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Gan & Lee Evaluation of New Biosimilar for Type 1 Lispro — GENTL 1  

Diabetes Mellitus, Type 1 Clinical Trial

Official title:
An Open-label, Randomized, Multicenter, Phase 3 Study to Compare the Immunogenicity, Efficacy, and Safety of Gan & Lee Insulin Lispro Injection to Humalog in Adult Subjects With Type 1 Diabetes Mellitus (T1DM)

Clinical Trial 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

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04254380
Study type Interventional
Source Gan and Lee Pharmaceuticals, USA
Contact
Status Withdrawn
Phase Phase 3
Start date December 4, 2019
Completion date January 27, 2020
View Details
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