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Gan & Lee Evaluation of New Biosimilar for Type 1 Lispro

NCT04254380 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2020-02-05

No results posted yet for this study

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

BIOLOGICAL

Gan & Lee Insulin Lispro Injection

Route of administration: subcutaneous injection

BIOLOGICAL

Humalog

Route of administration: subcutaneous injection

Sponsors & Collaborators

  • Gan and Lee Pharmaceuticals, USA

    lead INDUSTRY

Principal Investigators

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

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
2019-12-04
Primary Completion
2020-01-27
Completion
2020-01-27
FDA Drug
Yes

Countries

  • United States
  • Czechia
  • Germany
  • Hungary
  • Poland
  • Spain

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 NCT04254380 on ClinicalTrials.gov