Gan & Lee Evaluation of New Biosimilar for Type 1 Lispro

Summary

Primary Objective: • To compare the immunogenicity of Gan \& Lee Insulin Lispro Injection and EU-authorized Humalog following treatment in adult subjects with T1DM Secondary Objectives: * To evaluate the safety of Gan \& Lee Insulin Lispro Injection in comparison with that of EU authorized Humalog following treatment in adult subjects with T1DM * To evaluate the efficacy of Gan \& Lee Insulin Lispro Injection in comparison with that of EU authorized Humalog following treatment in adult subjects with T1DM

Timeline

Start

2019-12-04

Primary completion

2020-01-27

Completion

2020-01-27

Drugs

Indications