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Clinical trialNCT03371082CompletedPhase 3Interventional

Gan & Lee Insulin Glargine Target Type (1) Evaluating Research

SponsorGan and Lee Pharmaceuticals, USAEnrollment576Diabetes Mellitus, Type 1
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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®.
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

85 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Czechia
  • Krajská Zdravotní, A.S., Masarykova Nemocnice V Ústí Nad Labem

    Ústí nad Labem, Severoceský KRAJ, Czechia

  • Diabetologie České Budějovice S.R.O

    České Budějovice, South Bohemian Region, Czechia

  • Diahaza S.R.O.

    Holešov, Czechia

  • Stefamed

    Hradec Králové, Czechia

  • Diabetologie Mudr. Tomáš Edelsberger

    Krnov, Czechia

  • Preventamed

    Olomouc, Czechia

  • Genom S.R.O

    Ostrava, Czechia

Germany
  • Studienzentrum Aschaffenburg

    Aschaffenburg, Bavaria, Germany

  • Diabetes-Falkensee.de

    Falkensee, Brandenburg, Germany

  • Gemeinschaftspraxis Diabeteszentrum Dortmund

    Dortmund, North Rhine-Westphalia, Germany

  • Diabetes Schwerpunktpraxis, Gemeinschaftspraxis Alain Barakat Und Helene Willems

    Duisburg, North Rhine-Westphalia, Germany

  • Diabetologische Schwerpunktpraxis Pirna

    Pirna, Saxony, Germany

  • Red-Institut Gmbh

    Oldenburg in Holstein, Schleswig-Holstein, Germany

Hungary
  • Cru Hungary Egészségügyi És Szolgáltató Kft.

    Miskolc, Borsod-Abauj Zemplen county, Hungary

  • Lausmed Egeszsegugyi Es Szolgaltato Kft.

    Baja, Bács-Kiskun county, Hungary

  • Markhot Ferenc Oktatókórház És Rendelointézet

    Eger, Heves County, Hungary

  • Zala County Hospital

    Zalaegerszeg, Zala County, Hungary

  • Betegapolo-Irgalmasrend Budai Irgalmasrendi Kórház, Diabetológiai Ambulancia

    Budapest, Hungary

  • Semmelweis Egyetem Ii. Sz. Belgyógyászati Klinika

    Budapest, Hungary

  • Synexus Magyarország

    Budapest, Hungary

Poland
  • Praktyka Lekarska Ewa Krzyzagórska

    Poznan, Greater Poland Voivodeship, Poland

  • Nzoz Medyczne Centrum Diabetologiczno-Endokrynologiczno-Metaboliczne "diab-Endo-Met"

    Krakow, Lesser Poland Voivodeship, Poland

  • Pratia Mcm Kraków

    Krakow, Lesser Poland Voivodeship, Poland

  • Ko-Med Centra Kliniczne Lublin - Królewska

    Lublin, Lublin Voivodeship, Poland

  • Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych I Administracji W Warszawie

    Warsaw, Masovian Voivodeship, Poland

  • Centrum Badań Klinicznych Pi-House

    Gdansk, Pomeranian Voivodeship, Poland

  • Niepubliczny Zaklad Opieki Zdrowotnej Gdanska Poradnia Cukrzycowa

    Gdansk, Pomeranian Voivodeship, Poland

Spain
  • Hospital Universitari de Girona Doctor Josep Trueta

    Girona, Gerona, Spain

  • Complejo Hospitalario Universitario de Ferrol

    Ferrol, LA Coruna, Spain

  • Centro de Especialidades San Jose Obrero. Hospital Universitario Virgen de la Victoria

    Málaga, Malaga, Spain

  • Complejo Hospitalario Universitario la Coruña

    A Coruña, Spain

  • Hospital Universitario Ramón Y Cajal

    Madrid, Spain

  • Hospital Universitario Nuestra Señora de Valme

    Seville, Spain

  • Nuevas Tecnologías En Diabetes Y Endocrinología

    Seville, Spain

  • Consorci Hospital General Universitari de València

    Valencia, Spain

United States
  • University of Alabama at Birmingham

    Birmingham, Alabama, United States

  • Valley Research

    Fresno, California, United States

  • the Rose Salter Medical Research Foundation

    Newport Beach, California, United States

  • California Medical Research Association

    Northridge, California, United States

  • Metabolic Institute of America

    Tarzana, California, United States

45 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Gan & Lee Insulin Glargine InjectionLantus®
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
31 Oct 2017
Primary completion
19 Aug 2019
Completion
19 Aug 2019
Last update posted
14 May 2024
Registered enrollment
576
Registry id
NCT03371082
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 30 Jul 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.