Phase II Pharmacokinetics Study of Humalog and Humulin-R With and Without rHuPH20 in Type 1 Diabetes Mellitus

What Was Tested

This registered phase 2 trial tested Insulin Lispro.

Humalog and Humulin-R (recombinant human insulin) are Food and Drug Administration (FDA) approved medications for the treatment of diabetes mellitus.

Recombinant human hyaluronidase PH20 (rHuPH20) is approved by the FDA for use as an aid in the absorption and dispersion of other injectable drugs.

It had 1 arm (groups): First Humalog+PH20, then Humalog, Humulin-R+PH20, Humulin-R (experimental).

The registry classes the interventions as drug and other.

More on the Plan

Participants received all 4 interventions in the same order.

Who Took Part

22 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Participants with Type 1 diabetes mellitus treated with insulin for greater than or equal to 12 months. Body mass index (BMI) 18.0 to 29.0 kilograms per meter squared (kg/m\^2), inclusive. Fasting C-peptide less than 0.6 nanograms per milliliter (ng/mL).

The full record lists 7 inclusion and 16 exclusion criteria; among the exclusions: known or suspected allergy to any component of any of the study drugs in this trial; previous enrollment in this trial; A participant who has proliferative retinopathy or maculopathy, and/or severe neuropathy, in particular autonomic neuropathy, as judged by the Investigator.

How the Study Was Run

It was run as a crossover and single-blind study.

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

Only one side, usually the participants, was kept unaware of whether Insulin Lispro was given.

Those kept unaware of assignments: participant.

It started in 2008-10 with completion listed for 2009-03.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Area Under the Insulin Concentration-time Curve for the First Hour (AUC0-60) (time frame: Predose up to 60 minutes postdose).

It also tracked 3 secondary outcomes, for example Maximum Serum Insulin Concentration (Cmax), Time to Maximum Serum Insulin Concentration (Tmax) and Area Under the Blood Glucose Time-Concentration Curve Blood Glucose (AUC[BG]).

What This Means in Plain Language

Put simply, this is a phase 2 trial of Insulin Lispro in 22 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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