Reduction in intrasubject variability in the pharmacokinetic response to insulin after subcutaneous co-administration with recombinant human hyaluronidase in healthy volunteers

What Was Tested

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

Who Took Part

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

Healthy adult volunteers (18-55 years old) were enrolled in this phase 1, randomized, double-blind, crossover study.

Subjects were administered two injections, each on a separate occasion, of three treatments during six euglycemic clamps.

How the Study Was Run

In design terms this was a randomized, double-blind and crossover 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.

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

Serum immunoreactive insulin levels, blood glucose concentration, and glucose infusion rate determinations were made at baseline and for approximately 8 h after study drug administration.

Intrasubject variability was assessed using a general linear mixed model with a fixed effect for treatment using a compound symmetric covariance matrix.

What Was Measured

Topics PubMed links to this paper include Blood Glucose, C-Peptide, Drug Synergism, Glucose Clamp Technique, Hyaluronoglucosaminidase, Insulin Lispro and Recombinant Proteins.

What This Means in Plain Language

The paper is a randomized, double-blind and crossover study of Insulin Lispro.

The abstract goes on to report its results in about 4 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2011 (Diabetes technology & therapeutics), a journal based in United States.

More context: the Insulin Lispro compound page.