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PK/PD Biosimilarity Study of Gan & Lee Insulin Glargine Injection vs.US & EU Lantus® in Type 1 Diabetes Mellitus Patients

NCT04236895 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2020-01-22

No results posted yet for this study

Summary

Primary objectives:

To demonstrate biosimilarity with regard to the total and maximum pharmacokinetic exposure during one dosing interval (AUC ins. 0-24h, Cins.

max) of Gan \& Lee Insulin Glargine with Lantus® (US RLD / EU RP) in subjects with type 1 diabetes

To demonstrate biosimilarity with regard to the total and maximum pharmacodynamic response during one dosing interval (AUC GIR.0-24h, GIR max) of Gan \& Lee Insulin Glargine with Lantus® (US RLD / EU RP) in subjects with type 1 diabetes

Secondary objectives:

To compare the pharmacokinetic and pharmacodynamic properties of Gan \& Lee Insulin Glargine and of Lantus® (US RLD / EU RP)

To assess the safety and tolerability of Gan \& Lee Insulin Glargine and of Lantus® (US RLD / EU RP)

Conditions

  • Diabetes Mellitus, Type 1

Interventions

DRUG

Gan & Lee Insulin Glargine Injection

All IMPs will be administered as a 0.5 U/kg single subcutaneous dose by a pre-filled pen.

Sponsors & Collaborators

  • Gan and Lee Pharmaceuticals, USA

    lead INDUSTRY

Principal Investigators

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

  • Leona Plum - Mörschel, MD, PD · Profil Mainz GmbH & Co KG

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-10
Primary Completion
2018-11-28
Completion
2018-11-28
FDA Drug
Yes

Countries

  • Germany

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 NCT04236895 on ClinicalTrials.gov