Effects of multiple daily injection therapy with Humalog mixtures versus separately injected insulin lispro and NPH insulin in adults with type I diabetes mellitus

What Was Tested

Researchers studied Insulin Lispro and NPH Insulin (isophane) in this randomized controlled trial publication.

The H/M formulation was given before meals and was compared with treatment with preprandial LP + NPH (LP + N) in patients with type 1 diabetes mellitus (DM).

Why It Was Studied

When used in a similar fashion, premixed, fixed-ratio insulin preparations containing LP and NPL (an LP-based intermediate-acting insulin) may provide the basis for an optimized basal-bolus insulin regimen.

Who Took Part

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

Patients were randomly assigned to 1 of 2 treatment sequences: LP self-mixed with NPH before meals plus NPH alone at bedtime for 8 weeks (LP + N) followed by preprandial H or M, plus NPH alone at bedtime for 8 weeks (H/M), or the opposite sequence.

How the Study Was Run

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

The participants 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 participants and staff both knew the treatment.

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 participants came from several places.

The timeline in the abstract includes 8 weeks.

This multicenter, randomized, open-label, 2-period crossover study was conducted at 4 centers in Italy and 1 center in France.

The primary outcome measure was the late postprandial BG value, calculated as the mean of the combined prelunch (late postbreakfast), predinner (late postlunch), and bedtime (late postdinner) values.

What Was Measured

The subject headings attached to it are Diabetes Mellitus, Type 1, Drug Combinations, Hypoglycemia, Hypoglycemic Agents, Insulin, Insulin Lispro and Insulin, Isophane.

What This Means in Plain Language

The paper is a randomized, open-label and crossover study of Insulin Lispro and NPH Insulin (isophane) over 8 weeks.

Its findings take up roughly 5 sentences of the abstract and are left out here on purpose; the source paper is the place to read them.

The publication is from 2004 (Clinical therapeutics), a journal based in United States.

More context: the Insulin Lispro compound page and the NPH Insulin (isophane) compound page, all human trials.