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 1 Diabetes Mellitus.
In Brief
A Phase 3 clinical trial evaluating Gan & Lee Insulin Glargine Injection and Lantus® for Diabetes Mellitus, Type 1. Completed, enrolled 576 participants across 85 sites in 6 countries.
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 (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®. 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