Pharmacokinetic (PK), Pharmacodynamic (PD), and Safety Study of Subcutaneously Administered Humalog® With and Without Recombinant Human Hyaluronidase (rHuPH20)and Humulin-R® With and Without rHuPH20

What Was Tested

The trial (phase 1) is built around Insulin Lispro.

The study hypothesizes that the time required to reach maximum insulin concentration (tmax) when insulin is administered with rHuPH20 will be comparable or shorter than the time required without rHuPH20.

It had four arms (groups): Humalog first, then Humalog + rHuPH20 (active comparator), Humalog + rHuPH20 first, then Humalog (active comparator), Humulin-R first, then Humulin-R + rHuPH20 (active comparator) and Humulin-R + rHuPH20 first, then Humulin-R (active comparator).

The registry classes the interventions as drug.

Who Took Part

26 actual participants took part.

It was open to men only aged from 18 years up to 55 years.

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

Examples of who could join: Healthy male participants aged 18 to 55 years. Body mass index (BMI) 18 to 28 kilograms per meter squared (kg/m\^2) and total body weight \>70 kilograms (kg) (154 pounds \[lb\]). Willingness and ability to comply with the protocol. Vital signs within the normal range. Within 7 days before the first injection, metabolic panel results and complete blood count (CBC) within the laboratory normal reference range.

The full record lists 8 inclusion and 15 exclusion criteria; among the exclusions: known history of diabetes mellitus; prior exposure to any insulin or insulin analogs; known allergy to hyaluronidase or any other ingredient in hylenex.

How the Study Was Run

The set-up was randomized, crossover and double-blind.

Random assignment meant chance, not the researchers, decided who got Insulin Lispro and who got the comparison, which limits bias.

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

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

Those kept unaware of assignments: participant and investigator.

It started in 2007-12 with completion listed for 2008-02.

It ran at 1 site in United States.

Its stated primary purpose is health services research.

What Was Measured

The main thing measured (primary outcome): Time to Maximum Serum Insulin Concentration (Tmax) (time frame: Predose and up to 360 minutes postdose during Stage 1 or Stage 2). Maximum Serum Insulin Concentration (Cmax) (time frame: Predose and up to 360 minutes postdose during Stage 1 or Stage 2). Area Under the Serum Concentration-Time Curve From Time Zero to the Time Required to Reach Endogenous Plasma Glucose Levels (AUC[0-t']) (time frame: Predose and up to 360 minutes postdose during Stage 1 or Stage 2).

It also tracked 9 secondary outcomes, for example Time to Maximum Glucose Infusion Rate (tGIR[Max]), Maximum Glucose Infusion Rate (GIR[Max]), Area Under the Glucose Infusion Rate Curve From 0 to 60 Minutes After Injection (AUC[GIR{0-60}]), Area Under the Glucose Infusion Rate Curve From 0 to 120 Minutes After Injection (AUC[GIR{0-120}]), Area Under the Glucose Infusion Rate Curve From 0 to 180 Minutes After Injection (AUC[GIR{0-180}]) and Area Under the Glucose Infusion Rate Curve From 0 to 240 Minutes After Injection (AUC[GIR{0-240}]).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Lispro in 26 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.