NCT03371082

Gan & Lee Insulin Glargine Target Type (1) 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 1 Diabetes Mellitus.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 576 (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 (AIAs) at baseline who develop confirmed positive AIA up to Week 26, the percentage of 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 percentage of subjects who develop confirmed positive AIA up to visit Week 26 of Gan \& Lee Insulin Glargine Injection in comparison with that of Lantus®. 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 1

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: 2019-08-19
• Completion: 2019-08-19
• First posted: 2017-12-13
• Last updated: 2024-05-14
• Results posted: 2024-05-14

Locations

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

Regulatory

• FDA-regulated drug study