC) of LY2189265: Intramuscular (IM) to Subcutaneous (SC) and )Maximum Concentration (Cmax) of LY2189265: Intramuscular (IM) to Subcutaneous (SC).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Dulaglutide in 30 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.