A Study to Demonstrate Pharmacokinetic and Pharmacodynamic Biosimilarity Between HEC-Glargine and US-Lantus® in Healthy Male Volunteers

What Was Tested

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

It had two arms (groups): HEC-Glargine Treatment A (Test) (experimental) and US-Lantus Treatment B (Reference) (active comparator).

The registry classes the interventions as drug.

More on the Plan

The study population consists of healthy adult male subjects.

There will be a wash-out period of at least 7 calendar days.

Each subject will receive both test and reference products in a crossover pattern over Treatment Periods 1 and 2.

Who Took Part

Enrollment: 104 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: Participant has body weight not less than 60 kg and body mass index between 18.5 and 30.0 kg/m\^2 (both inclusive). Normal oral glucose tolerance test conducted within the previous 6 months. Medical history, vital signs, physical examination, standard 12-lead electrocardiogram (ECG) and laboratory investigations should be clinically acceptable or within laboratory reference ranges for the relevant laboratory tests. Non-smokers or mild to moderate smokers (≤ 10 cigarettes or pipes per day).

The full record lists 5 inclusion and 17 exclusion criteria; among the exclusions: regular exposure to substances of abuse (other than alcohol) within the past year; use of any medication, prescribed or over-the-counter or herbal remedies; positive test for insulin antibodies.

How the Study Was Run

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

Because people in this Insulin Glargine 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 Glargine 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 Glargine.

Those kept unaware of assignments: participant and investigator.

It started in 2022-03-08 with completion listed for 2022-08-31.

It ran at 1 site in South Africa.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Area under the concentration-time curve from 0 hours to 24 hours (AUC0-24h) of M1 (time frame: Day 1 and Day 2). Maximum observed plasma exogenous insulin glargine concentration (Cmax) of M1 (time frame: Day 1 and Day 2). Area under the Glucose infusion rate (GIR) -time curve (calculated as the exact area under the stepwise constant function) from 0 hours to 24 hours (GIRAUC0-24h) (time frame: Day 1 and Day 2).

It also tracked 24 secondary outcomes, for example Area under the concentration-time curve from 0 hours to the last quantifiable concentration-time (AUC0-t), Area under the concentration-time curve from 0 hours to 6 hours (AUC0-6h), Area under the concentration-time curve from 6 hours to 12 hours (AUC6-12h), Area under the concentration-time curve from 0 hours to 12 hours (AUC0-12h), Area under the concentration-time curve from 12 hours to 18 hours (AUC12-18h) and Area under the concentration-time curve from 18 hours to 24 hours (AUC18-24h).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Glargine in 104 people.

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

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