Pharmacokinetic and Pharmacodynamic Equivalence of Biosimilar and Reference Ultra-Rapid Lispro: A Comparative Clamp Study in Healthy Volunteers

What Was Tested

Researchers studied Insulin Lispro in this randomized controlled trial publication.

Blood samples were collected at predefined intervals up to 8 hours to assess PK parameters.

Why It Was Studied

Ultra-rapid insulin lispro is an innovative insulin analogue designed to achieve rapid onset and short duration of action, aimed at optimizing glycemic control in patients with diabetes.

A total of 35 healthy volunteers completed hyperinsulinemic euglycemic clamp procedures across both study periods.

Who Took Part

The abstract describes 35 volunteers taking part.

By PubMed's age tags, the people studied were young adults and adults, men only.

How the Study Was Run

The design is described as randomized, double-blind and crossover.

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

Blinding on both sides kept the volunteers and researchers unaware of who received Insulin Lispro.

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

What Was Measured

Plasma glucose levels were monitored every 5 minutes during the 8-hour clamps, with adjustments to the glucose infusion rate to maintain the target range.

Topics PubMed links to this paper include Insulin Lispro, Glucose Clamp Technique, Therapeutic Equivalency, Healthy Volunteers, Blood Glucose, Hypoglycemic Agents and Area Under Curve.

The authors tagged it with the keywords bioequivalence, comparability, diabetes, hyperinsulinemic euglycemic clamp and phase I study.

What This Means in Plain Language

The paper is a randomized, double-blind and crossover study of Insulin Lispro in 35 volunteers.

With fewer than 40 people, it is a small study, so it is better read as an early signal for further research than as a settled answer.

The publication is from 2025 (Clinical pharmacology in drug development), a journal based in United States.

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