Mylan Insulin Aspart Study
A Randomized, Multicenter, Open-Label, Parallel-Group Clinical Study Comparing the Safety and Efficacy of MYL-1601D With NovoLog® in Type 1 Diabetes Mellitus Patients
1 other identifier
interventional
478
1 country
158
Brief Summary
The aim of this phase III trial is to demonstrate the equivalence in the safety and efficacy profile between MYL-1601D and NovoLog® in patients with T1DM.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2018
Shorter than P25 for phase_3
158 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 7, 2018
CompletedFirst Submitted
Initial submission to the registry
November 21, 2018
CompletedFirst Posted
Study publicly available on registry
November 30, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 28, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 17, 2020
CompletedResults Posted
Study results publicly available
January 27, 2021
CompletedFebruary 25, 2022
February 1, 2022
1.1 years
November 21, 2018
December 8, 2020
February 23, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Treatment Emergent Antibody Response (TEAR)
The number of subjects who were TEAR positive. TEAR is defined as either one of the following: 1. Subjects who are Anti-Drug Antibody (ADA) negative at baseline and become positive at any timepoint post baseline 2. Subjects who are ADA positive at baseline and demonstrate 4-fold increase in titer values at any timepoint post baseline visit.
Baseline to week 24
Secondary Outcomes (6)
Change in HbA1c From Baseline
Baseline to week 24
Change in Fasting Plasma Glucose From Baseline
Baseline to week 24
Change in Prandial Insulin Dose From Baseline
Baseline to week 24
Change in Basal Insulin Dose From Baseline
Baseline to week 24
Change in Total Daily Insulin Dose From Baseline
Baseline to week 24
- +1 more secondary outcomes
Study Arms (2)
MYL-1601D Product (100 U/mL)
ACTIVE COMPARATORFlexPen NovoLog® (100 U/mL)
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Written and signed informed consent.
- Clinical diagnosis of type 1 diabetes mellitus for at least 6 months prior to screening.
- Subject is able and willing to comply with the requirements of the study protocol.
You may not qualify if:
- History or presence of a medical condition or disease that in the Investigator's opinion would place the subject at an unacceptable risk from study participation.
- History of hypersensitivity to any of the active or inactive ingredients of the insulin/insulin analogue preparations used in the study, OR history of significant allergic drug reactions.
- Any clinically significant abnormality in electrocardiogram or safety laboratory tests.
- Any elective surgery requiring hospitalization planned during the study period.
- History of a significant medical condition, such as unstable angina, myocardial infarction, stroke or transient ischemic attack in the 6 months before screening.
- Subjects with major depressive illness in the last 3 years.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mylan Inc.lead
- Mylan GmbHcollaborator
Study Sites (158)
Endocrinology Associates Montgomery
Montgomery, Alabama, 36106, United States
Phoenician Centers for Research
Phoenix, Arizona, 85012, United States
Precision Trials
Phoenix, Arizona, 85032, United States
Medical Investigations Inc.
Little Rock, Arkansas, 72211, United States
John Muir Physician Network
Concord, California, 94520, United States
Valley Research
Fresno, California, 93720, United States
Marin Endocrine Care & Research, Inc.
Greenbrae, California, 94904, United States
Diabetes/Lipid Management and Research Center
Huntington Beach, California, 92648, United States
Diabetes And Endocrine Associates
La Mesa, California, 91942, United States
Long Beach Center For Clinical Research
Long Beach, California, 90807, United States
Office of Richard S. Cherlin, M.D
Los Gatos, California, 95032, United States
The Rose Salter Medical Research Foundation
Newport Beach, California, 92657, United States
Providence Clinical Research
North Hollywood, California, 91606, United States
California Medical Research Associates Inc
Northridge, California, 91324, United States
Pacific Reserach Partners
Oakland, California, 94607, United States
Palmtree Clinical Research, Inc.
Palm Springs, California, 92262, United States
Western Univ of Health Science
Pomona, California, 91766, United States
Mills-Peninsula Health Services Diabetes Research Institute
San Mateo, California, 94401, United States
NorCal Endocrinology and Internal Medicine
San Ramon, California, 94583, United States
Sansum Diabetes Research Institute
Santa Barbara, California, 93105, United States
Coastal Biomedical Research, Inc.
Santa Monica, California, 90404, United States
The Metabolic Institute Of America (Mioa Inc)
Tarzana, California, 91356, United States
Diabetes Research Center
Tustin, California, 92780, United States
Dr.Ronald H. Chochinov MD,Office Of
Ventura, California, 93003, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598, United States
Barbara Davis Center for Diabetes
Aurora, Colorado, 80045, United States
Creekside Endocrine Associates, PC
Denver, Colorado, 80246, United States
New West Physicians
Golden, Colorado, 80401, United States
Paradigm Research
Wheat Ridge, Colorado, 80033, United States
Meridien Research
Bradenton, Florida, 34201, United States
Hi Tech and Global Research, LLC
Coral Gables, Florida, 33134, United States
Moonshine Research Center, Inc.
Doral, Florida, 33166, United States
Northeast Research Institute
Fleming Island, Florida, 32003, United States
Eastern Research, Inc.
Hialeah, Florida, 33013, United States
East Coast Institute for Research, LLC
Jacksonville, Florida, 32216, United States
Care Research Center, Inc
Kendall, Florida, 33175, United States
Meridien Research
Lakeland, Florida, 33805, United States
Central Florida Endocrine & Diabetes Consultants
Maitland, Florida, 32751, United States
Meridien Research
Maitland, Florida, 32751, United States
Pharmax Research Clinic, Inc.
Miami, Florida, 33126, United States
Quality Professional Healthcare
Miami, Florida, 33126, United States
Life Spring Research Foundation
Miami, Florida, 33130, United States
Cordova Research Institute
Miami, Florida, 33155, United States
DL Research Solutions Inc
Miami, Florida, 33155, United States
Baptist Diabetes Associates, Pa
Miami, Florida, 33156, United States
Medi Clear Medical & Research Center, Inc
Miami, Florida, 33165, United States
Phoenix Medical Research LLC
Miami, Florida, 33165, United States
Dr. De Armas Research Center, LLC
Miami, Florida, 33174, United States
P & S Research, LLC
Miami, Florida, 33175, United States
Inpatient Research Clinic
Miami Lakes, Florida, 33014, United States
Clinical Neurosciecne Solutions, Inc. dba CNS Healthcare
Orlando, Florida, 32806, United States
Omega Research Maitland, LLC
Orlando, Florida, 32808, United States
Ribo Research, LLC dba Peninsula Research, Inc
Ormond Beach, Florida, 32174, United States
Suncoast Clinical Research Inc.
Palm Harbor, Florida, 34684, United States
Hanson Clinical Research Center
Port Charlotte, Florida, 33952, United States
Progressive Medical Research
Port Orange, Florida, 32127, United States
Meridien Research
Spring Hill, Florida, 34609, United States
Meridien Research
St. Petersburg, Florida, 33709, United States
Meridien Research
Tampa, Florida, 33634, United States
Asclepes Research Centers
Weeki Wachee, Florida, 34607, United States
Metabolic Research Institute, Inc.
West Palm Beach, Florida, 33401, United States
Atlanta Diabetes Associates
Atlanta, Georgia, 30318, United States
IACT Health
Columbus, Georgia, 31904, United States
Physicians Research Associates, LLC
Lawrenceville, Georgia, 30046, United States
The Jones Center for Diabetes and Endrocrine Wellness
Macon, Georgia, 31210, United States
In-Quest Medical Research, LLC
Peachtree Corners, Georgia, 30071, United States
Endocrine Research Solutions, Inc.
Roswell, Georgia, 30076, United States
Rocky Mountain Diabetes And Osteoporosis Center
Idaho Falls, Idaho, 83404, United States
Advanced Clinical Research
Meridian, Idaho, 83642, United States
Northwest Endo Diabets Res.LLC
Arlington Heights, Illinois, 60005, United States
Midwest Endocrinology
Crystal Lake, Illinois, 60012, United States
NorthShore University Health System
Skokie, Illinois, 60077, United States
American Research, LLC
Jeffersonville, Indiana, 47130, United States
West Broadway Clinic
Council Bluffs, Iowa, 51501, United States
Iowa Diabetes and Endocrinology Research Center (IDERC)
West Des Moines, Iowa, 50265, United States
Overland Park Surgical Specialties, LLC d/b/a College Park Family Care Center Physicians Group
Overland Park, Kansas, 66210, United States
Cotton O'Neil Clinical Research Ctr
Topeka, Kansas, 66606, United States
Veterans Affairs Medical Center
Lexington, Kentucky, 40502, United States
Kentucky Diabetes And Endocrinology Center
Lexington, Kentucky, 40503, United States
Crescent City Clinical Research Center, LLC
Metairie, Louisiana, 70006, United States
Model Clinical Research
Baltimore, Maryland, 21204, United States
Boston University School Of Medicine
Boston, Massachusetts, 02118, United States
MassResearch
Waltham, Massachusetts, 02453, United States
Elite Clinical Research
Flint, Michigan, 48532, United States
Professional Clinical Research
Traverse City, Michigan, 49686, United States
Diabetes & Endocrinology Specialists, Inc.
Chesterfield, Missouri, 63017, United States
Jefferson City Medical Group (Jcmg) - Jcmg Medical Building
Jefferson City, Missouri, 65109, United States
Mercy Research
Springfield, Missouri, 65807, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Billings Clinic Research Center
Billings, Montana, 59101, United States
Mercury Street Medical Group, PLLC
Butte, Montana, 59701, United States
Glacier View Research Institute - Endocrinology
Kalispell, Montana, 59901, United States
Diabetes & Endocrine Associates, PC Research Center
Omaha, Nebraska, 68114, United States
Alegent Health Research Center
Omaha, Nebraska, 68124, United States
Palm Research Center, Inc.
Las Vegas, Nevada, 89148, United States
Northern Nevada Endocrinology
Reno, Nevada, 89519, United States
Southern New Hampshire Diabetes and Endocrinology
Nashua, New Hampshire, 03063, United States
Albany Medical College
Albany, New York, 12206, United States
NY Scientific
Brooklyn, New York, 11235, United States
Northwell Health
Great Neck, New York, 11021, United States
Scott Research,Inc
Laurelton, New York, 11413, United States
Winthrop-University Hospital, Clinical Trials Center
Mineola, New York, 11501, United States
North Shore Diabetes and Endocrine Associates
New Hyde Park, New York, 11042, United States
Endocrine Associates of West Village
New York, New York, 10001, United States
Manhattan Medical Research Practice
New York, New York, 10016, United States
Dr. Jonas Leibowitz MD, Office Of
Yonkers, New York, 10704, United States
Mountain Diabetes
Asheville, North Carolina, 28803, United States
Medication Management, LLC
Greensboro, North Carolina, 27408, United States
Physician's East, PA
Greenville, North Carolina, 27834, United States
Carteret Medical Group
Morehead City, North Carolina, 28557, United States
Lucas Research, Inc.
Morehead City, North Carolina, 28857, United States
Medication Management, LLC
Raleigh, North Carolina, 27609, United States
PMG Research of Wilmington, LLC
Wilmington, North Carolina, 28401, United States
Lillestol Research LLC
Fargo, North Dakota, 58104, United States
Diabetes & Endocrinology Associates of Stark County Inc
Canton, Ohio, 44718, United States
Sterling Research Group, Ltd
Cincinnati, Ohio, 45246, United States
Rapid Medical Research, Inc.
Cleveland, Ohio, 44122, United States
Intend Clinical Research
Norman, Oklahoma, 73069, United States
Lynn Institute of Norman
Norman, Oklahoma, 73069, United States
Endocrinology Service Northwest LLC - Bend; Advanced Specialty Care (ASC) - Bend Office
Bend, Oregon, 97702, United States
Care Access Research, Warwick
Warwick, Rhode Island, 02886, United States
Mountain View Clinical Research, Inc.
Greer, South Carolina, 29651, United States
Carolina Health Specialist
Myrtle Beach, South Carolina, 29572, United States
Meridian Clinical Research
Dakota Dunes, South Dakota, 57049, United States
Holston Medical Group
Bristol, Tennessee, 37620, United States
University Diabetes & Endocrine Consultants
Chattanooga, Tennessee, 37411, United States
WR Clinsearch, LLC
Chattanooga, Tennessee, 37421, United States
Omega Research Nashville, LLC
Nashville, Tennessee, 37211, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37212, United States
Amarillo Medical Specialists
Amarillo, Texas, 79106, United States
Texas Diabetes & Endocrinology
Austin, Texas, 78731, United States
North Texas Endocrine Center
Dallas, Texas, 75231, United States
Research Institute of Dallas
Dallas, Texas, 75231, United States
Baylor Research Institute
Dallas, Texas, 75246, United States
UT Southwestern Medical Center Division of Endocrinology
Dallas, Texas, 75390, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
Academy of Diabetes Thyroid and Endocrine
El Paso, Texas, 79935, United States
Diabetes and Thyroid Center of Fort Worth
Fort Worth, Texas, 76132, United States
Victorium Clinical Research
Houston, Texas, 77024, United States
Juno Research, LLC
Houston, Texas, 77040, United States
Endocrine IPS, PLLC
Houston, Texas, 77079, United States
Clinova Clinical Trials
Houston, Texas, 77082, United States
Biopharma Informatic, LLC
Houston, Texas, 77084, United States
Dr.Amir Ali Hassan, MD Off of
Houston, Texas, 77089, United States
North Hills Medical Research, Inc.
North Richland Hills, Texas, 76180, United States
Clinical Trials of Texas, Inc
San Antonio, Texas, 78229, United States
Science Advancing Medicine (Sam) Clinical Research
San Antonio, Texas, 78229, United States
Victorium Clinical Research
San Antonio, Texas, 78230, United States
Northeast Clinical Research, LLC
Schertz, Texas, 78154, United States
Consano Clinical Research
Shavano Park, Texas, 78231, United States
DM Clinical Research
Tomball, Texas, 77375, United States
Bay Area Metabolic Health
Webster, Texas, 77598, United States
Wasatch Clinical Research,LLC
Salt Lake City, Utah, 84107, United States
Dr.David Gorson Md, Office Of
Bennington, Vermont, 05201, United States
Manassas Clinical Research Center
Manassas, Virginia, 20110, United States
Dr. Larry D. Stonesifer,MD,Office Of
Federal Way, Washington, 98003, United States
Multicare Health System Research Institute
Spokane, Washington, 99202, United States
The Vancouver Clinic, Inc. PS
Vancouver, Washington, 98664, United States
Related Publications (1)
Blevins TC, Raiter Y, Sun B, Donnelly C, Shapiro R, Chullikana A, Rao A, Vashishta L, Ranganna G, Barve A. Immunogenicity, Efficacy, and Safety of Biosimilar Insulin Aspart (MYL-1601D) Compared with Originator Insulin Aspart (Novolog(R)) in Patients with Type 1 Diabetes After 24 Weeks: A Randomized Open-Label Study. BioDrugs. 2022 Nov;36(6):761-772. doi: 10.1007/s40259-022-00554-6. Epub 2022 Sep 17.
PMID: 36114990DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Keri L. Vaughan
- Organization
- Sr. Director Global Clinical Operations, General Medicine
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 21, 2018
First Posted
November 30, 2018
Study Start
November 7, 2018
Primary Completion
December 28, 2019
Study Completion
January 17, 2020
Last Updated
February 25, 2022
Results First Posted
January 27, 2021
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share