Comparison of the effects on glycaemic control and β-cell function in newly diagnosed type 2 diabetes patients of treatment with exenatide, insulin or pioglitazone: a multicentre randomized parallel-group trial (the CONFIDENCE study)

What Was Tested

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

Progressive β-cell dysfunction hinders the maintenance of glycaemic control in type 2 diabetes, but comparative data on β-cell-protective therapies are lacking in the early stage of type 2 diabetes.

Who Took Part

According to the abstract, 416 patients were involved.

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

In this 48-week, multicentre, parallel-group study, 416 patients newly diagnosed with type 2 diabetes were randomly assigned 1 : 1 : 1 to receive exenatide, insulin or pioglitazone.

Secondary end-points included effects on weight, blood pressure, lipid profiles and β-cell function assessed by homeostasis model assessment, fasting proinsulin:insulin (PI/I), disposition index (DI) and acute insulin response (AIR).

How the Study Was Run

The design is described as randomized, multicenter and parallel-group.

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.

Running at several centres spread the Exenatide study over different clinics and patient groups.

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

The primary end-point was the change in glycosylated haemoglobin (HbA1c) from baseline.

What Was Measured

The subject headings attached to it are Blood Glucose, Confidence Intervals, Diabetes Mellitus, Type 2, Exenatide, Hospitals, University, Hypoglycemic Agents and Insulin.

Author keywords: pioglitazone and β-cell function.

What This Means in Plain Language

The paper is a randomized, multicenter and parallel-group study of Exenatide in 416 patients.

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

Results are reported in around 4 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2015 (Journal of internal medicine), a journal based in England.

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