Comparison of the Pharmacokinetics (PK) and Pharmacodynamics (PD) Biosimilarity of Proposed Biosimilar Rapid-Acting Insulin Aspart (I004) and NovoLog After Single-Dose Subcutaneous Administration to Healthy Volunteers

What Was Tested

This registered phase 2, phase 3 trial tested Insulin Aspart.

This study is a randomized, double-blinded, two-treatment, two-period, two-sequence crossover pivotal Biosimilar study.

It had two arms (groups): Insulin Aspart, I004 (experimental) and NovoLog (active comparator).

Participants who were dosed with I004.

Participants who were dosed with NovoLog.

The registry classes the interventions as drug.

Who Took Part

The registry lists 69 actual participants took part.

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

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

Examples of who could join: Upon review, agree to participate and sign informed consent. Healthy male and female subjects ≥ 18 to ≤ 65 years of age. Body mass index (BMI) ≥ 18.5 to ≤ 29.9 kg/m2. Weight ≥ 50 kg. Non-smoker for ≥ 3 months prior to Screening.

The full record lists 8 inclusion and 19 exclusion criteria; among the exclusions: history of diabetes mellitus; resting blood pressure (bp) \> 140/90 mmhg or \< 90/60 mmhg. subjects bp may be re-checked; history of any serious adverse reaction or hypersensitivity to any of the investigational product components.

How the Study Was Run

Design: randomized, crossover and quadruple-blind.

Because people in this Insulin Aspart study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Blinding on both sides kept the participants and researchers unaware of who received Insulin Aspart.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2022-08-22 with completion listed for 2023-01-29.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Maximum Serum Insulin Aspart Concentration, CIAmax. Maximum Glucose Infusion Rate, Gmax.

It also tracked 25 secondary outcomes, for example Area Under the Curve (AUC) of Insulin Aspart Serum Concentration From Time 0 to Infinity, AUCIA(0-∞), Time of Maximum Insulin Aspart Serum Concentration, tIAmax, Apparent Clearance of Insulin Aspart, CL/F, Apparent Volume of Distribution of Insulin Aspart, Vz/F, Half-life of Insulin Aspart, t1/2 and Maximum Serum Human Insulin Concentration, CHImax.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Insulin Aspart in 69 people.

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

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