Effect of LY2189265 on Insulin Secretion in Response to Intravenous Glucose

What Was Tested

In this phase 1 trial, researchers set out to test Insulin (regular human) and Glucagon.

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

The registry classes the interventions as biological and drug.

Who Took Part

Enrollment: 32 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.

The full record lists 17 inclusion and 27 exclusion criteria; among the exclusions: known allergies to glucagon-like peptide 1 (glp-1) related compounds; have previously completed or withdrawn from this study or any other study in the last year investigating glucagon-like peptides or incretin mimetics including exenatide (byetta®); regular use of known drugs of abuse and/or positive findings on urinary drug screening, other than findings consistent with medication prescribed by the participant's physician(s).

How the Study Was Run

It was run as a randomized, crossover and triple-blind study.

Random assignment meant chance, not the researchers, decided who got Insulin (regular human) and who got the comparison, which limits bias.

In the crossover set-up each of the participants took both Insulin (regular human) and the comparison in turn, acting as their own control.

As a double-blind Insulin (regular human) study, the assignments were hidden from both participants and investigators until the end.

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

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

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Maximum Insulin Concentration (Cmax) - First Phase Response (time frame: 0-10 minutes after dextrose bolus on Day 3 postdose). Area Under the Insulin Concentration-time Curve (AUC) - First Phase Response (time frame: 0-10 minutes after dextrose bolus on Day 3 postdose). Maximum Insulin Concentration (Cmax) - Second Phase Response (time frame: 10-180 minutes after dextrose bolus on Day 3 postdose).

It also tracked 1 secondary outcome, for example Insulin Maximum Concentration (Cmax).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin (regular human) and Glucagon in 32 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 Insulin (regular human) compound page and the Glucagon compound page, all human trials.