Gan & Lee Insulin Glargine Target Type (1) Evaluating Research

What Was Tested

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

Primary Objective: •To evaluate equivalence of Gan \& Lee Insulin Glargine Injection and Lantus® in terms of immunogenicity Secondary Objective: Immunogenicity: • To evaluate the percentage of subjects with negative anti-insulin antibodies (AIAs) at baseline who develop confirmed positive AIA up to Week 26, the percentage of baseline in AIA titers between treatment groups, the percentage of subjects with confirmed positive AIA who develop any anti-insulin neutralizing antibodies up to visit Week 26, and percentage of subjects who develop confirmed positive AIA up to visit Week 26 of Gan \& Lee Insulin Glargine Injection in comparison with that of Lantus®.

Safety: •To evaluate the safety of Gan \& Lee Insulin Glargine Injection in comparison with that of Lantus®.

It had two arms (groups): Gan & Lee Insulin Glargine Injection (experimental) and Lantus® (active comparator).

The registry classes the interventions as biological.

Who Took Part

Enrollment: 576 actual participants 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, nonlactating female subjects between the ages of 18 and 75 years, inclusive. Ability to understand and fully comply with all study procedures and restrictions. BMI ≥ 19 kg/m2 and ≤ 35 kg/m2. Adherence to a prudent diet and exercise regimen recommended by the medical provider, and willingness to maintain these consistently for the duration of the study.

The full record lists 8 inclusion and 24 exclusion criteria; among the exclusions: participation in another clinical study or use of any study drug within 30 days before screening; previous use of a biosimilar insulin, either basal or bolus; diabetic ketoacidosis within a year before screening.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

Everyone knew when Insulin Glargine was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2017-10-31 with completion listed for 2019-08-19.

It ran at 85 sites in United States (50), Spain (8), Czechia (7), Hungary (7), Poland (7) and Germany (6).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Treatment-induced Anti-Insulin Antibody (TI-AIA) (time frame: Assessed up to Week 26).

It also tracked 8 secondary outcomes, for example Glycosylated Hemoglobin HbA1c, Number of Subjects in Each Treatment Group With Negative AIA at Baseline Who Develop Confirmed Positive AIA After Baseline, Mean Change From Baseline in Each Treatment Group in AIA Titers After Baseline, Number of Subjects With Confirmed Positive AIA After Baseline Who Develop Any Anti-insulin Neutralizing Antibodies After Baseline, Number of Subjects With Confirmed Positive AIA After Baseline and Postbaseline FBG Control.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine in 576 people.

With 576 participants it is a large trial for this field.

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

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