Pharmacogenomics of GLP1 Receptor Agonists

What Was Tested

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

Healthy volunteers were recruited from the Old Order Amish population in Lancaster County, Pennsylvania.

After providing informed consent, research participants were screened for eligibility.

The clinical trial was designed as a randomized crossover study in which participants underwent two frequently sampled intravenous glucose tolerance tests - one after receiving a subcutaneous injection of saline and one after receiving a subcutaneous injection of rapid-acting exenatide (BYETTA).

It had two arms (groups): Exenatide followed by saline (other) and Saline followed by exenatide (other).

Participants were randomized to receive exenatide 15 min before the first frequently sampled iv glucose tolerance test and saline 15 min before the second frequently sampled iv glucose tolerance test.

Participants were randomized to receive saline15 min before the first frequently sampled iv glucose tolerance test and exenatide15 min before the second frequently sampled iv glucose tolerance test.

The registry classes the interventions as drug.

More on the Plan

The clinical trial was designed as a randomized crossover study in which participants underwent two frequently sampled intravenous glucose tolerance tests (FSIGT) - one after receiving a subcutaneous injection of saline and one after receiving a subcutaneous injection of rapid-acting exenatide (BYETTA).

Based on data obtained from the FSIGT, participants' response to exenatide was assessed -- specifically, the effect of exenatide to enhance insulin secretion and accelerate metabolism of glucose.

Who Took Part

63 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: Member of the Old Order Amish community in Lancaster County, Pennsylvania. BMI: 18-40 kg/sq.m.

The full record lists 2 inclusion and 11 exclusion criteria; among the exclusions: known allergy to exenatide; seizure disorder; pregnant by self-report or known pregnancy within 3 months of the start of study.

How the Study Was Run

The set-up was randomized, crossover and single-blind.

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

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

In this single-blind Exenatide study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2016-06-01 with completion listed for 2018-11-30.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Exenatide Effect on First Phase Insulin Secretion (time frame: 0-10 minutes). Exenatide Effect on Glucose Disappearance Rate (time frame: 25-50 minutes).

It also tracked 6 secondary outcomes, for example Glucose Disappearance Rate (Exenatide), Glucose Disappearance Rate (Placebo), First Phase Insulin Secretion (Exenatide), First Phase Insulin Secretion (Placebo), Drug Effect on First-Phase Insulin Secretion (Genotype-specific) and Exenatide's Effect on the Rate of Glucose-disappearance (Genotype Specific).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Exenatide in 63 people.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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