NCT03371108

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 567 (actual)
• Sponsor: Gan and Lee Pharmaceuticals, USA · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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®

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
BIOLOGICAL	Gan & Lee Insulin Glargine Injection	Route of administration: subcutaneous injection
BIOLOGICAL	Lantus®	Route of administration: subcutaneous injection

Timeline

• Start date: 2017-10-31
• Primary completion: 2019-04-17
• Completion: 2019-04-17
• First posted: 2017-12-13
• Last updated: 2022-04-01
• Results posted: 2022-03-23

Locations

57 sites across 1 country: United States

Regulatory

• FDA-regulated drug study