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

What Was Tested

In this phase 2, phase 3 trial, researchers set out to test 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

62 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 21 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

It was run as a randomized, crossover and quadruple-blind study.

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

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

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

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

It started in 2026-04-06 with completion listed for 2026-06-22.

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 19 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 62 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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