Durability of insulin degludec plus liraglutide versus insulin glargine U100 as initial injectable therapy in type 2 diabetes (DUAL VIII): a multicentre, open-label, phase 3b, randomised controlled trial

What Was Tested

The paper reports a study of Insulin Glargine and Liraglutide, published as a randomized controlled trial.

Who Took Part

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

Patients were randomly assigned 1:1, with a simple sequential allocation randomisation schedule (block size of four), to IDegLira or IGlar U100, each treatment being an add-on to existing therapy.

Patients and all other investigators were not masked.

How the Study Was Run

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

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

Being open-label, the Insulin Glargine study did not mask who received what.

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

The internal safety committee, the independent external committee, and the personnel involved in defining the analysis sets were masked until the database was released for statistical analysis.

Both treatments were given once daily at any time of day and it was recommended that the time of day remained the same throughout the trial.

Once patients met this criterion, the trial product was permanently discontinued and patients were not withdrawn from trial but rather remained on follow-up for the entire treatment and follow-up period.

The primary analysis was in the intention-to-treat population.

This study is registered with ClinicalTrials.gov, number NCT02501161.

What Was Measured

PubMed files the paper under topics including Diabetes Mellitus, Type 2, Drug Combinations, Hypoglycemic Agents, Insulin Glargine, Insulin, Long-Acting and Liraglutide.

What This Means in Plain Language

The paper is a randomized, open-label and multicenter study of Insulin Glargine and Liraglutide.

Its findings take up roughly 7 sentences of the abstract and are left out here on purpose; the source paper is the place to read them.

The publication is from 2019 (The lancet. Diabetes & endocrinology), a journal based in England.

More context: the Insulin Glargine compound page and the Liraglutide compound page.