Clinical trial NCT03760068: Mylan Insulin Aspart Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: Viatris Inc.
Sponsor class: INDUSTRY
Collaborators: name: Mylan GmbH
First posted: 2018-11-30
Enrollment: 478
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: This is a multicenter, open-label, randomized, parallel-group phase 3 study in subjects with T1DM comparing the safety and efficacy of MYL-1601D with NovoLog®.

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.

Eligibility criteria: Inclusion criteria

1. Written and signed informed consent.
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

1. 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.
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

Primary outcomes:
measure: Treatment Emergent Antibody Response (TEAR)
timeFrame: Baseline to week 24
Secondary outcomes:
measure: Change in HbA1c From Baseline
timeFrame: Baseline to week 24
measure: Change in Fasting Plasma Glucose From Baseline
timeFrame: Baseline to week 24
measure: Change in Prandial Insulin Dose From Baseline
timeFrame: Baseline to week 24
measure: Change in Basal Insulin Dose From Baseline
timeFrame: Baseline to week 24
measure: Change in Total Daily Insulin Dose From Baseline
timeFrame: Baseline to week 24
measure: Change in 7-point Self-monitored Blood Glucose (SMBG) Profile From Baseline
timeFrame: Baseline to week 24
Other outcomes:
Locations:
city: Montgomery
country: United States
facility: Endocrinology Associates Montgomery
state: Alabama
city: Phoenix
country: United States
facility: Phoenician Centers for Research
state: Arizona
city: Phoenix
country: United States
facility: Precision Trials
state: Arizona
city: Little Rock
country: United States
facility: Medical Investigations Inc.
state: Arkansas
city: Concord
country: United States
facility: John Muir Physician Network
state: California
city: Fresno
country: United States
facility: Valley Research
state: California
city: Greenbrae
country: United States
facility: Marin Endocrine Care & Research, Inc.
state: California
city: Huntington Beach
country: United States
facility: Diabetes/Lipid Management and Research Center
state: California
city: La Mesa
country: United States
facility: Diabetes And Endocrine Associates
state: California
city: Long Beach
country: United States
facility: Long Beach Center For Clinical Research
state: California
city: Los Gatos
country: United States
facility: Office of Richard S. Cherlin, M.D
state: California
city: Newport Beach
country: United States
facility: The Rose Salter Medical Research Foundation
state: California
city: North Hollywood
country: United States
facility: Providence Clinical Research
state: California
city: Northridge
country: United States
facility: California Medical Research Associates Inc
state: California
city: Oakland
country: United States
facility: Pacific Reserach Partners
state: California
city: Palm Springs
country: United States
facility: Palmtree Clinical Research, Inc.
state: California
city: Pomona
country: United States
facility: Western Univ of Health Science
state: California
city: San Mateo
country: United States
facility: Mills-Peninsula Health Services Diabetes Research Institute
state: California
city: San Ramon
country: United States
facility: NorCal Endocrinology and Internal Medicine
state: California
city: Santa Barbara
country: United States
facility: Sansum Diabetes Research Institute
state: California
city: Santa Monica
country: United States
facility: Coastal Biomedical Research, Inc.
state: California
city: Tarzana
country: United States
facility: The Metabolic Institute Of America (Mioa Inc)
state: California
city: Tustin
country: United States
facility: Diabetes Research Center
state: California
city: Ventura
country: United States
facility: Dr.Ronald H. Chochinov MD,Office Of
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc.
state: California
city: Aurora
country: United States
facility: Barbara Davis Center for Diabetes
state: Colorado
city: Denver
country: United States
facility: Creekside Endocrine Associates, PC
state: Colorado
city: Golden
country: United States
facility: New West Physicians
state: Colorado
city: Wheat Ridge
country: United States
facility: Paradigm Research
state: Colorado
city: Bradenton
country: United States
facility: Meridien Research
state: Florida
city: Coral Gables
country: United States
facility: Hi Tech and Global Research, LLC
state: Florida
city: Doral
country: United States
facility: Moonshine Research Center, Inc.
state: Florida
city: Fleming Island
country: United States
facility: Northeast Research Institute
state: Florida
city: Hialeah
country: United States
facility: Eastern Research, Inc.
state: Florida
city: Jacksonville
country: United States
facility: East Coast Institute for Research, LLC
state: Florida
city: Kendall
country: United States
facility: Care Research Center, Inc
state: Florida
city: Lakeland
country: United States
facility: Meridien Research
state: Florida
city: Maitland
country: United States
facility: Central Florida Endocrine & Diabetes Consultants
state: Florida
city: Maitland
country: United States
facility: Meridien Research
state: Florida
city: Miami Lakes
country: United States
facility: Inpatient Research Clinic
state: Florida
city: Miami
country: United States
facility: Pharmax Research Clinic, Inc.
state: Florida
city: Miami
country: United States
facility: Quality Professional Healthcare
state: Florida
city: Miami
country: United States
facility: Life Spring Research Foundation
state: Florida
city: Miami
country: United States
facility: Cordova Research Institute
state: Florida
city: Miami
country: United States
facility: DL Research Solutions Inc
state: Florida
city: Miami
country: United States
facility: Baptist Diabetes Associates, Pa
state: Florida
city: Miami
country: United States
facility: Medi Clear Medical & Research Center, Inc
state: Florida
city: Miami
country: United States
facility: Phoenix Medical Research LLC
state: Florida
city: Miami
country: United States
facility: Dr. De Armas Research Center, LLC
state: Florida
city: Miami
country: United States
facility: P & S Research, LLC
state: Florida
city: Orlando
country: United States
facility: Clinical Neurosciecne Solutions, Inc. dba CNS Healthcare
state: Florida
city: Orlando
country: United States
facility: Omega Research Maitland, LLC
state: Florida
city: Ormond Beach
country: United States
facility: Ribo Research, LLC dba Peninsula Research, Inc
state: Florida
city: Palm Harbor
country: United States
facility: Suncoast Clinical Research Inc.
state: Florida
city: Port Charlotte
country: United States
facility: Hanson Clinical Research Center
state: Florida
city: Port Orange
country: United States
facility: Progressive Medical Research
state: Florida
city: Saint Petersburg
country: United States
facility: Meridien Research
state: Florida
city: Spring Hill
country: United States
facility: Meridien Research
state: Florida
city: Tampa
country: United States
facility: Meridien Research
state: Florida
city: Weeki Wachee
country: United States
facility: Asclepes Research Centers
state: Florida
city: West Palm Beach
country: United States
facility: Metabolic Research Institute, Inc.
state: Florida
city: Atlanta
country: United States
facility: Atlanta Diabetes Associates
state: Georgia
city: Columbus
country: United States
facility: IACT Health
state: Georgia
city: Lawrenceville
country: United States
facility: Physicians Research Associates, LLC
state: Georgia
city: Macon
country: United States
facility: The Jones Center for Diabetes and Endrocrine Wellness
state: Georgia
city: Peachtree Corners
country: United States
facility: In-Quest Medical Research, LLC
state: Georgia
city: Roswell
country: United States
facility: Endocrine Research Solutions, Inc.
state: Georgia
city: Idaho Falls
country: United States
facility: Rocky Mountain Diabetes And Osteoporosis Center
state: Idaho
city: Meridian
country: United States
facility: Advanced Clinical Research
state: Idaho
city: Arlington Heights
country: United States
facility: Northwest Endo Diabets Res.LLC
state: Illinois
city: Crystal Lake
country: United States
facility: Midwest Endocrinology
state: Illinois
city: Skokie
country: United States
facility: NorthShore University Health System
state: Illinois
city: Jeffersonville
country: United States
facility: American Research, LLC
state: Indiana
city: Council Bluffs
country: United States
facility: West Broadway Clinic
state: Iowa
city: West Des Moines
country: United States
facility: Iowa Diabetes and Endocrinology Research Center (IDERC)
state: Iowa
city: Overland Park
country: United States
facility: Overland Park Surgical Specialties, LLC d/b/a College Park Family Care Center Physicians Group
state: Kansas
city: Topeka
country: United States
facility: Cotton O'Neil Clinical Research Ctr
state: Kansas
city: Lexington
country: United States
facility: Veterans Affairs Medical Center
state: Kentucky
city: Lexington
country: United States
facility: Kentucky Diabetes And Endocrinology Center
state: Kentucky
city: Metairie
country: United States
facility: Crescent City Clinical Research Center, LLC
state: Louisiana
city: Baltimore
country: United States
facility: Model Clinical Research
state: Maryland
city: Boston
country: United States
facility: Boston University School Of Medicine
state: Massachusetts
city: Waltham
country: United States
facility: MassResearch
state: Massachusetts
city: Flint
country: United States
facility: Elite Clinical Research
state: Michigan
city: Traverse City
country: United States
facility: Professional Clinical Research
state: Michigan
city: Chesterfield
country: United States
facility: Diabetes & Endocrinology Specialists, Inc.
state: Missouri
city: Jefferson City
country: United States
facility: Jefferson City Medical Group (Jcmg) - Jcmg Medical Building
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Springfield
country: United States
facility: Mercy Research
state: Missouri
city: Billings
country: United States
facility: Billings Clinic Research Center
state: Montana
city: Butte
country: United States
facility: Mercury Street Medical Group, PLLC
state: Montana
city: Kalispell
country: United States
facility: Glacier View Research Institute - Endocrinology
state: Montana
city: Omaha
country: United States
facility: Diabetes & Endocrine Associates, PC Research Center
state: Nebraska
city: Omaha
country: United States
facility: Alegent Health Research Center
state: Nebraska
city: Las Vegas
country: United States
facility: Palm Research Center, Inc.
state: Nevada
city: Reno
country: United States
facility: Northern Nevada Endocrinology
state: Nevada
city: Nashua
country: United States
facility: Southern New Hampshire Diabetes and Endocrinology
state: New Hampshire
city: Albany
country: United States
facility: Albany Medical College
state: New York
city: Brooklyn
country: United States
facility: NY Scientific
state: New York
city: Great Neck
country: United States
facility: Northwell Health
state: New York
city: Laurelton
country: United States
facility: Scott Research,Inc
state: New York
city: Mineola
country: United States
facility: Winthrop-University Hospital, Clinical Trials Center
state: New York
city: New Hyde Park
country: United States
facility: North Shore Diabetes and Endocrine Associates
state: New York
city: New York
country: United States
facility: Endocrine Associates of West Village
state: New York
city: New York
country: United States
facility: Manhattan Medical Research Practice
state: New York
city: Yonkers
country: United States
facility: Dr. Jonas Leibowitz MD, Office Of
state: New York
city: Asheville
country: United States
facility: Mountain Diabetes
state: North Carolina
city: Greensboro
country: United States
facility: Medication Management, LLC
state: North Carolina
city: Greenville
country: United States
facility: Physician's East, PA
state: North Carolina
city: Morehead City
country: United States
facility: Carteret Medical Group
state: North Carolina
city: Morehead City
country: United States
facility: Lucas Research, Inc.
state: North Carolina
city: Raleigh
country: United States
facility: Medication Management, LLC
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington, LLC
state: North Carolina
city: Fargo
country: United States
facility: Lillestol Research LLC
state: North Dakota
city: Canton
country: United States
facility: Diabetes & Endocrinology Associates of Stark County Inc
state: Ohio
city: Cincinnati
country: United States
facility: Sterling Research Group, Ltd
state: Ohio
city: Cleveland
country: United States
facility: Rapid Medical Research, Inc.
state: Ohio
city: Norman
country: United States
facility: Intend Clinical Research
state: Oklahoma
city: Norman
country: United States
facility: Lynn Institute of Norman
state: Oklahoma
city: Bend
country: United States
facility: Endocrinology Service Northwest LLC - Bend; Advanced Specialty Care (ASC) - Bend Office
state: Oregon
city: Warwick
country: United States
facility: Care Access Research, Warwick
state: Rhode Island
city: Greer
country: United States
facility: Mountain View Clinical Research, Inc.
state: South Carolina
city: Myrtle Beach
country: United States
facility: Carolina Health Specialist
state: South Carolina
city: Dakota Dunes
country: United States
facility: Meridian Clinical Research
state: South Dakota
city: Bristol
country: United States
facility: Holston Medical Group
state: Tennessee
city: Chattanooga
country: United States
facility: University Diabetes & Endocrine Consultants
state: Tennessee
city: Chattanooga
country: United States
facility: WR Clinsearch, LLC
state: Tennessee
city: Nashville
country: United States
facility: Omega Research Nashville, LLC
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Amarillo
country: United States
facility: Amarillo Medical Specialists
state: Texas
city: Austin
country: United States
facility: Texas Diabetes & Endocrinology
state: Texas
city: Dallas
country: United States
facility: North Texas Endocrine Center
state: Texas
city: Dallas
country: United States
facility: Research Institute of Dallas
state: Texas
city: Dallas
country: United States
facility: Baylor Research Institute
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center Division of Endocrinology
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: El Paso
country: United States
facility: Academy of Diabetes Thyroid and Endocrine
state: Texas
city: Fort Worth
country: United States
facility: Diabetes and Thyroid Center of Fort Worth
state: Texas
city: Houston
country: United States
facility: Victorium Clinical Research
state: Texas
city: Houston
country: United States
facility: Juno Research, LLC
state: Texas
city: Houston
country: United States
facility: Endocrine IPS, PLLC
state: Texas
city: Houston
country: United States
facility: Clinova Clinical Trials
state: Texas
city: Houston
country: United States
facility: Biopharma Informatic, LLC
state: Texas
city: Houston
country: United States
facility: Dr.Amir Ali Hassan, MD Off of
state: Texas
city: North Richland Hills
country: United States
facility: North Hills Medical Research, Inc.
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc
state: Texas
city: San Antonio
country: United States
facility: Science Advancing Medicine (Sam) Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Victorium Clinical Research
state: Texas
city: Schertz
country: United States
facility: Northeast Clinical Research, LLC
state: Texas
city: Shavano Park
country: United States
facility: Consano Clinical Research
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research
state: Texas
city: Webster
country: United States
facility: Bay Area Metabolic Health
state: Texas
city: Salt Lake City
country: United States
facility: Wasatch Clinical Research,LLC
state: Utah
city: Bennington
country: United States
facility: Dr.David Gorson Md, Office Of
state: Vermont
city: Manassas
country: United States
facility: Manassas Clinical Research Center
state: Virginia
city: Federal Way
country: United States
facility: Dr. Larry D. Stonesifer,MD,Office Of
state: Washington
city: Spokane
country: United States
facility: Multicare Health System Research Institute
state: Washington
city: Vancouver
country: United States
facility: The Vancouver Clinic, Inc. PS
state: Washington
Study officials:
References:
citation: 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.