Effect of Exenatide on 24-Hour Blood Glucose Profile Compared With Placebo in Patients With Type 2 Diabetes

What Was Tested

This registered phase 2 trial tested Exenatide.

The purpose of this study is to test the hypothesis that in patients with type 2 diabetes, the addition of exenatide will result in lower time-averaged serum glucose during a 24-hour period, compared with placebo.

It had two arms (groups): Exenatide (experimental) and Placebo (placebo comparator).

Exenatide and the subject's current oral antidiabetic agent regimen.

Placebo and the subject's current oral antidiabetic agent regimen.

The registry classes the interventions as drug.

Who Took Part

The registry lists 30 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Subject has a body mass index (BMI) \>25 kg/m\^2 and \<50 kg/m\^2.

The full record lists 3 inclusion and 2 exclusion criteria; among the exclusions: subject has received exenatide, glp-1 analogs, dpp-iv inhibitors, or has participated in this study previously.

How the Study Was Run

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

Because people in this Exenatide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Exenatide group and the comparison group ran side by side rather than switching.

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

Those kept unaware of assignments: participant and investigator.

It started in 2005-10 with completion listed for 2007-06.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Time-averaged serum glucose during a 24-hour period (time frame: Every half-hour to hour for 24 hours).

It also tracked 1 secondary outcome, for example To compare the effects of exenatide and placebo on serum glucose.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Exenatide in 30 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.