Mealtime treatment with insulin analog improves postprandial hyperglycemia and hypoglycemia in patients with non-insulin-dependent diabetes mellitus. Multicenter Insulin Lispro Study Group

What Was Tested

This randomized controlled trial paper looks at Insulin Lispro.

To compare insulin lispro and human regular insulin in the mealtime treatment of patients with NIDDM.

Why It Was Studied

Insulin lispro is an insulin analog that was recently developed particularly for a mealtime therapy.

It has a fast absorption rate and short duration of action.

Who Took Part

The study group was 722 patients.

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

A 6-month, randomized, multinational (16 countries), multicenter (80 sites) clinical trial with an open-label, crossover design was performed in 722 patients with NIDDM.

How the Study Was Run

The researchers set it up as a randomized, open-label, crossover and multicenter study.

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

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

In the crossover set-up each of the patients took both Insulin Lispro and the comparison in turn, acting as their own control.

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

Insulin lispro was injected immediately before and human regular insulin 30 to 45 minutes before the meal.

What Was Measured

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

What This Means in Plain Language

The paper is a randomized, open-label and crossover study of Insulin Lispro in 722 patients.

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

The abstract goes on to report its results in about 7 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 1997 (Archives of internal medicine), a journal based in United States.

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