A Study by Scintigraphy to Evaluate the Effect of Exenatide on Gastric Emptying in Subjects With Type 2 Diabetes

What Was Tested

The trial (phase 1) is built around Exenatide.

As exenatide slows the rate at which materials leave the stomach, it is likely to alter the rate of intestinal absorption of oral drugs when administered within a certain timeframe relative to exenatide.

This study will also evaluate the relationship between blood levels of exenatide and parameters measuring rate of stomach emptying.

It had three arms (groups): Sequence 1 (experimental), Sequence 2 (experimental) and Sequence 3 (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 17 actual participants took part.

It was open to people of any sex aged from 25 years up to 75 years.

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

Examples of who could join: Subjects with at least 1 year history of type 2 diabetes mellitus. Between the body mass index (BMI) of 19 kg/m2 and 40 kg/m2, inclusive.

The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: persons who have previously completed or withdrawn from this study or any other study investigating exenatide; subjects who have used insulin for more than 4 weeks within 3 months prior to screening.

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.

Only one side, usually the participants, was kept unaware of whether Exenatide was given.

Those kept unaware of assignments: participant.

It started in 2005-01 with completion listed for 2005-06.

It ran at 1 site in United Kingdom.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): To detect the mean difference in half gastric emptying time for a solid meal between any treatment and placebo (time frame: up to 12 hours post meal consumption).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Exenatide in 17 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.