Metabolic effects of two years of exenatide treatment on diabetes, obesity, and hepatic biomarkers in patients with type 2 diabetes: an interim analysis of data from the open-label, uncontrolled extension of three double-blind, placebo-controlled trials

What Was Tested

This randomized controlled trial paper looks at Exenatide.

The purpose of this study was to examine the metabolic effects of 2 years of exenatide treatment in patients with T2DM.

Who Took Part

PubMed indexes the participants as middle-aged adults and older adults, both men and women.

Some patients were followed up in open-label extensions to provide 'real-world' exenatide clinical experience.

For this interim analysis, data were pooled from patients who completed 1 of three 30-week, multicenter, double-blind, placebo-controlled trials and their open-label extensions.

How the Study Was Run

The researchers set it up as a randomized, double-blind, open-label, placebo-controlled and multicenter study.

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

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

Everyone knew when Exenatide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

The comparison arm used a placebo, so changes seen with Exenatide could be set against what happens without it.

The methods mention a period of 30 weeks.

In the initial trials, subjects were randomized to BID 5-microg exenatide, 10-microg exenatide, or placebo for 30 weeks.

All subjects who enrolled in the extension phase then received 5-pg exenatide BID for 4 weeks, followed by open-label treatment with 10-pg exenatide BID.

Subjects continued their existing metformin and/or sulfonylurea regimens.

Analyses were conducted on data from all subjects who had the opportunity to achieve 2 years of exenatide exposure, irrespective of their treatment arm in the 30-week placebo-controlled trials.

What Was Measured

Topics PubMed links to this paper include Alanine Transaminase, Aspartate Aminotransferases, Biomarkers, Blood Pressure, Diabetes Mellitus, Type 2, Exenatide and Glycated Hemoglobin.

What This Means in Plain Language

The paper is a randomized, double-blind and open-label study of Exenatide over 30 weeks.

The abstract goes on to report its results in about 11 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2007 (Clinical therapeutics), a journal based in United States.

More context: the Exenatide compound page.