NCT04254380

Gan & Lee Evaluation of New Biosimilar for Type 1 Lispro

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)

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Gan and Lee Pharmaceuticals, USA · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
BIOLOGICAL	Gan & Lee Insulin Lispro Injection	Route of administration: subcutaneous injection
BIOLOGICAL	Humalog	Route of administration: subcutaneous injection

Timeline

• Start date: 2019-12-04
• Primary completion: 2020-01-27
• Completion: 2020-01-27
• First posted: 2020-02-05
• Last updated: 2020-02-05

Locations

107 sites across 6 countries: United States, Czechia, Germany, Hungary, Poland, Spain

Regulatory

• FDA-regulated drug study