Gan & Lee Evaluation of New Biosimilar for Type 1 Lispro

What Was Tested

The trial (phase 3) is built around Insulin Lispro.

It had two arms (groups): Experimental: Gan & Lee Insulin Lispro Injection (experimental) and Active Comparator: Humalog (active comparator).

The registry classes the interventions as biological.

Who Took Part

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Male or nonpregnant, non-lactating female subjects between the ages of 18 and 75 years, inclusive. Ability to understand and fully comply with all study procedures and restrictions. Do not expect to change the brand or type of their basal insulin during the study. C-peptide ≤ 1.0 ng/mL. Body mass index (BMI) ≥ 19 kg/m2 and ≤ 35 kg/m2.

The full record lists 10 inclusion and 26 exclusion criteria; among the exclusions: previous use of gan \& lee insulin lispro injection; use of insulin neutral protamine hagedorn or insulin detemir within 6 months prior to study entry; current or expected use of an insulin pump or use of continuous glucose measurement to monitor blood glucose during the study.

How the Study Was Run

Design: randomized, parallel-group and open-label.

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

The Insulin Lispro group and the comparison group ran side by side rather than switching.

Being open-label, the Insulin Lispro study did not mask who received what.

It started in 2019-12-04 with completion listed for 2020-01-27.

It ran at 107 sites in United States (58), Poland (16), Spain (12), Hungary (11), Czechia (5) and Germany (5).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 8 secondary outcomes, for example Percentage of subjects with negative AIA at baseline who develop positive AIA after baseline, Mean change from baseline in AIA titers, Percentage of subjects with confirmed positive AIA who develop anti-insulin NAbs, Percentage of subjects with positive AIA after baseline, Incidence and severity of all treatment-emergent adverse events and Change from baseline in HbA1c at visit Week 26.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Lispro in people.

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

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