Can Exenatide Prevent Increase in EGP in Response to Dapagliflozin-induced Increase in Glucosuria

What Was Tested

The trial (phase 4) is built around Exenatide.

Research Design/Plan: After screening, each subject will receive 1 measurements of Endogenous Glucose Production \[EGP\] with prime-continuous Infusion of 3-3H-glucose.

After completing the EGP measurement each subject will receive a Double Tracer Oral Glucose Tolerance Test \[OGTT\].

Medical history will be obtained, physical exam performed, and pregnancy test performed.

It had four arms (groups): Placebo (placebo comparator), Exenatide (active comparator), Dapagliflozin (active comparator) and Exenatide and Dapagliflozin (active comparator).

The registry classes the interventions as drug.

More on the Plan

Eligible subjects will receive a measurement of endogenous glucose production (EGP) with a prime-continuous infusion of 3-3H-glucose.

The EGP measurement will be performed in the morning after a 10-12 hour overnight fast and will last 8 hours (from 6 AM to 2 PM).

Following the test medication at 9 AM, blood samples will be drawn every 15 minutes for an additional 5 hours and plasma glucose, insulin, C-peptide, glucagon, cortisol, growth hormone, and catecholamine concentrations and glucose specific activity will be measured.

Medical history \& physical exam will be performed.

Who Took Part

The registry lists 107 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: proliferative diabetic retinopathy; medication: subjects taking drugs known to affect glucose metabolism (other than metformin and sulfonylurea).

How the Study Was Run

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

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

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

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

It started in 2018-02-28 with completion listed for 2022-03-31.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Change in EGP From Baseline to Post-oral Glucose Load (time frame: From baseline [-35 to 0min] to the last hour post-glucose load [240-300 minutes]).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Exenatide in 107 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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