Evaluating Exenatide for the Treatment of Postprandial Hyperinsulinemic Hypoglycemia

What Was Tested

The trial (phase 1) is built around Exenatide.

It had three arms (groups): one (active comparator), one (active comparator) and one (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Unfortunately, among the potential complications is hyperinsulinemic hypoglycemia.

The underlying pathophysiology of hyperinsulinemic hypoglycemia likely involves a mismatch in the amount of insulin secreted in response to mealtime carbohydrate absorption.

It has been observed that the ingestion of a high carbohydrate load often leads to a modest rise in post-prandial glucose levels followed by an inappropriately exaggerated insulin release among individuals with this condition.

Low carbohydrate diet sometimes provides full or partial relief of the symptoms.

Who Took Part

11 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

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

The full record lists 2 inclusion and 8 exclusion criteria; among the exclusions: chronic or acute diseases of the liver; chronic or acute diseases of the kidneys; known malignancies and must not have a family history of medullary thyroid cancer.

How the Study Was Run

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

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

In the crossover set-up each of the participants took both Exenatide and the comparison in turn, acting as their own control.

Blinding on both sides kept the participants and researchers unaware of who received Exenatide.

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

It started in 2016-02 with completion listed for 2019-07-22.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Glucose area under the curve (AUC) following treatment for each 4-hour test period (time frame: During the 4-hour test period). Presence of hypoglycemia (time frame: 15, 30, 45, 60, 90, 120, 180 and 240 minutes).

It also tracked 3 secondary outcomes, for example Minimum post-prandial blood sugar level (mg/dL), Change in post-prandial blood glucose from 0min to 120min and Change in post-prandial Insulin levels (mcg/mL).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Exenatide in 11 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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