Effect of long-term exposure to insulin lispro on the induction of antibody response in patients with type 1 or type 2 diabetes

What Was Tested

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

To determine the long-term effects of insulin lispro on inducing lispro-specific, insulin-specific, and cross-reactive (reactive with both insulin lispro and human insulin) antibodies.

A multinational, multicenter combination of controlled and noncontrolled, open-label studies of 4.5 years' duration was designed to evaluate the long-term immunologic profile of subcutaneously administered insulin lispro.

Who Took Part

The abstract describes 1,221 patients taking part.

The age groups tagged for this paper are children, teenagers, adults, middle-aged adults, older adults and people over 80, both men and women.

A total of 1,221 patients (men and women; 12-81 years of age) with type 1 or type 2 diabetes were enrolled.

How the Study Was Run

The design is described as open-label, crossover and multicenter.

Everyone knew when Insulin Lispro was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Each person switched between Insulin Lispro and the comparison at some point, usually with a gap in between.

More than one site took part, so the patients came from several places.

Circulating anti-insulin antibodies were measured using radioimmunoassays.

What Was Measured

Topics PubMed links to this paper include Cross Reactions, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Drug Hypersensitivity, Hypoglycemic Agents, Incidence and Insulin.

What This Means in Plain Language

The paper is an open-label, crossover and multicenter study of Insulin Lispro in 1,221 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 11 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2003 (Diabetes care), a journal based in United States.

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