Insulin degludec, an ultra-long-acting basal insulin, once a day or three times a week versus insulin glargine once a day in patients with type 2 diabetes: a 16-week, randomised, open-label, phase 2 trial

What Was Tested

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

Insulin degludec is a new basal insulin that forms soluble multihexamer assemblies after subcutaneous injection, resulting in an ultra-long action profile.

Who Took Part

The age groups tagged for this paper are teenagers, young adults, adults, middle-aged adults and older adults, both men and women.

Participants were randomly allocated in a 1:1:1:1 ratio by computer-generated block randomisation to receive insulin degludec either once a day or three times a week or insulin glargine once a day, all in combination with metformin.

The primary outcome was HbA(1C) after 16 weeks of treatment.

How the Study Was Run

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

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

Nothing was hidden in this open-label Insulin Glargine study: the participants and staff both knew the treatment.

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

A time span of 16 weeks appears in the methods.

Investigators were masked to data until database release.

Analyses were done by intention to treat.

This trial is registered with ClinicalTrials.gov, number NCT00611884.

What Was Measured

Topics PubMed links to this paper include Blood Glucose, Diabetes Mellitus, Type 2, Glycated Hemoglobin, Hypoglycemic Agents, Insulin, Insulin Glargine and Insulin, Long-Acting.

What This Means in Plain Language

The paper is a randomized, open-label and parallel-group study of Insulin Glargine over 16 weeks.

The abstract goes on to report its results in about 5 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2011 (Lancet (London, England)), a journal based in England.

More context: the Insulin Glargine compound page.