At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
AN OPEN-LABEL, RANDOMIZED, MULTICENTER, PHASE 3 STUDY TO COMPARE THE IMMUNOGENICITY, EFFICACY, AND SAFETY OF GAN & LEE PHARMACEUTICALS INSULIN GLARGINE INJECTION TO LANTUS® IN ADULT SUBJECTS WITH TYPE 2 DIABETES MELLITUS
In Brief
A Phase 3 clinical trial evaluating Gan & Lee Insulin Glargine Injection and Lantus® for Diabetes Mellitus, Type 2. Completed, enrolled 567 participants across 57 sites.
Detailed Summary
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 (AIA) at baseline who develop confirmed positive AIA up to Week 26, the percentage of subjects with at least a 4-fold increase in titers compared to baseline value, mean change from 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 the percentage of subjects in each treatment group with confirmed positive AIA up to visit Week 26 Safety: • To evaluate the safety of Gan \& Lee Insulin Glargine Injection in comparison with that of Lantus® Efficacy: • To evaluate the efficacy of Gan \& Lee Insulin Glargine Injection in comparison with that of Lantus®
Study Details
Timeline
Interventions
Route of administration: subcutaneous injection
Route of administration: subcutaneous injection