A Study to Compare Methodologies for Assessing Glucose-Dependent Insulin Secretion (0000-104)(COMPLETED)

What Was Tested

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

This study will compare graded glucose infusion (GGI) to the hyperglycemic clamp (HGC) for assessment of glucose-dependent insulin secretion (GDIS) using exenatide as a probe.

It had three arms (groups): 1 (active comparator), 2 (active comparator) and 3 (placebo comparator).

Placebo.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 27 actual participants took part.

It was open to men only aged from 18 years up to 45 years.

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

Examples of who could join: Subject has a Body Mass Index (BMI) of less than or equal to 26 kg/m2 at screening. Subject is judged to be in good health. Subject has been a nonsmoker for at least 3 months. Subject is willing to avoid strenuous physical activity for the duration of the study.

The full record lists 4 inclusion and 9 exclusion criteria; among the exclusions: subject has a history of high blood pressure requiring treatment; subject has a history of diabetes or a family history of diabetes mellitus; subject is unable to discontinue all prescription and non-prescription drugs for duration of study.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Exenatide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2008-09 with completion listed for 2009-02.

Its stated primary purpose is diagnostic.

What Was Measured

The main thing measured (primary outcome): Change From Baseline in Insulin Secretion Rate (ISR) Normalized to Ambient Plasma Glucose. Change From Baseline in C-peptide Concentration (time frame: Pre and Post glucose infusion). Change From Baseline in Insulin Concentration (time frame: Pre and Post glucose infusion).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Exenatide in 27 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 Exenatide compound page, all human trials.