Pharmacokinetic and Glucodynamic Crossover Study of Subcutaneously (SC) Administered Insulin Lispro + Recombinant Human Hyaluronidase (rHuPH20) and Regular Human Insulin + rHuPH20 Compared to Insulin Lispro Alone

What Was Tested

This registered phase 1 trial tested Insulin (regular human) and Insulin Lispro.

Insulin lispro and regular human insulin are Food and Drug Administration (FDA)-approved medications for the treatment of diabetes mellitus.

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

It had 1 arm (groups): Insulin Lispro, Regular Human Insulin, rHuPH20 (experimental).

The registry classes the interventions as drug.

More on the Plan

The study drugs will be administered by subcutaneous (under the skin) injection.

Who Took Part

Enrollment: 22 actual participants took part.

It was open to people of any sex aged from 18 years up to 55 years.

Healthy volunteers could join, not only people with the condition.

The full record lists 9 inclusion and 12 exclusion criteria; among the exclusions: known history of diabetes mellitus (type 1 or type 2) or gestational diabetes; known allergy to hyaluronidase or any other ingredient in the study drug; positive human immunodeficiency virus (hiv 1) antibody test, hepatitis b (anti-hepatitis b surface antigen \[anti-hbsag\]) or hepatitis c (anti-hepatitis c virus \[anti-hcv\]) antibody test.

How the Study Was Run

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

Each person switched between Insulin (regular human) and the comparison at some point, usually with a gap in between.

As a double-blind Insulin (regular human) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2009-03 with completion listed for 2009-06.

It ran at 1 site in United States.

What Was Measured

Researchers chose this as the main measure: Intra-participant Variability in Percent of Total Area Under the Plasma Insulin Concentration-Versus-Time Curve Attained by Time T (%AUC[0-T]) (time frame: predose up to 30 minutes postdose).

It also tracked 5 secondary outcomes, for example Peak Serum Insulin Concentration (Cmax), Time to Percentage of Total Glucose Infused, Percentage of Total Glucose Infused and Number of Treatment Emergent Adverse Events (TEAEs) Related to Study Drug.

What This Means in Plain Language

Put simply, this is a phase 1 trial of Insulin (regular human) and 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 (regular human) compound page and the Insulin Lispro compound page, all human trials.