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Exenatide once weekly plus dapagliflozin once daily versus exenatide or dapagliflozin alone in patients with type 2 diabetes inadequately controlled with metformin monotherapy (DURATION-8): a 28 week, multicentre, double-blind, phase 3, randomised controlled trial

Plain-language guide to PMID 27651331 (2016): double-blind randomized controlled trial study of Exenatide.

Key Facts

PMID
27651331
Journal
The lancet. Diabetes & endocrinology
Year
2016
Study type
Randomized Controlled Trial
Authors
Frías JP et al. (7 authors)
DOI
10.1016/S2213-8587(16)30267-4

What This Study Did, in Plain Language

What Was Tested

This randomized controlled trial paper looks at Exenatide.

Who Took Part

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

How the Study Was Run

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

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.

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

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

More than one site took part, so the participants came from several places.

DURATION-8 was a 28 week, multicentre, double-blind, randomised, active-controlled phase 3 trial done at 109 sites in six countries.

The primary endpoint was change in HbA1c from baseline to week 28.

Analyses were by intention to treat.

This trial is registered with ClinicalTrials.gov, number NCT02229396.

What Was Measured

PubMed files the paper under topics including Benzhydryl Compounds, Diabetes Mellitus, Type 2, Exenatide, Glucosides, Hypoglycemic Agents, Metformin and Peptides.

What This Means in Plain Language

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

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 2016 (The lancet. Diabetes & endocrinology), a journal based in England.

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

Our Notes on the Compound

Exenatide: A 39-amino-acid GLP-1 receptor agonist first identified in Gila monster venom; sold as Byetta and Bydureon for type 2 diabetes.

Related Pages

Source: PubMed record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.