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Diabetes Mellitus, Type 1Phase 3GENTL 1NCT04254380

Gan & Lee Evaluation of New Biosimilar for Type 1 Lispro

A Phase 3 study testing Gan & Lee Insulin Lispro Injection and Humalog in people with Diabetes Mellitus, Type 1, run by Gan and Lee Pharmaceuticals, USA at 107 sites in 6 countries.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Diabetes Mellitus, Type 1
What is being tested?
Gan & Lee Insulin Lispro Injection and Humalog
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
107 sitesin 6 countries
Study dates
4 Dec 2019to 27 Jan 2020
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or nonpregnant, non-lactating female subjects between the ages of 18 and 75 years, inclusive.
  • Female subjects of child-bearing potential, willing to use contraceptive method(s), agreed by the Investigator, to prevent pregnancy during the study.
  • Ability to provide written, personally signed, and dated informed consent to participate in the study, in accordance with the ICH GCP Guideline E6 and all applicable regulations, before initiating any study related procedures.
  • Ability to understand and fully comply with all study procedures and restrictions.
  • A confirmed diagnosis of T1DM and who have been on an approved basal-bolus insulin regimen for at least 6 months prior to Screening. The type or brand of insulins should not have changed in the 6 months before Screening.
  • Do not expect to change the brand or type of their basal insulin during the study.
Show all 10Show fewer
  • C-peptide ≤ 1.0 ng/mL
  • HbA1c ≤ 10.0%
  • Body mass index (BMI) ≥ 19 kg/m2 and ≤ 35 kg/m2
  • Adherence to a prudent diet and exercise regimen recommended by the medical provider in accordance with local standard of care or American Diabetes Association recommendations, and willingness to maintain this regimen consistently for the duration of the study.

Who cannot join

  • Participation in another clinical study within 30 days or 5 half-lives of last dose of experimental medication before Screening, whichever is longer.
  • Previous use of Gan \& Lee Insulin Lispro Injection.
  • Use of insulin neutral protamine hagedorn or insulin detemir within 6 months prior to study entry.
  • Current or expected use of an insulin pump or use of continuous glucose measurement to monitor blood glucose during the study.
  • Diabetic ketoacidosis (DKA) within 6 months before Screening.
  • Brittle T1DM within 1 year before Screening, defined as more than 2 hospitalizations related to diabetes mellitus (excluding hospitalizations for diagnostic purposes), and/or severe hypoglycemia for which the subject experiences severe cognitive impairment requiring external assistance for recovery.
Show all 26Show fewer
  • Renal replacement therapy required or with an estimated (or measured) glomerular filtration rate < 15 mL/min (Modification of Diet in Renal Disease calculation).
  • Any clinically significant cardiovascular (CV) or cerebrovascular event, e.g., myocardial infarction (MI), acute coronary syndrome (ACS), recent revascularization (including coronary artery bypass graft procedures [CABG], percutaneous coronary intervention [PCI]), transient ischemic attack (TIA), or hemorrhagic or ischemic stroke within 3 months before Screening.
  • History of congestive heart failure defined as New York Heart Association (NYHA) Stage III or IV.
  • Inadequately controlled or unstable hypertension as defined by a systolic blood pressure (SBP) > 160 mmHg or diastolic blood pressure (DBP) > 100 mmHg at Screening and/or Randomization.
  • Inadequately controlled thyroid disease, as reflected by abnormal TSH and free T4 values. (Hypothyroid or hyperthyroid conditions should be resolved or stabilized before Screening according to local standard of care).
  • Any clinically significant (in the opinion of the Investigator) hematology, chemistry, or urinalysis test results at Screening, including any liver function test > 3X of the upper limit of normal (ULN) or bilirubin > 1.5X of the ULN (subjects with elevated bilirubin due to Gilbert syndrome are eligible to participate, if such tests were performed in the past).
  • Autonomic neuropathy resulting in a diagnosis of gastroparesis.
  • Hemoglobin < 12 g/dL for males or < 11 g/dL for females at Screening.
  • Hospitalization within the 14 days before Screening, or planned hospitalization at any time during the study.
  • Newly prescribed or high-dose (60 mg/day prednisone or equivalent) treatment with glucocorticosteroids, immunosuppressants, or cytostatic agents due to disorders of the immunological system, such as rheumatoid arthritis, psoriasis, spondyloarthritis, and asthma, within 60 days before Screening (Medications under following scenario are allowed: chronically administered oral, inhaled, topical, or intra-articular corticosteroids at a stable dosage; stable therapy with disease modifying agents [e.g., methotrexate, sulfasalazine]; disease is inactive [e.g., remission, well controlled stable phase]; and no significant changes in treatment scheme are expected).
  • History of human immunodeficiency virus (HIV) or Hepatitis B or Hepatitis C infections.
  • Any unresolved infection or a history of active infection within 30 days before screening other than mild viral illness (as judged by the Investigator).
  • Current use of other medications for diabetes treatment, such as dipeptidyl peptidase 4 inhibitors (DPP4i), glucagon-like peptide 1 receptor agonists (GLP1-R), or sodium glucose cotransporter 2 inhibitors (SGLT2i) (See Appendix 1 [Section 16.1] for a list of prohibited medications).
  • A history of alcohol use of more than two drinks a day on average for the last year, or a history of alcohol or substance abuse within 2 years before Screening.
  • Previous (within 3 months before Screening) or anticipated treatment with interferons.
  • History of malignancy (except for treated non-melanoma skin cancer and treated cervical adenocarcinoma in situ) within 5 years before Screening
  • Receiving blood transfusion or undergoing plasmapheresis within 6 months before Screening.
  • History of splenectomy.
  • Intolerance or history of hypersensitivity to insulin lispro or any excipient of the study drugs.
  • Any other clinically significant medical or psychiatric condition, or one requiring further evaluation that in the opinion of the Investigator could interfere with conduct of the study or interpretation of the data.

Trial locations and contacts

107 sites in 6 countries.

107 sites in 6 countries

United States58 sites

  • The Endocrine Group, LLP

    Albany, New York, 12206

  • Amarillo Medical Specialists

    Amarillo, Texas, 79106

  • Advanced Research Center

    Anaheim, California, 92805

  • Atlanta Diabetes Associates

    Atlanta, Georgia, 30318

  • University of Colorado School of Medicine

    Aurora, Colorado, 80045

  • Austin Regional Clinic

    Austin, Texas, 78704

  • Texas Diabetes & Endocrinology - Central Austin

    Austin, Texas, 78731

  • Bay West Endocrinology Associates

    Baltimore, Maryland, 21204

  • BTC Network - Garden State Endocrinology - Brick

    Brick, New Jersey, 08723

  • BTC Network - Capital Diabetes and Endocrine Associates - Camp Springs

    Camp Springs, Maryland, 20746

  • University Diabetes & Endocrine Consultants

    Chattanooga, Tennessee, 37411

  • Cedar Crosse Research Center

    Chicago, Illinois, 60607

  • IACT Health - Columbus Regional Medical Group Endocrine Consultants - Columbus

    Columbus, Georgia, 31904

  • Endocrinology Research Associates

    Columbus, Ohio, 43201

  • Midwest CRC

    Crystal Lake, Illinois, 60012

  • Research Institute of Dallas

    Dallas, Texas, 75231

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • El Paso Medical Research Institute

    El Paso, Texas, 79935

  • The Center for Diabetes and Endocrine Care

    Fort Lauderdale, Florida, 33312

  • M & O Clinical Research

    Fort Lauderdale, Florida, 33316

  • Valley Research

    Fresno, California, 93720

  • PharmQuest

    Greensboro, North Carolina, 27408

  • Physicians East - Greenville

    Greenville, North Carolina, 27834

  • Chase Medical Research of Greater New Haven

    Hamden, Connecticut, 06517

  • Sweet Hope Research Specialty Inc.

    Hialeah, Florida, 33016

  • Homestead Associates in Research

    Homestead, Florida, 33032

  • Pioneer Research Solutions

    Houston, Texas, 77099

  • Palm Research Center

    Las Vegas, Nevada, 89148

  • Kentucky Diabetes Endocrinology Center

    Lexington, Kentucky, 40503

  • IMMUNOe International Research Centers - Longmont

    Longmont, Colorado, 80501

  • Angel City Research, Inc.

    Los Angeles, California, 90057

  • Your Diabetes Endocrine Nutrition Group, Inc.

    Mentor, Ohio, 44060

  • Med Research of Florida

    Miami, Florida, 33186

  • Carteret Medical Group - Morehead City

    Morehead City, North Carolina, 28557

  • North Shore Diabetes and Endocrine Associates

    New Hyde Park, New York, 11042

  • Suncoast Clinical Research - Pasco County

    New Port Richey, Florida, 34652

  • IACT Health - Columbus Regional Medical Group Endocrine Consultants

    Newnan, Georgia, 30265

  • Intend Research

    Norman, Oklahoma, 73069

  • California Medical Research Association

    Northridge, California, 91324

  • Quality Clinical Research

    Omaha, Nebraska, 68134

  • Florida Institute for Clinical Research, LLC

    Orlando, Florida, 32825

  • Ormond Beach Clinical Research

    Ormond Beach, Florida, 32174

  • Suncoast Clinical Research - Pinellas County

    Palm Harbor, Florida, 34684

  • Austin Regional Clinic - Kelly Lane

    Pflugerville, Texas, 78660

  • Endocrine & Metabolic Consultants

    Rockville, Maryland, 20852

  • Endocrine Research Solutions

    Roswell, Georgia, 30076

  • Clinical Trials of Texas, Inc.

    San Antonio, Texas, 78229

  • Mills-Peninsula Health Services

    San Mateo, California, 94401

  • Care Access Research - Santa Clarita

    Santa Clarita, California, 91321

  • Northeast Clinical Research of San Antonio

    Schertz, Texas, 78154

  • Meridien Research - Spring Hill

    Spring Hill, Florida, 34609

  • University Physicians Group

    Staten Island, New York, 10301

  • Lynn Institute of Stillwater

    Stillwater, Oklahoma, 73111

  • Metabolic Institute of America

    Tarzana, California, 91356

  • Crossroads Clinical Research

    Victoria, Texas, 77901

  • Care Access Research - Warwick

    Warwick, Rhode Island, 02886

  • Iowa Diabetes and Endocrinology Research Center

    West Des Moines, Iowa, 50265

  • Metabolic Research Institute

    West Palm Beach, Florida, 33401

Other trials in United States

Poland16 sites

  • Centrum Badań Klinicznych PI-House

    Gdansk, 80-546

  • Niepubliczny Zaklad Opieki Zdrowotnej Gdanska Poradnia Cukrzycowa

    Gdansk, 80-858

  • Centrum Medyczne Pratia Gdynia

    Gdynia, 81-338

  • Centrum Medyczne Pratia Katowice

    Katowice, 40-081

  • Pratia MCM Kraków

    Krakow, 30-510

  • NZOZ Medyczne Centrum Diabetologiczno-Endokrynologiczno-Metaboliczne "Diab-Endo-Met"

    Krakow, 31-261

  • CenterMed Lublin Sp. z o.o

    Lublin, 20 044

  • KO-MED Centra Kliniczne Lublin - Królewska

    Lublin, 20-109

  • Bogdan Walko Niepubliczny Zakład Opieki Zdrowotnej Przychodnia Specjalistyczna MEDICA

    Lublin, 20-538

  • Centrum Medyczne Grunwald

    Poznan, 60-369

  • Nasz Lekarz Przychodnie Medyczne

    Torun, 87-100

  • AMED Centrum Medyczne

    Warsaw, 01-518

  • Centralny Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji w Warszawie

    Warsaw, 02-507

  • Centrum Medyczne K2J2

    Wołomin, 05-230

  • Regionalna Poradnia Diabetologiczna

    Wroclaw, 50-127

  • Centrum Medyczne Oporów

    Wroclaw, 52-416

Other trials in Poland

Spain12 sites

  • Complejo Hospitalario Universitario La Coruña (Gerencia de Gestión Integrada de A Coruña)

    A Coruña, 15006

  • Hospital de la Santa Creu i de Sant Pau

    Barcelona, 8025

  • Hospital Universitari Vall d'Hebrón

    Barcelona, 8035

  • Complejo Hospitalario Universitario de Ferrol

    Ferrol, 15405

  • Hospital Universitari Arnau de Vilanova

    Lleida, 25198

  • Hospital Universitario de La Princesa

    Madrid, 28006

  • Hospital Universitario Ramón Y Cajal

    Madrid, 28034

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29006

  • Fundació Hospital de l'Esperit Sant

    Santa Coloma de Gramenet, 8923

  • Nuevas Tecnologías en Diabetes y Endocrinología

    Seville, 41003

  • Hospital Universitario Virgen Macarena

    Seville, 41009

  • Hospital Universitario Virgen de Valme

    Seville, 41014

Other trials in Spain

Hungary11 sites

  • Lausmed Egeszsegugyi es Szolgaltato Kft.

    Baja, 6500

  • Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet

    Budapest, 1097

  • Bajcsy-Zsilinszky Kórház és Rendelőintézet

    Budapest, 1106

  • Trantor 99 Bt Anyagcsere Centrum

    Budapest, 1213

  • Debreceni Egyetem Kenézy Gyula Egyetemi Kórház

    Debrecen, 4031

  • Békés Megyei Központi Kórház Pándy Kálmán Tagkórház

    Gyula, 5700

  • Somogy Megyei Kaposi Mór Oktató Kórház

    Kaposvár, 7400

  • Kanizsai Dorottya Kórház

    Nagykanizsa, 8801

  • Markusovszky Egyetemi Oktatokorhaz

    Szombathely, 9700

  • Medical-Expert Kutatási - Kísérleti és Szolgáltató Kft

    Veszprém, 8200

  • Zala Megyei Szent Rafael Kórház

    Zalaegerszeg, 8900

Other trials in Hungary

Czechia5 sites

  • Diabetologie České Budějovice s.r.o

    České Budějovice, South Bohemian Region, 370 01

  • Diahaza s.r.o.

    Holešov, 769 01

  • StefaMed

    Hradec Králové, 503 41

  • Clintrial

    Prague, 100 00

  • Milan Kvapil s.r.o

    Prague, 149 00

Other trials in Czechia

Germany5 sites

  • Diabeteszentrum DO

    Dortmund, 44137

  • Diabetes Schwerpunktpraxis

    Duisburg, 47051

  • Diabetes-falkensee.de - Zentrum für klinische Studien

    Falkensee, 14612

  • RED-Institut GmbH

    Oldenburg, 23758

  • Diabetologische Praxis

    Saarlouis, 66740

Other trials in Germany

About this study

Official title: An Open-label, Randomized, Multicenter, Phase 3 Study to Compare the Immunogenicity, Efficacy, and Safety of Gan & Lee Insulin Lispro Injection to Humalog in Adult Subjects With Type 1 Diabetes Mellitus (T1DM)

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
Being tested
Gan & Lee Insulin Lispro Injection, Humalog
Keywords
Diabetes, Diabetes Type 1, Type 1, Basal, Insulin, Lispro, T1DM, Diabetes Mellitus, Insulin Dependent Diabetes
Medical subject headings
Diabetes Mellitus, Type 1, Diabetes Mellitus, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gan & Lee Insulin Lispro InjectionBiological

    Route of administration: subcutaneous injection

  • HumalogBiological

    Route of administration: subcutaneous injection

Study groups in NCT04254380
Study groupRoleWhat they receive
Experimental: Gan & Lee Insulin Lispro InjectionExperimentalGan \& Lee Insulin Lispro Injection for subcutaneous injection, 100 U/mL, in a disposable multidose pen injector with a pre-filled 3-mL type I glass cartridge. Subjects randomized to the Gan \& Lee Insulin Lispro Injection group will participate in the study for 26 weeks.
Receives: Biological: Gan & Lee Insulin Lispro Injection
Active Comparator: HumalogActive comparatorEU-authorized Humalog KwikPen® - insulin lispro injection, solution for subcutaneous injection, 100 U/mL (pre-filled). Subjects randomized to the Humalog group will participate in the study for 26 weeks.
Receives: Biological: Humalog

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Treatment developed AIAs or important increase in AIA titers

    The percentage of subjects in each treatment group who develop treatment induced AIAs, defined as newly confirmed positive AIA development or important (at least a 4-fold) increase in titers after baseline and up to visit Week 26.

    Measured: Week 1 to Week 26

Secondary outcomes (8)

  1. Percentage of subjects with negative AIA at baseline who develop positive AIA after baseline

    The percentage of subjects in each treatment group with negative AIA at baseline who develop confirmed positive AIA after baseline and up to visit Week 26.

    Measured: Week 1 to Week 26

  2. Percentage of subjects with important increase in titers

    The percentage of subjects in each treatment group with confirmed positive AIA at baseline and at least a 4-fold increase in titers after baseline and up to visit Week 26.

    Measured: Week 1 to Week 26

  3. Mean change from baseline in AIA titers

    The mean change from baseline in each treatment group in AIA titers after baseline and up to visit Week 26.

    Measured: Week 1 to Week 26

  4. Percentage of subjects with confirmed positive AIA who develop anti-insulin NAbs

    The percentage of subjects in each treatment group with confirmed positive AIA after baseline and up to visit Week 26 who develop any anti-insulin NAbs after baseline and up to visit Week 26.

    Measured: Week 1 to Week 26

  5. Percentage of subjects with positive AIA after baseline

    The percentage of subjects in each treatment group with confirmed positive AIA after baseline and up to visit Week 26.

    Measured: Week 1 to Week 26

  6. Incidence and severity of all treatment-emergent adverse events

    The incidence and severity of all treatment-emergent adverse events and the following subgroups:

    Adverse events of special interest. Serious adverse events, including fatal events. Adverse events leading to termination of the study treatment and/or early withdrawal from the study.

    Treatment-related adverse events. IP device-related adverse events. Injection site reactions. The incidence of clinically significant laboratory abnormalities. The incidence of clinically significant abnormalities in physical examination and vital signs.

    Measured: Week 1 to Week 26

  7. Change from baseline in HbA1c at visit Week 26

    Change from baseline in HbA1c at visit Week 26 in each treatment group.

    Measured: Week 1 to Week 26

  8. Percentage of subjects who achieve an HbA1c of ≤ 7.0% at visit Week 26

    The number and percentage of subjects who achieve an HbA1c of ≤ 7.0% at visit Week 26 in each treatment group.

    Measured: Week 1 to Week 26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2020
  2. Study start4 Dec 2019
  3. Primary completion27 Jan 2020
  4. Study completion27 Jan 2020

Why it stopped: GanLee cancelled study -FDA Draft Guidance: "Clinical Immunogenicity Considerations for Biosimilar \& Interchangeable Insulin Products" released 11/25/2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Subjects who meet the eligibility criteria will be centrally randomized 1:1 in an open-label fashion to receive either Gan \& Lee Insulin Lispro Injection or Humalog for 26 weeks. Randomization will be stratified by country.
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04254380
Sponsor's protocol ID
GL-LSPT1-3003
Acronym
GENTL 1
Status last verified
Feb 2020
First submitted
13 Jan 2020
Last updated
5 Feb 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Gan & Lee Insulin Lispro Injection and Humalog in people with Diabetes Mellitus, Type 1, run by Gan and Lee Pharmaceuticals, USA at 107 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 107 sites in United States, Poland, Spain, Hungary, Czechia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment developed AIAs or important increase in AIA titers (time frame: Week 1 to Week 26). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04254380.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.

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