A Study to Assess the Effect of Exenatide Treatment on Mean 24-Hour Heart Rate in Patients With Type 2 Diabetes

What Was Tested

In this phase 3 trial, researchers set out to test Exenatide.

This study will explore the effect of exenatide (given twice a day) versus placebo (given twice a day) treatment on change in mean 24-hour heart rate over a 12 week period of drug exposure in patients with type 2 diabetes.

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

This arm will receive placebo injection (volume equivalent to the exenatide injection in the experimental arm).

The registry classes the interventions as drug.

Who Took Part

54 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: Diagnosed with type 2 diabetes. Treated with metformin and/or a thiazolidinedione. Body Mass Index (BMI) \> 25 kg/m\^2 and \< 40 kg/m\^2.

The full record lists 4 inclusion and 8 exclusion criteria; among the exclusions: have previously received exenatide or glucagon-like peptide-1 analogs; receiving beta blockers; receiving treatment with a drug directly affecting gastrointestinal motility, including but not limited to reglan® (metoclopramide), propulsid® (cisapride), and chronic macrolide antibiotics.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

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

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 2007-09 with completion listed for 2008-04.

It ran at 6 sites in Netherlands (4) and Canada (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in Mean 24-hour Heart Rate From Baseline to Endpoint (time frame: 12 weeks).

It also tracked 5 secondary outcomes, for example Change in Daytime Heart Rate From Baseline to Endpoint, Change in Nighttime (2400-0600) Heart Rate From Baseline to Endpoint, Change in Mean 24 Hour Systolic Blood Pressure From Baseline to Endpoint, Change in Mean 24 Hour Diastolic Blood Pressure From Baseline to Endpoint and Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Exenatide in 54 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.