Gan & Lee Insulin Glargine Target Type (2) Evaluating Research

What Was Tested

In this phase 3 trial, researchers set out to test Insulin Glargine.

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: 567 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. Subjects with a confirmed diagnosis of type 2 diabetes mellitus who meet one of the following:. If insulin-naïve, subjects should have been on at least 2 approved OAMs for at least 12 weeks before screening, and the clinician has decided to add insulin therapy. HbA1c values as follows:.

The full record lists 12 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

It was run as a randomized, parallel-group and open-label study.

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.

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

It started in 2017-10-31 with completion listed for 2019-04-17.

It ran at 57 sites in United States (57).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Treatment-induced Anti-Insulin Antibody (TI-AIA) is the Primary Endpoint (time frame: Baseline to Week 26).

It also tracked 8 secondary outcomes, for example CFB in HbA1c to Week 26, Immunogenicity - Mean Change From Baseline in Each Treatment Group in AIA Titers After Baseline and Immunogenicity - Percentage of Subjects With Confirmed Positive AIA After Baseline.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine in 567 people.

With 567 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.