Use of twice-daily exenatide in Basal insulin-treated patients with type 2 diabetes: a randomized, controlled trial

What Was Tested

The paper reports a study of Exenatide, published as a randomized controlled trial.

Insulin replacement in diabetes often requires prandial intervention to reach hemoglobin A₁(c) (HbA₁(c)) targets.

The study was of short duration.

Who Took Part

The age groups tagged for this paper are middle-aged adults and older adults, both men and women.

Participants, investigators, and personnel conducting the study were masked to treatment assignments.

How the Study Was Run

The design is described as randomized, double-blind, placebo-controlled and parallel-group.

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

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

Some participants received a placebo instead of Exenatide, giving a reference point.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Parallel, randomized, placebo-controlled trial, blocked and stratified by HbA₁(c) level at site, performed from October 2008 to January 2010.

59 centers in 5 countries.

The primary outcome was change in HbA₁(c) level.

What Was Measured

There were slight imbalances between groups at baseline in terms of sex, use of concomitant glucose-lowering medications, and HbA₁(c) levels, and more exenatide recipients than placebo recipients withdrew because of adverse events.

PubMed files the paper under topics including Diabetes Mellitus, Type 2, Exenatide, Glycated Hemoglobin, Hypoglycemic Agents, Insulin, Insulin Glargine and Insulin, Long-Acting.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Exenatide.

Results are reported in around 8 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2011 (Annals of internal medicine), a journal based in United States.

More context: the Exenatide compound page, all human trials.