DEVOTE 3: temporal relationships between severe hypoglycaemia, cardiovascular outcomes and mortality

What Was Tested

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

The double-blind Trial Comparing Cardiovascular Safety of Insulin Degludec vs Insulin Glargine in Patients with Type 2 Diabetes at High Risk of Cardiovascular Events (DEVOTE) assessed the cardiovascular safety of insulin degludec.

The incidence and rates of adjudicated severe hypoglycaemia, and all-cause mortality were also determined.

This paper reports a secondary analysis investigating associations of severe hypoglycaemia with cardiovascular outcomes and mortality.

Who Took Part

PubMed tags the participants as both men and women.

An investigation with interaction terms indicated that the effect of severe hypoglycaemia on the risk of MACE and all-cause mortality were the same for both treatment arms, and so the temporal association for severe hypoglycaemia with subsequent MACE and all-cause mortality is reported for the pooled population.

How the Study Was Run

In design terms this was a randomized and double-blind study.

Because people in this Insulin Glargine study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

As a double-blind Insulin Glargine study, the assignments were hidden from both participants and investigators until the end.

Adjudicated severe hypoglycaemia was the pre-specified secondary outcome.

What Was Measured

The subject headings attached to it are Diabetes Mellitus, Type 2, Glycated Hemoglobin, Hypoglycemia, Hypoglycemic Agents, Insulin Glargine and Insulin, Long-Acting.

The authors tagged it with the keywords Hypoglycaemia, Insulin therapy and Macrovascular disease.

What This Means in Plain Language

The paper is a randomized and double-blind study of Insulin Glargine.

Results are reported in around 7 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2018 (Diabetologia), a journal based in Germany.

More context: the Insulin Glargine compound page.