PK/PD Biosimilarity Study of Gan & Lee Insulin Glargine Injection vs.US & EU Lantus® in Type 1 Diabetes Mellitus Patients

What Was Tested

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

It had three arms (groups): Lantus ® US (active comparator), Lantus ® EU (active comparator) and Gan & Lee Insulin Glargine (experimental).

The registry classes the interventions as drug.

Who Took Part

114 actual participants took part.

It was open to men only aged from 18 years up to 64 years.

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

Examples of who could join: Signed and dated informed consent obtained before any trial-related activities. (Trial-related activities are any procedures that would not have been performed during normal management of the subject). Male subjects with type 1 diabetes mellitus for at least 12 months prior to screening as diagnosed clinically. Age between 18 and 64 years, both inclusive. Body Mass Index (BMI) between 18.5 and 29.0 kg/m\^2, both inclusive. Stable insulin regimen for at least 2 months prior to screening (with respect to safety of the subject and scientific integrity of the trial).

The full record lists 9 inclusion and 20 exclusion criteria; among the exclusions: known or suspected hypersensitivity to imps or related products; previous participation in this trial. participation is defined as randomized; receipt of any medicinal product in clinical development within 30 days or 5 half-lives (whichever is longer) before randomization in this trial.

How the Study Was Run

Design: randomized, crossover and double-blind.

Random assignment meant chance, not the researchers, decided who got Insulin Glargine and who got the comparison, which limits bias.

Each person switched between Insulin Glargine 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 Glargine, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2018-07-10 with completion listed for 2018-11-28.

It ran at 2 sites in Germany (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: PK endpoint (time frame: Up to 24 hours). PK endpoint (time frame: Up to 30 hrs). PD endpoint (time frame: Up to 24 hours).

It also tracked 10 secondary outcomes, for example Secondary PK endpoint, Secondary PK endpoint, Exploratory PK endpoint, Exploratory PK endpoint, Secondary PD endpoint and Secondary PD endpoint.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Glargine in 114 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.