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

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®

Timeline

Start

2017-10-31

Primary completion

2019-04-17

Completion

2019-04-17

Publications

• Christofides EA, Puente O, Norwood P, Denham D, Maheshwari H, Lillestol M, Hart T, Nakhle S, Chadha A, Fitz-Patrick D, Sugimoto D, Soufer J, Young D, Warren M, Huffman D, Reed J, Bays H, Arora S, Rizzardi B, Tidman R, Rendell M, Johnson KA. Immunogenicity, efficacy, and safety of biosimilar insulin glargine (Gan & Lee glargine) compared with originator insulin glargine (Lantus(R)) in patients with type 2 diabetes after 26 weeks' treatment: A randomized open label study. Diabetes Obes Metab. 2024 Jun;26(6):2412-2421. doi: 10.1111/dom.15560. Epub 2024 Apr 1.

Drugs

Indications