Comparative efficacy of preprandial or postprandial Humalog Mix75/25 versus glyburide in patients 60 to 80 years of age with type 2 diabetes mellitus

What Was Tested

This randomized controlled trial paper looks at Insulin Lispro.

The purpose of this study was to compare glycemic control and hypoglycemia rates with Mix75/25 versus glyburide, and with preprandial versus postprandial Mix75/25, in patients aged 60 to 80 years with type 2 diabetes mellitus and persistent hyperglycemia on sulfonylurea therapy.

Who Took Part

The abstract describes 25, patients taking part.

PubMed indexes the participants as middle-aged adults, older adults and people over 80, both men and women.

How the Study Was Run

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

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

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

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

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

The Mix75/25 group was randomly subdivided into preprandial (immediately before breakfast and dinner) and postprandial (within 15 minutes after the start of breakfast and dinner) injection subgroups.

The primary outcomes were glycemic control and rate of hypoglycemia.

What Was Measured

The subject headings attached to it are Blood Glucose, Diabetes Mellitus, Type 2, Glyburide, Glycated Hemoglobin, Hypoglycemia, Hypoglycemic Agents and Insulin.

What This Means in Plain Language

The paper is a randomized, double-blind and open-label study of Insulin Lispro in 25, 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.

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 2002 (Clinical therapeutics), a journal based in United States.

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