Gan & Lee Evaluation of New Biosimilar for Type 1 Lispro
NCT ID: NCT04254380
Last Updated: 2020-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2019-12-04
2020-01-27
Brief Summary
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• 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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental: Gan & Lee Insulin Lispro Injection
Gan \& 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.
Gan & Lee Insulin Lispro Injection
Route of administration: subcutaneous injection
Active Comparator: Humalog
EU-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.
Humalog
Route of administration: subcutaneous injection
Interventions
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Gan & Lee Insulin Lispro Injection
Route of administration: subcutaneous injection
Humalog
Route of administration: subcutaneous injection
Eligibility Criteria
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Inclusion Criteria
2. Female subjects of child-bearing potential, willing to use contraceptive method(s), agreed by the Investigator, to prevent pregnancy during the study.
3. 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.
4. Ability to understand and fully comply with all study procedures and restrictions.
5. 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.
6. Do not expect to change the brand or type of their basal insulin during the study.
7. C-peptide ≤ 1.0 ng/mL
8. HbA1c ≤ 10.0%
9. Body mass index (BMI) ≥ 19 kg/m2 and ≤ 35 kg/m2
10. 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.
Exclusion Criteria
2. Previous use of Gan \& Lee Insulin Lispro Injection.
3. Use of insulin neutral protamine hagedorn or insulin detemir within 6 months prior to study entry.
4. Current or expected use of an insulin pump or use of continuous glucose measurement to monitor blood glucose during the study.
5. Diabetic ketoacidosis (DKA) within 6 months before Screening.
6. 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.
7. Renal replacement therapy required or with an estimated (or measured) glomerular filtration rate \< 15 mL/min (Modification of Diet in Renal Disease calculation).
8. 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.
9. History of congestive heart failure defined as New York Heart Association (NYHA) Stage III or IV.
10. 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.
11. 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).
12. 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).
13. Autonomic neuropathy resulting in a diagnosis of gastroparesis.
14. Hemoglobin \< 12 g/dL for males or \< 11 g/dL for females at Screening.
15. Hospitalization within the 14 days before Screening, or planned hospitalization at any time during the study.
16. 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).
17. History of human immunodeficiency virus (HIV) or Hepatitis B or Hepatitis C infections.
18. Any unresolved infection or a history of active infection within 30 days before screening other than mild viral illness (as judged by the Investigator).
19. 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).
20. 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.
21. Previous (within 3 months before Screening) or anticipated treatment with interferons.
22. History of malignancy (except for treated non-melanoma skin cancer and treated cervical adenocarcinoma in situ) within 5 years before Screening
23. Receiving blood transfusion or undergoing plasmapheresis within 6 months before Screening.
24. History of splenectomy.
25. Intolerance or history of hypersensitivity to insulin lispro or any excipient of the study drugs.
26. 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.
18 Years
75 Years
ALL
No
Sponsors
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Gan and Lee Pharmaceuticals, USA
INDUSTRY
Responsible Party
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Principal Investigators
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Jia Lu, PhD
Role: STUDY_DIRECTOR
Gan & Lee Pharmaceuticals, USA
Locations
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Trantor 99 Bt Anyagcsere Centrum
Budapest, , Hungary
Debreceni Egyetem Kenézy Gyula Egyetemi Kórház
Debrecen, , Hungary
Békés Megyei Központi Kórház Pándy Kálmán Tagkórház
Gyula, , Hungary
Somogy Megyei Kaposi Mór Oktató Kórház
Kaposvár, , Hungary
Kanizsai Dorottya Kórház
Nagykanizsa, , Hungary
Markusovszky Egyetemi Oktatokorhaz
Szombathely, , Hungary
Medical-Expert Kutatási - Kísérleti és Szolgáltató Kft
Veszprém, , Hungary
Zala Megyei Szent Rafael Kórház
Zalaegerszeg, , Hungary
Advanced Research Center
Anaheim, California, United States
Valley Research
Fresno, California, United States
Angel City Research, Inc.
Los Angeles, California, United States
California Medical Research Association
Northridge, California, United States
Centrum Badań Klinicznych PI-House
Gdansk, , Poland
Mills-Peninsula Health Services
San Mateo, California, United States
Care Access Research - Santa Clarita
Santa Clarita, California, United States
Metabolic Institute of America
Tarzana, California, United States
University of Colorado School of Medicine
Aurora, Colorado, United States
IMMUNOe International Research Centers - Longmont
Longmont, Colorado, United States
Chase Medical Research of Greater New Haven
Hamden, Connecticut, United States
The Center for Diabetes and Endocrine Care
Fort Lauderdale, Florida, United States
M & O Clinical Research
Fort Lauderdale, Florida, United States
Sweet Hope Research Specialty Inc.
Hialeah, Florida, United States
Homestead Associates in Research
Homestead, Florida, United States
Med Research of Florida
Miami, Florida, United States
Suncoast Clinical Research - Pasco County
New Port Richey, Florida, United States
Florida Institute for Clinical Research, LLC
Orlando, Florida, United States
Ormond Beach Clinical Research
Ormond Beach, Florida, United States
Suncoast Clinical Research - Pinellas County
Palm Harbor, Florida, United States
Meridien Research - Spring Hill
Spring Hill, Florida, United States
Metabolic Research Institute
West Palm Beach, Florida, United States
Atlanta Diabetes Associates
Atlanta, Georgia, United States
IACT Health - Columbus Regional Medical Group Endocrine Consultants - Columbus
Columbus, Georgia, United States
IACT Health - Columbus Regional Medical Group Endocrine Consultants
Newnan, Georgia, United States
Endocrine Research Solutions
Roswell, Georgia, United States
Cedar Crosse Research Center
Chicago, Illinois, United States
Midwest CRC
Crystal Lake, Illinois, United States
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, United States
Kentucky Diabetes Endocrinology Center
Lexington, Kentucky, United States
Bay West Endocrinology Associates
Baltimore, Maryland, United States
BTC Network - Capital Diabetes and Endocrine Associates - Camp Springs
Camp Springs, Maryland, United States
Endocrine & Metabolic Consultants
Rockville, Maryland, United States
Quality Clinical Research
Omaha, Nebraska, United States
Palm Research Center
Las Vegas, Nevada, United States
BTC Network - Garden State Endocrinology - Brick
Brick, New Jersey, United States
The Endocrine Group, LLP
Albany, New York, United States
North Shore Diabetes and Endocrine Associates
New Hyde Park, New York, United States
University Physicians Group
Staten Island, New York, United States
PharmQuest
Greensboro, North Carolina, United States
Physicians East - Greenville
Greenville, North Carolina, United States
Carteret Medical Group - Morehead City
Morehead City, North Carolina, United States
Endocrinology Research Associates
Columbus, Ohio, United States
Your Diabetes Endocrine Nutrition Group, Inc.
Mentor, Ohio, United States
Intend Research
Norman, Oklahoma, United States
Lynn Institute of Stillwater
Stillwater, Oklahoma, United States
Care Access Research - Warwick
Warwick, Rhode Island, United States
University Diabetes & Endocrine Consultants
Chattanooga, Tennessee, United States
Amarillo Medical Specialists
Amarillo, Texas, United States
Austin Regional Clinic
Austin, Texas, United States
Texas Diabetes & Endocrinology - Central Austin
Austin, Texas, United States
Research Institute of Dallas
Dallas, Texas, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
El Paso Medical Research Institute
El Paso, Texas, United States
Pioneer Research Solutions
Houston, Texas, United States
Austin Regional Clinic - Kelly Lane
Pflugerville, Texas, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States
Northeast Clinical Research of San Antonio
Schertz, Texas, United States
Crossroads Clinical Research
Victoria, Texas, United States
Diabetologie České Budějovice s.r.o
České Budějovice, Jihočeský kraj, Czechia
Diahaza s.r.o.
Holešov, , Czechia
StefaMed
Hradec Králové, , Czechia
Clintrial
Prague, , Czechia
Milan Kvapil s.r.o
Prague, , Czechia
Diabeteszentrum DO
Dortmund, , Germany
Diabetes Schwerpunktpraxis
Duisburg, , Germany
Diabetes-falkensee.de - Zentrum für klinische Studien
Falkensee, , Germany
RED-Institut GmbH
Oldenburg, , Germany
Diabetologische Praxis
Saarlouis, , Germany
Lausmed Egeszsegugyi es Szolgaltato Kft.
Baja, , Hungary
Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet
Budapest, , Hungary
Bajcsy-Zsilinszky Kórház és Rendelőintézet
Budapest, , Hungary
Niepubliczny Zaklad Opieki Zdrowotnej Gdanska Poradnia Cukrzycowa
Gdansk, , Poland
Centrum Medyczne Pratia Gdynia
Gdynia, , Poland
Centrum Medyczne Pratia Katowice
Katowice, , Poland
Pratia MCM Kraków
Krakow, , Poland
NZOZ Medyczne Centrum Diabetologiczno-Endokrynologiczno-Metaboliczne "Diab-Endo-Met"
Krakow, , Poland
CenterMed Lublin Sp. z o.o
Lublin, , Poland
KO-MED Centra Kliniczne Lublin - Królewska
Lublin, , Poland
Bogdan Walko Niepubliczny Zakład Opieki Zdrowotnej Przychodnia Specjalistyczna MEDICA
Lublin, , Poland
Centrum Medyczne Grunwald
Poznan, , Poland
Nasz Lekarz Przychodnie Medyczne
Torun, , Poland
AMED Centrum Medyczne
Warsaw, , Poland
Centralny Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji w Warszawie
Warsaw, , Poland
Centrum Medyczne K2J2
Wołomin, , Poland
Regionalna Poradnia Diabetologiczna
Wroclaw, , Poland
Centrum Medyczne Oporów
Wroclaw, , Poland
Complejo Hospitalario Universitario La Coruña (Gerencia de Gestión Integrada de A Coruña)
A Coruña, , Spain
Hospital de la Santa Creu i de Sant Pau
Barcelona, , Spain
Hospital Universitari Vall d'Hebrón
Barcelona, , Spain
Complejo Hospitalario Universitario de Ferrol
Ferrol, , Spain
Hospital Universitari Arnau de Vilanova
Lleida, , Spain
Hospital Universitario de La Princesa
Madrid, , Spain
Hospital Universitario Ramón Y Cajal
Madrid, , Spain
Hospital Universitario Virgen de la Victoria
Málaga, , Spain
Fundació Hospital de l'Esperit Sant
Santa Coloma de Gramenet, , Spain
Nuevas Tecnologías en Diabetes y Endocrinología
Seville, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Hospital Universitario Virgen de Valme
Seville, , Spain
Countries
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Other Identifiers
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GL-LSPT1-3003
Identifier Type: -
Identifier Source: org_study_id
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