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

NCT03371108 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 567

Last updated 2022-04-01

Study results available
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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®

Conditions

  • Diabetes Mellitus, Type 2

Interventions

BIOLOGICAL

Gan & Lee Insulin Glargine Injection

Route of administration: subcutaneous injection

BIOLOGICAL

Lantus®

Route of administration: subcutaneous injection

Sponsors & Collaborators

  • Gan and Lee Pharmaceuticals, USA

    lead INDUSTRY

Principal Investigators

  • Jia Lu, PhD · Gan & Lee Pharmaceuticals, USA

  • Elena A. Christofides, MD, FACE · Endocrinology Research Associates, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-31
Primary Completion
2019-04-17
Completion
2019-04-17
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03371108 on ClinicalTrials.gov