Interim analysis of the effects of exenatide treatment on A1C, weight and cardiovascular risk factors over 82 weeks in 314 overweight patients with type 2 diabetes

What Was Tested

This randomized controlled trial paper looks at Exenatide.

This analysis examined the effects of exenatide on glycaemic control and weight over an 82-week period in patients with DM2 unable to achieve adequate glycaemic control with sulphonylurea (SU) and/or metformin (MET).

Who Took Part

The study group was 314 patients.

By PubMed's age tags, the people studied were teenagers, adults, middle-aged adults and older adults, both men and women.

This interim analysis is of 314 patients who received exenatide in the 30-week placebo-controlled trials and subsequently in 52 weeks of open-label uncontrolled extension studies for 82 weeks of exenatide in total.

Patients continued their SU and/or MET regimens throughout.

How the Study Was Run

In design terms this was a randomized, double-blind, open-label and placebo-controlled study.

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

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

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.

A placebo (an inactive look-alike) gave the Exenatide group a baseline to be compared against.

The methods mention a period of 82 weeks.

What Was Measured

Topics PubMed links to this paper include Blood Glucose, Blood Pressure, Cardiovascular Diseases, Diabetes Mellitus, Type 2, Diabetic Angiopathies, Exenatide and Glycated Hemoglobin.

What This Means in Plain Language

The paper is a randomized, double-blind and open-label study of Exenatide in 314 patients over 82 weeks.

With several hundred people or more, it is a fairly large study for this kind of research.

Results are reported in around 7 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2006 (Diabetes, obesity & metabolism), a journal based in England.

More context: the Exenatide compound page.