Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
478 participants
INTERVENTIONAL
2018-11-07
2020-01-17
Brief Summary
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Detailed Description
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After up to 3-week screening period, all subjects will be titrated on NovoLog® during a 4-week run-in period, and will be shifted from their current basal insulin to study insulin Lantus®. After run-in period, subjects will be randomized; one group will receive MYL-1601D, while the other group will receive NovoLog® for 24 weeks. A follow-up visit, via telephone call, will be scheduled 4 weeks after last dose of MYL-1601D.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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MYL-1601D Product (100 U/mL)
MYL-1601D Product
(100 U/mL)
FlexPen NovoLog® (100 U/mL)
FlexPen NovoLog®
(100 U/mL)
Interventions
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MYL-1601D Product
(100 U/mL)
FlexPen NovoLog®
(100 U/mL)
Eligibility Criteria
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Inclusion Criteria
2. Clinical diagnosis of type 1 diabetes mellitus for at least 6 months prior to screening.
3. Subject is able and willing to comply with the requirements of the study protocol.
Exclusion Criteria
2. 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.
3. Any clinically significant abnormality in electrocardiogram or safety laboratory tests.
4. Any elective surgery requiring hospitalization planned during the study period.
5. History of a significant medical condition, such as unstable angina, myocardial infarction, stroke or transient ischemic attack in the 6 months before screening.
6. 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
18 Years
65 Years
ALL
No
Sponsors
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Mylan GmbH
INDUSTRY
Mylan Inc.
INDUSTRY
Responsible Party
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Locations
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Albany Medical College
Albany, New York, United States
NY Scientific
Brooklyn, New York, United States
Northwell Health
Great Neck, New York, United States
Scott Research,Inc
Laurelton, New York, United States
Endocrinology Associates Montgomery
Montgomery, Alabama, United States
Phoenician Centers for Research
Phoenix, Arizona, United States
Precision Trials
Phoenix, Arizona, United States
Medical Investigations Inc.
Little Rock, Arkansas, United States
John Muir Physician Network
Concord, California, United States
Valley Research
Fresno, California, United States
Marin Endocrine Care & Research, Inc.
Greenbrae, California, United States
Diabetes/Lipid Management and Research Center
Huntington Beach, California, United States
Diabetes And Endocrine Associates
La Mesa, California, United States
Long Beach Center For Clinical Research
Long Beach, California, United States
Office of Richard S. Cherlin, M.D
Los Gatos, California, United States
The Rose Salter Medical Research Foundation
Newport Beach, California, United States
Providence Clinical Research
North Hollywood, California, United States
California Medical Research Associates Inc
Northridge, California, United States
Pacific Reserach Partners
Oakland, California, United States
Palmtree Clinical Research, Inc.
Palm Springs, California, United States
Western Univ of Health Science
Pomona, California, United States
Mills-Peninsula Health Services Diabetes Research Institute
San Mateo, California, United States
NorCal Endocrinology and Internal Medicine
San Ramon, California, United States
Sansum Diabetes Research Institute
Santa Barbara, California, United States
Coastal Biomedical Research, Inc.
Santa Monica, California, United States
The Metabolic Institute Of America (Mioa Inc)
Tarzana, California, United States
Diabetes Research Center
Tustin, California, United States
Dr.Ronald H. Chochinov MD,Office Of
Ventura, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
Barbara Davis Center for Diabetes
Aurora, Colorado, United States
Creekside Endocrine Associates, PC
Denver, Colorado, United States
New West Physicians
Golden, Colorado, United States
Paradigm Research
Wheat Ridge, Colorado, United States
Meridien Research
Bradenton, Florida, United States
Hi Tech and Global Research, LLC
Coral Gables, Florida, United States
Moonshine Research Center, Inc.
Doral, Florida, United States
Northeast Research Institute
Fleming Island, Florida, United States
Eastern Research, Inc.
Hialeah, Florida, United States
East Coast Institute for Research, LLC
Jacksonville, Florida, United States
Care Research Center, Inc
Kendall, Florida, United States
Meridien Research
Lakeland, Florida, United States
Central Florida Endocrine & Diabetes Consultants
Maitland, Florida, United States
Meridien Research
Maitland, Florida, United States
Pharmax Research Clinic, Inc.
Miami, Florida, United States
Quality Professional Healthcare
Miami, Florida, United States
Life Spring Research Foundation
Miami, Florida, United States
Cordova Research Institute
Miami, Florida, United States
DL Research Solutions Inc
Miami, Florida, United States
Baptist Diabetes Associates, Pa
Miami, Florida, United States
Medi Clear Medical & Research Center, Inc
Miami, Florida, United States
Phoenix Medical Research LLC
Miami, Florida, United States
Dr. De Armas Research Center, LLC
Miami, Florida, United States
P & S Research, LLC
Miami, Florida, United States
Inpatient Research Clinic
Miami Lakes, Florida, United States
Clinical Neurosciecne Solutions, Inc. dba CNS Healthcare
Orlando, Florida, United States
Omega Research Maitland, LLC
Orlando, Florida, United States
Ribo Research, LLC dba Peninsula Research, Inc
Ormond Beach, Florida, United States
Suncoast Clinical Research Inc.
Palm Harbor, Florida, United States
Hanson Clinical Research Center
Port Charlotte, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
Meridien Research
Spring Hill, Florida, United States
Meridien Research
St. Petersburg, Florida, United States
Meridien Research
Tampa, Florida, United States
Asclepes Research Centers
Weeki Wachee, Florida, United States
Metabolic Research Institute, Inc.
West Palm Beach, Florida, United States
Atlanta Diabetes Associates
Atlanta, Georgia, United States
IACT Health
Columbus, Georgia, United States
Physicians Research Associates, LLC
Lawrenceville, Georgia, United States
The Jones Center for Diabetes and Endrocrine Wellness
Macon, Georgia, United States
In-Quest Medical Research, LLC
Peachtree Corners, Georgia, United States
Endocrine Research Solutions, Inc.
Roswell, Georgia, United States
Rocky Mountain Diabetes And Osteoporosis Center
Idaho Falls, Idaho, United States
Advanced Clinical Research
Meridian, Idaho, United States
Northwest Endo Diabets Res.LLC
Arlington Heights, Illinois, United States
Midwest Endocrinology
Crystal Lake, Illinois, United States
NorthShore University Health System
Skokie, Illinois, United States
American Research, LLC
Jeffersonville, Indiana, United States
West Broadway Clinic
Council Bluffs, Iowa, United States
Iowa Diabetes and Endocrinology Research Center (IDERC)
West Des Moines, Iowa, United States
Overland Park Surgical Specialties, LLC d/b/a College Park Family Care Center Physicians Group
Overland Park, Kansas, United States
Cotton O'Neil Clinical Research Ctr
Topeka, Kansas, United States
Veterans Affairs Medical Center
Lexington, Kentucky, United States
Kentucky Diabetes And Endocrinology Center
Lexington, Kentucky, United States
Crescent City Clinical Research Center, LLC
Metairie, Louisiana, United States
Model Clinical Research
Baltimore, Maryland, United States
Boston University School Of Medicine
Boston, Massachusetts, United States
MassResearch
Waltham, Massachusetts, United States
Elite Clinical Research
Flint, Michigan, United States
Professional Clinical Research
Traverse City, Michigan, United States
Diabetes & Endocrinology Specialists, Inc.
Chesterfield, Missouri, United States
Jefferson City Medical Group (Jcmg) - Jcmg Medical Building
Jefferson City, Missouri, United States
Mercy Research
Springfield, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Billings Clinic Research Center
Billings, Montana, United States
Mercury Street Medical Group, PLLC
Butte, Montana, United States
Glacier View Research Institute - Endocrinology
Kalispell, Montana, United States
Diabetes & Endocrine Associates, PC Research Center
Omaha, Nebraska, United States
Alegent Health Research Center
Omaha, Nebraska, United States
Palm Research Center, Inc.
Las Vegas, Nevada, United States
Northern Nevada Endocrinology
Reno, Nevada, United States
Southern New Hampshire Diabetes and Endocrinology
Nashua, New Hampshire, United States
Winthrop-University Hospital, Clinical Trials Center
Mineola, New York, United States
North Shore Diabetes and Endocrine Associates
New Hyde Park, New York, United States
Endocrine Associates of West Village
New York, New York, United States
Manhattan Medical Research Practice
New York, New York, United States
Dr. Jonas Leibowitz MD, Office Of
Yonkers, New York, United States
Mountain Diabetes
Asheville, North Carolina, United States
Medication Management, LLC
Greensboro, North Carolina, United States
Physician's East, PA
Greenville, North Carolina, United States
Carteret Medical Group
Morehead City, North Carolina, United States
Lucas Research, Inc.
Morehead City, North Carolina, United States
Medication Management, LLC
Raleigh, North Carolina, United States
PMG Research of Wilmington, LLC
Wilmington, North Carolina, United States
Lillestol Research LLC
Fargo, North Dakota, United States
Diabetes & Endocrinology Associates of Stark County Inc
Canton, Ohio, United States
Sterling Research Group, Ltd
Cincinnati, Ohio, United States
Rapid Medical Research, Inc.
Cleveland, Ohio, United States
Intend Clinical Research
Norman, Oklahoma, United States
Lynn Institute of Norman
Norman, Oklahoma, United States
Endocrinology Service Northwest LLC - Bend; Advanced Specialty Care (ASC) - Bend Office
Bend, Oregon, United States
Care Access Research, Warwick
Warwick, Rhode Island, United States
Mountain View Clinical Research, Inc.
Greer, South Carolina, United States
Carolina Health Specialist
Myrtle Beach, South Carolina, United States
Meridian Clinical Research
Dakota Dunes, South Dakota, United States
Holston Medical Group
Bristol, Tennessee, United States
University Diabetes & Endocrine Consultants
Chattanooga, Tennessee, United States
WR Clinsearch, LLC
Chattanooga, Tennessee, United States
Omega Research Nashville, LLC
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Amarillo Medical Specialists
Amarillo, Texas, United States
Texas Diabetes & Endocrinology
Austin, Texas, United States
North Texas Endocrine Center
Dallas, Texas, United States
Research Institute of Dallas
Dallas, Texas, United States
Baylor Research Institute
Dallas, Texas, United States
UT Southwestern Medical Center Division of Endocrinology
Dallas, Texas, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Academy of Diabetes Thyroid and Endocrine
El Paso, Texas, United States
Diabetes and Thyroid Center of Fort Worth
Fort Worth, Texas, United States
Victorium Clinical Research
Houston, Texas, United States
Juno Research, LLC
Houston, Texas, United States
Endocrine IPS, PLLC
Houston, Texas, United States
Clinova Clinical Trials
Houston, Texas, United States
Biopharma Informatic, LLC
Houston, Texas, United States
Dr.Amir Ali Hassan, MD Off of
Houston, Texas, United States
North Hills Medical Research, Inc.
North Richland Hills, Texas, United States
Clinical Trials of Texas, Inc
San Antonio, Texas, United States
Science Advancing Medicine (Sam) Clinical Research
San Antonio, Texas, United States
Victorium Clinical Research
San Antonio, Texas, United States
Northeast Clinical Research, LLC
Schertz, Texas, United States
Consano Clinical Research
Shavano Park, Texas, United States
DM Clinical Research
Tomball, Texas, United States
Bay Area Metabolic Health
Webster, Texas, United States
Wasatch Clinical Research,LLC
Salt Lake City, Utah, United States
Dr.David Gorson Md, Office Of
Bennington, Vermont, United States
Manassas Clinical Research Center
Manassas, Virginia, United States
Dr. Larry D. Stonesifer,MD,Office Of
Federal Way, Washington, United States
Multicare Health System Research Institute
Spokane, Washington, United States
The Vancouver Clinic, Inc. PS
Vancouver, Washington, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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MYL-1601D-3001
Identifier Type: -
Identifier Source: org_study_id
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