Liquid Meal Study With Insulin Lispro With/Without Recombinant Human Hyaluronidase PH20 (rHuPH20) and Regular Human Insulin With rHuPH20 to Compare Pharmacokinetics, Postprandial Glycemic Response, and Optimal Insulin Dose in Participants With Type 2 Diabetes Mellitus (T2DM)

What Was Tested

The trial (phase 2) is built around Insulin Lispro.

It had six arms (groups): Humalog, Then Humalog + rHuPH20, Then Humulin-R + rHuPH20 (active comparator), Humalog, Then Humulin-R + rHuPH20, Then Humalog + rHuPH20 (active comparator), Humalog + rHuPH20, Then Humalog, Then Humulin-R + rHuPH20 (active comparator), Humalog + rHuPH20, Then Humulin-R + rHuPH20, Then Humalog (active comparator) and Humulin-R + rHuPH20, Then Humalog, Then Humalog + rHuPH20 (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 23 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Male or female of age 18 to 70 years, inclusive. Participants with Type 2 diabetes mellitus (T2DM) per World Health Organization criteria treated with basal and/or bolus insulin for ≥12 months. Body mass index (BMI) between 18 to 45 kilograms per square meter (kg/m\^2), inclusive. Total body weight \>65 kilograms (kg) (143 pounds \[lb\]) for men and \>46 kg (101 lb) for women. Decision making capacity and willingness to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures including adequate venous access.

The full record lists 11 inclusion and 16 exclusion criteria; among the exclusions: known or suspected allergy to any components of any of the study drugs in this study; previous enrollment in this study; A participant who has proliferative retinopathy, proliferative maculopathy, and/or severe neuropathy (in particular, autonomic neuropathy) as judged by the Investigator.

How the Study Was Run

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

The participants were allocated by chance, so the Insulin Lispro group and the comparison group should start out alike.

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

Neither the participants nor the staff measuring them knew who was on Insulin Lispro, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2009-07 with completion listed for 2009-11.

It ran at 1 site in United States.

What Was Measured

Researchers chose this as the main measure: Postprandial Glucose (PPG) Excursion Following a Liquid Meal (time frame: Predose up to 480 minutes after study drug injection).

It also tracked 10 secondary outcomes, for example Maximum Serum Insulin Concentration (Cmax), Time To Maximum Serum Insulin Concentration (Tmax), Mean Residence Time From Time 0 to the End of Blood Sampling (MRT[Last]), Area Under the Concentration Time-Curve for Serum Insulin From Time 0 to the End of Blood Sampling (AUC[Last]), Area Under the Time-Concentration Curve for Blood Glucose (AUC[BG]) and Minimum Postprandial Glucose (PPG).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin Lispro in 23 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.