Gan & Lee Evaluation of New Biosimilar for Type 1 Lispro

NCT04254380 | Withdrawn Phase 3 FDA Drug

• 1 other identifier: GL-LSPT1-3003
• Study Type: interventional
• Target: N/A
• Locations: 6 countries
• Sites: 107

Brief 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

Keywords

Diabetes; Diabetes Type 1; Type 1; Basal; Insulin; Lispro; T1DM; Diabetes Mellitus; Insulin Dependent Diabetes

Outcome Measures

Primary Outcomes (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.

  Week 1 to Week 26

Secondary Outcomes (8)

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

  Week 1 to Week 26

• Percentage of subjects with important increase in titers

  Week 1 to Week 26

• Mean change from baseline in AIA titers

  Week 1 to Week 26

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

  Week 1 to Week 26

• Percentage of subjects with positive AIA after baseline

  Week 1 to Week 26

Study Arms (2)

Experimental: Gan & Lee Insulin Lispro Injection

EXPERIMENTAL

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.

Biological: Gan & Lee Insulin Lispro Injection

Active Comparator: Humalog

ACTIVE COMPARATOR

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.

Biological: Humalog

Interventions

Gan & Lee Insulin Lispro Injection BIOLOGICAL

Route of administration: subcutaneous injection

Experimental: Gan & Lee Insulin Lispro Injection

Humalog BIOLOGICAL

Route of administration: subcutaneous injection

Active Comparator: Humalog

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Gan and Lee Pharmaceuticals, USA: lead

Study Sites (107)

Advanced Research Center

Anaheim, California, 92805, United States

Location

Valley Research

Fresno, California, 93720, United States

Location

Angel City Research, Inc.

Los Angeles, California, 90057, United States

Location

California Medical Research Association

Northridge, California, 91324, United States

Location

Mills-Peninsula Health Services

San Mateo, California, 94401, United States

Location

Care Access Research - Santa Clarita

Santa Clarita, California, 91321, United States

Location

Metabolic Institute of America

Tarzana, California, 91356, United States

Location

University of Colorado School of Medicine

Aurora, Colorado, 80045, United States

Location

IMMUNOe International Research Centers - Longmont

Longmont, Colorado, 80501, United States

Location

Chase Medical Research of Greater New Haven

Hamden, Connecticut, 06517, United States

Location

The Center for Diabetes and Endocrine Care

Fort Lauderdale, Florida, 33312, United States

Location

M & O Clinical Research

Fort Lauderdale, Florida, 33316, United States

Location

Sweet Hope Research Specialty Inc.

Hialeah, Florida, 33016, United States

Location

Homestead Associates in Research

Homestead, Florida, 33032, United States

Location

Med Research of Florida

Miami, Florida, 33186, United States

Location

Suncoast Clinical Research - Pasco County

New Port Richey, Florida, 34652, United States

Location

Florida Institute for Clinical Research, LLC

Orlando, Florida, 32825, United States

Location

Ormond Beach Clinical Research

Ormond Beach, Florida, 32174, United States

Location

Suncoast Clinical Research - Pinellas County

Palm Harbor, Florida, 34684, United States

Location

Meridien Research - Spring Hill

Spring Hill, Florida, 34609, United States

Location

Metabolic Research Institute

West Palm Beach, Florida, 33401, United States

Location

Atlanta Diabetes Associates

Atlanta, Georgia, 30318, United States

Location

IACT Health - Columbus Regional Medical Group Endocrine Consultants - Columbus

Columbus, Georgia, 31904, United States

Location

IACT Health - Columbus Regional Medical Group Endocrine Consultants

Newnan, Georgia, 30265, United States

Location

Endocrine Research Solutions

Roswell, Georgia, 30076, United States

Location

Cedar Crosse Research Center

Chicago, Illinois, 60607, United States

Location

Midwest CRC

Crystal Lake, Illinois, 60012, United States

Location

Iowa Diabetes and Endocrinology Research Center

West Des Moines, Iowa, 50265, United States

Location

Kentucky Diabetes Endocrinology Center

Lexington, Kentucky, 40503, United States

Location

Bay West Endocrinology Associates

Baltimore, Maryland, 21204, United States

Location

BTC Network - Capital Diabetes and Endocrine Associates - Camp Springs

Camp Springs, Maryland, 20746, United States

Location

Endocrine & Metabolic Consultants

Rockville, Maryland, 20852, United States

Location

Quality Clinical Research

Omaha, Nebraska, 68134, United States

Location

Palm Research Center

Las Vegas, Nevada, 89148, United States

Location

BTC Network - Garden State Endocrinology - Brick

Brick, New Jersey, 08723, United States

Location

The Endocrine Group, LLP

Albany, New York, 12206, United States

Location

North Shore Diabetes and Endocrine Associates

New Hyde Park, New York, 11042, United States

Location

University Physicians Group

Staten Island, New York, 10301, United States

Location

PharmQuest

Greensboro, North Carolina, 27408, United States

Location

Physicians East - Greenville

Greenville, North Carolina, 27834, United States

Location

Carteret Medical Group - Morehead City

Morehead City, North Carolina, 28557, United States

Location

Endocrinology Research Associates

Columbus, Ohio, 43201, United States

Location

Your Diabetes Endocrine Nutrition Group, Inc.

Mentor, Ohio, 44060, United States

Location

Intend Research

Norman, Oklahoma, 73069, United States

Location

Lynn Institute of Stillwater

Stillwater, Oklahoma, 73111, United States

Location

Care Access Research - Warwick

Warwick, Rhode Island, 02886, United States

Location

University Diabetes & Endocrine Consultants

Chattanooga, Tennessee, 37411, United States

Location

Amarillo Medical Specialists

Amarillo, Texas, 79106, United States

Location

Austin Regional Clinic

Austin, Texas, 78704, United States

Location

Texas Diabetes & Endocrinology - Central Austin

Austin, Texas, 78731, United States

Location

Research Institute of Dallas

Dallas, Texas, 75231, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

El Paso Medical Research Institute

El Paso, Texas, 79935, United States

Location

Pioneer Research Solutions

Houston, Texas, 77099, United States

Location

Austin Regional Clinic - Kelly Lane

Pflugerville, Texas, 78660, United States

Location

Clinical Trials of Texas, Inc.

San Antonio, Texas, 78229, United States

Location

Northeast Clinical Research of San Antonio

Schertz, Texas, 78154, United States

Location

Crossroads Clinical Research

Victoria, Texas, 77901, United States

Location

Diabetologie České Budějovice s.r.o

České Budějovice, Jihočeský kraj, 370 01, Czechia

Location

Diahaza s.r.o.

Holešov, 769 01, Czechia

Location

StefaMed

Hradec Králové, 503 41, Czechia

Location

Clintrial

Prague, 100 00, Czechia

Location

Milan Kvapil s.r.o

Prague, 149 00, Czechia

Location

Diabeteszentrum DO

Dortmund, 44137, Germany

Location

Diabetes Schwerpunktpraxis

Duisburg, 47051, Germany

Location

Diabetes-falkensee.de - Zentrum für klinische Studien

Falkensee, 14612, Germany

Location

RED-Institut GmbH

Oldenburg, 23758, Germany

Location

Diabetologische Praxis

Saarlouis, 66740, Germany

Location

Lausmed Egeszsegugyi es Szolgaltato Kft.

Baja, 6500, Hungary

Location

Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet

Budapest, 1097, Hungary

Location

Bajcsy-Zsilinszky Kórház és Rendelőintézet

Budapest, 1106, Hungary

Location

Trantor 99 Bt Anyagcsere Centrum

Budapest, 1213, Hungary

Location

Debreceni Egyetem Kenézy Gyula Egyetemi Kórház

Debrecen, 4031, Hungary

Location

Békés Megyei Központi Kórház Pándy Kálmán Tagkórház

Gyula, 5700, Hungary

Location

Somogy Megyei Kaposi Mór Oktató Kórház

Kaposvár, 7400, Hungary

Location

Kanizsai Dorottya Kórház

Nagykanizsa, 8801, Hungary

Location

Markusovszky Egyetemi Oktatokorhaz

Szombathely, 9700, Hungary

Location

Medical-Expert Kutatási - Kísérleti és Szolgáltató Kft

Veszprém, 8200, Hungary

Location

Zala Megyei Szent Rafael Kórház

Zalaegerszeg, 8900, Hungary

Location

Centrum Badań Klinicznych PI-House

Gdansk, 80-546, Poland

Location

Niepubliczny Zaklad Opieki Zdrowotnej Gdanska Poradnia Cukrzycowa

Gdansk, 80-858, Poland

Location

Centrum Medyczne Pratia Gdynia

Gdynia, 81-338, Poland

Location

Centrum Medyczne Pratia Katowice

Katowice, 40-081, Poland

Location

Pratia MCM Kraków

Krakow, 30-510, Poland

Location

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

Krakow, 31-261, Poland

Location

CenterMed Lublin Sp. z o.o

Lublin, 20 044, Poland

Location

KO-MED Centra Kliniczne Lublin - Królewska

Lublin, 20-109, Poland

Location

Bogdan Walko Niepubliczny Zakład Opieki Zdrowotnej Przychodnia Specjalistyczna MEDICA

Lublin, 20-538, Poland

Location

Centrum Medyczne Grunwald

Poznan, 60-369, Poland

Location

Nasz Lekarz Przychodnie Medyczne

Torun, 87-100, Poland

Location

AMED Centrum Medyczne

Warsaw, 01-518, Poland

Location

Centralny Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji w Warszawie

Warsaw, 02-507, Poland

Location

Centrum Medyczne K2J2

Wołomin, 05-230, Poland

Location

Regionalna Poradnia Diabetologiczna

Wroclaw, 50-127, Poland

Location

Centrum Medyczne Oporów

Wroclaw, 52-416, Poland

Location

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

A Coruña, 15006, Spain

Location

Hospital de la Santa Creu i de Sant Pau

Barcelona, 8025, Spain

Location

Hospital Universitari Vall d'Hebrón

Barcelona, 8035, Spain

Location

Complejo Hospitalario Universitario de Ferrol

Ferrol, 15405, Spain

Location

Hospital Universitari Arnau de Vilanova

Lleida, 25198, Spain

Location

Hospital Universitario de La Princesa

Madrid, 28006, Spain

Location

Hospital Universitario Ramón Y Cajal

Madrid, 28034, Spain

Location

Hospital Universitario Virgen de la Victoria

Málaga, 29006, Spain

Location

Fundació Hospital de l'Esperit Sant

Santa Coloma de Gramenet, 8923, Spain

Location

Nuevas Tecnologías en Diabetes y Endocrinología

Seville, 41003, Spain

Location

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

Location

Hospital Universitario Virgen de Valme

Seville, 41014, Spain

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus; Insulin Resistance

Interventions

gallium nitrate; Insulin Lispro

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Jia Lu, PhD

  Gan & Lee Pharmaceuticals, USA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 13, 2020
• First Posted: February 5, 2020
• Study Start: December 4, 2019
• Primary Completion: January 27, 2020
• Study Completion: January 27, 2020
• Last Updated: February 5, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (58); PL (16); DE (5); CZ (5); HU (11); ES (12)