Efficacy and Safety of Once-Daily Insulin Degludec/Insulin Aspart versus Insulin Glargine (U100) for 52 Weeks in Insulin-Naïve Patients with Type 2 Diabetes: A Randomized Controlled Trial

What Was Tested

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

ClinicalTrials.gov: NCT01045707 [core]) and NCT01169766 [ext].

Who Took Part

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

In this open-label, parallel-group treat-to-target trial, participants were randomized (1:1) to receive IDegAsp OD (breakfast, n = 266) or IGlar OD (as per label, n = 264).

Participants then entered a 26-week extension phase (IDegAsp OD, n = 192; IGlar OD, n = 221).

How the Study Was Run

In design terms this was a randomized, open-label and parallel-group study.

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

Everyone knew when Insulin Glargine was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

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

The primary endpoint was change from baseline to Week 26 in HbA1c.

What Was Measured

PubMed files the paper under topics including Blood Glucose, Diabetes Mellitus, Type 2, Drug Combinations, Insulin Glargine, Insulin, Long-Acting and Safety.

What This Means in Plain Language

The paper is a randomized, open-label and parallel-group study of Insulin Glargine and Insulin Aspart.

Its findings take up roughly 6 sentences of the abstract and are left out here on purpose; the source paper is the place to read them.

The publication is from 2016 (PloS one), a journal based in United States.

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