← Human Trials & Peer-Reviewed Studies

Efficacy and Safety of Degludec versus Glargine in Type 2 Diabetes

Plain-language guide to PMID 28605603 (2017): double-blind randomized controlled trial study of Insulin Glargine in 7637 patients.

Key Facts

PMID
28605603
Journal
The New England journal of medicine
Year
2017
Study type
Randomized Controlled Trial
Authors
Marso SP et al. (14 authors)
DOI
10.1056/NEJMoa1615692
Registered trial
NCT01959529

What This Study Did, in Plain Language

What Was Tested

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

Degludec is an ultralong-acting, once-daily basal insulin that is approved for use in adults, adolescents, and children with diabetes.

However, data are lacking on the cardiovascular safety of degludec.

Who Took Part

The abstract describes 7637 patients taking part.

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

The researchers randomly assigned 7637 patients with type 2 diabetes to receive either insulin degludec (3818 patients) or insulin glargine U100 (3819 patients) once daily between dinner and bedtime in a double-blind, treat-to-target, event-driven cardiovascular outcomes trial.

How the Study Was Run

The design is described as randomized, double-blind and open-label.

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

Blinding on both sides kept the patients and researchers unaware of who received Insulin Glargine.

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.

Adjudicated severe hypoglycemia, as defined by the American Diabetes Association, was the prespecified, multiplicity-adjusted secondary outcome.

What Was Measured

PubMed files the paper under topics including Blood Glucose, Cardiovascular Diseases, Diabetes Mellitus, Type 2, Hypoglycemia, Hypoglycemic Agents, Incidence and Insulin Glargine.

What This Means in Plain Language

The paper is a randomized, double-blind and open-label study of Insulin Glargine in 7637 patients.

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

Its findings take up roughly 8 sentences of the abstract and are left out here on purpose; the source paper is the place to read them.

The publication is from 2017 (The New England journal of medicine), a journal based in United States.

More context: the Insulin Glargine compound page.

Our Notes on the Compound

Insulin Glargine: A long-acting insulin analog given once daily; brands include Lantus, Toujeo, Basaglar and Semglee.

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.