Factors associated with nocturnal hypoglycaemia among patients with type 2 diabetes new to insulin therapy: experience with insulin lispro

What Was Tested

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

Who Took Part

The abstract describes 2 patients taking part.

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

A cohort of North American patients completed a health-related quality of life (HRQOL) questionnaire which included questions related to the Health Beliefs Model (HBM).

Three hundred and sixty-five type 2 diabetic patients were enrolled in the study, and 195 North American patients completed the HRQOL questionnaire.

How the Study Was Run

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

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

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

Running at several centres spread the Insulin Lispro study over different clinics and patient groups.

The Insulin Lispro group and the comparison group ran side by side rather than switching.

What Was Measured

The subject headings attached to it are Alcohol Drinking, Attitude to Health, Circadian Rhythm, Cohort Studies, Diabetes Mellitus, Type 2, Hypoglycemia and Hypoglycemic Agents.

What This Means in Plain Language

The paper is a randomized, open-label and multicenter study of Insulin Lispro in 2 patients.

With fewer than 40 people, it is a small study, so it is better read as an early signal for further research than as a settled answer.

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 2000 (Diabetes, obesity & metabolism), a journal based in England.

More context: the Insulin Lispro compound page, all human trials.