Mylan Insulin Aspart Study
- Conditions
- Diabetes Mellitus, Type 1
- Interventions
- Drug: MYL-1601D ProductDrug: FlexPen NovoLog®
- Registration Number
- NCT03760068
- Lead Sponsor
- Mylan Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 478
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MYL-1601D Product (100 U/mL) MYL-1601D Product - FlexPen NovoLog® (100 U/mL) FlexPen NovoLog® -
- Primary Outcome Measures
Name Time Method Treatment Emergent Antibody Response (TEAR) Baseline to week 24 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.
- Secondary Outcome Measures
Name Time Method Change in Prandial Insulin Dose From Baseline Baseline to week 24 Mean (SD) change from baseline daily mealtime insulin dose at Week 24.
Change in HbA1c From Baseline Baseline to week 24 Mean (SD) change from baseline HbA1c at Week 24.
Change in Fasting Plasma Glucose From Baseline Baseline to week 24 Mean (SD) change from baseline plasma glucose at Week 24.
Change in Total Daily Insulin Dose From Baseline Baseline to week 24 Mean (SD) change from baseline total daily insulin dose at Week 24
Change in Basal Insulin Dose From Baseline Baseline to week 24 Mean (SD) change from baseline total daily insulin dose at Week 24.
Change in 7-point Self-monitored Blood Glucose (SMBG) Profile From Baseline Baseline to week 24 Mean (SD) change in 7-point SMBG profile from baseline to Week 24
Trial Locations
- Locations (151)
Atlanta Diabetes Associates
🇺🇸Atlanta, Georgia, United States
Hanson Clinical Research Center
🇺🇸Port Charlotte, Florida, United States
Diabetes Research Center
🇺🇸Tustin, California, United States
NorthShore University Health System
🇺🇸Skokie, Illinois, United States
Rapid Medical Research, Inc.
🇺🇸Cleveland, Ohio, 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
Juno Research, LLC
🇺🇸Houston, Texas, United States
Clinova Clinical Trials
🇺🇸Houston, Texas, United States
Biopharma Informatic, LLC
🇺🇸Houston, Texas, United States
Glacier View Research Institute - Endocrinology
🇺🇸Kalispell, Montana, United States
Albany Medical College
🇺🇸Albany, New York, United States
Clinical Trials of Texas, Inc
🇺🇸San Antonio, Texas, United States
Victorium Clinical Research
🇺🇸San Antonio, Texas, United States
Palm Research Center, Inc.
🇺🇸Las Vegas, Nevada, United States
Omega Research Nashville, LLC
🇺🇸Nashville, Tennessee, United States
Wasatch Clinical Research,LLC
🇺🇸Salt Lake City, Utah, United States
Phoenician Centers for Research
🇺🇸Phoenix, Arizona, United States
Endocrinology Associates Montgomery
🇺🇸Montgomery, Alabama, United States
Precision Trials
🇺🇸Phoenix, Arizona, United States
The Metabolic Institute Of America (Mioa Inc)
🇺🇸Tarzana, California, United States
Long Beach Center For Clinical Research
🇺🇸Long Beach, California, United States
Diabetes/Lipid Management and Research Center
🇺🇸Huntington Beach, California, United States
Diabetes And Endocrine Associates
🇺🇸La Mesa, California, United States
The Rose Salter Medical Research Foundation
🇺🇸Newport Beach, California, United States
Diablo Clinical Research, Inc.
🇺🇸Walnut Creek, California, United States
Model Clinical Research
🇺🇸Baltimore, Maryland, United States
MassResearch
🇺🇸Waltham, Massachusetts, United States
Mountain Diabetes
🇺🇸Asheville, North Carolina, United States
Lillestol Research LLC
🇺🇸Fargo, North Dakota, United States
Care Access Research, Warwick
🇺🇸Warwick, Rhode Island, United States
The Vancouver Clinic, Inc. PS
🇺🇸Vancouver, Washington, United States
DM Clinical Research
🇺🇸Tomball, Texas, United States
Intend Clinical Research
🇺🇸Norman, Oklahoma, United States
Mountain View Clinical Research, Inc.
🇺🇸Greer, South Carolina, United States
Endocrine IPS, PLLC
🇺🇸Houston, Texas, United States
Billings Clinic Research Center
🇺🇸Billings, Montana, United States
Endocrinology Service Northwest LLC - Bend; Advanced Specialty Care (ASC) - Bend Office
🇺🇸Bend, Oregon, United States
Science Advancing Medicine (Sam) Clinical Research
🇺🇸San Antonio, Texas, United States
Physician's East, PA
🇺🇸Greenville, North Carolina, United States
Dr. Larry D. Stonesifer,MD,Office Of
🇺🇸Federal Way, Washington, United States
Manhattan Medical Research Practice
🇺🇸New York, New York, United States
Dr. Jonas Leibowitz MD, Office Of
🇺🇸Yonkers, New York, United States
PMG Research of Wilmington, LLC
🇺🇸Wilmington, North Carolina, United States
Dr.Amir Ali Hassan, MD Off of
🇺🇸Houston, Texas, United States
Lucas Research, Inc.
🇺🇸Morehead City, North Carolina, United States
North Hills Medical Research, Inc.
🇺🇸North Richland Hills, Texas, United States
Bay Area Metabolic Health
🇺🇸Webster, Texas, United States
Texas Diabetes & Endocrinology
🇺🇸Austin, Texas, United States
Holston Medical Group
🇺🇸Bristol, Tennessee, United States
University Diabetes & Endocrine Consultants
🇺🇸Chattanooga, Tennessee, United States
Consano Clinical Research
🇺🇸Shavano Park, Texas, United States
UT Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Multicare Health System Research Institute
🇺🇸Spokane, Washington, United States
Dr.David Gorson Md, Office Of
🇺🇸Bennington, Vermont, United States
WR Clinsearch, LLC
🇺🇸Chattanooga, Tennessee, United States
John Muir Physician Network
🇺🇸Concord, California, United States
Valley Research
🇺🇸Fresno, California, United States
Medical Investigations Inc.
🇺🇸Little Rock, Arkansas, United States
Marin Endocrine Care & Research, Inc.
🇺🇸Greenbrae, California, United States
Office of Richard S. Cherlin, M.D
🇺🇸Los Gatos, California, United States
Providence Clinical Research
🇺🇸North Hollywood, California, United States
Pacific Reserach Partners
🇺🇸Oakland, California, United States
California Medical Research Associates Inc
🇺🇸Northridge, California, United States
Coastal Biomedical Research, Inc.
🇺🇸Santa Monica, California, United States
Sansum Diabetes Research Institute
🇺🇸Santa Barbara, 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
Dr.Ronald H. Chochinov MD,Office Of
🇺🇸Ventura, California, United States
New West Physicians
🇺🇸Golden, Colorado, United States
Paradigm Research
🇺🇸Wheat Ridge, Colorado, 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
East Coast Institute for Research, LLC
🇺🇸Jacksonville, Florida, United States
Inpatient Research Clinic
🇺🇸Miami Lakes, Florida, United States
Central Florida Endocrine & Diabetes Consultants
🇺🇸Maitland, Florida, United States
Care Research Center, Inc
🇺🇸Kendall, Florida, United States
Eastern Research, Inc.
🇺🇸Hialeah, Florida, United States
Ribo Research, LLC dba Peninsula Research, Inc
🇺🇸Ormond Beach, Florida, United States
Suncoast Clinical Research Inc.
🇺🇸Palm Harbor, Florida, United States
Progressive Medical Research
🇺🇸Port Orange, Florida, United States
Asclepes Research Centers
🇺🇸Weeki Wachee, Florida, United States
IACT Health
🇺🇸Columbus, Georgia, United States
Physicians Research Associates, LLC
🇺🇸Lawrenceville, Georgia, United States
In-Quest Medical Research, LLC
🇺🇸Peachtree Corners, Georgia, United States
Metabolic Research Institute, Inc.
🇺🇸West Palm Beach, Florida, United States
Advanced Clinical Research
🇺🇸Meridian, Idaho, United States
The Jones Center for Diabetes and Endrocrine Wellness
🇺🇸Macon, Georgia, United States
Endocrine Research Solutions, Inc.
🇺🇸Roswell, Georgia, United States
Rocky Mountain Diabetes And Osteoporosis Center
🇺🇸Idaho Falls, Idaho, United States
American Research, LLC
🇺🇸Jeffersonville, Indiana, United States
Northwest Endo Diabets Res.LLC
🇺🇸Arlington Heights, Illinois, United States
Midwest Endocrinology
🇺🇸Crystal Lake, Illinois, 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
West Broadway Clinic
🇺🇸Council Bluffs, Iowa, United States
Cotton O'Neil Clinical Research Ctr
🇺🇸Topeka, Kansas, United States
Veterans Affairs Medical Center
🇺🇸Lexington, Kentucky, United States
Crescent City Clinical Research Center, LLC
🇺🇸Metairie, Louisiana, United States
Kentucky Diabetes And Endocrinology Center
🇺🇸Lexington, Kentucky, United States
Boston University School Of Medicine
🇺🇸Boston, Massachusetts, United States
Professional Clinical Research
🇺🇸Traverse City, Michigan, United States
Diabetes & Endocrinology Specialists, Inc.
🇺🇸Chesterfield, Missouri, United States
Elite Clinical Research
🇺🇸Flint, Michigan, United States
Mercy Research
🇺🇸Springfield, Missouri, United States
Jefferson City Medical Group (Jcmg) - Jcmg Medical Building
🇺🇸Jefferson City, Missouri, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Mercury Street Medical Group, PLLC
🇺🇸Butte, Montana, United States
Southern New Hampshire Diabetes and Endocrinology
🇺🇸Nashua, New Hampshire, United States
Northern Nevada Endocrinology
🇺🇸Reno, Nevada, 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
North Shore Diabetes and Endocrine Associates
🇺🇸New Hyde Park, New York, United States
Winthrop-University Hospital, Clinical Trials Center
🇺🇸Mineola, New York, United States
Endocrine Associates of West Village
🇺🇸New York, New York, United States
Carteret Medical Group
🇺🇸Morehead City, North Carolina, United States
Medication Management, LLC
🇺🇸Raleigh, North Carolina, United States
Diabetes & Endocrinology Associates of Stark County Inc
🇺🇸Canton, Ohio, United States
Sterling Research Group, Ltd
🇺🇸Cincinnati, Ohio, United States
Lynn Institute of Norman
🇺🇸Norman, Oklahoma, United States
Carolina Health Specialist
🇺🇸Myrtle Beach, South Carolina, United States
Meridian Clinical Research
🇺🇸Dakota Dunes, South Dakota, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Research Institute of Dallas
🇺🇸Dallas, Texas, United States
Amarillo Medical Specialists
🇺🇸Amarillo, Texas, United States
North Texas Endocrine Center
🇺🇸Dallas, Texas, United States
UT Southwestern Medical Center Division of Endocrinology
🇺🇸Dallas, Texas, United States
Academy of Diabetes Thyroid and Endocrine
🇺🇸El Paso, Texas, United States
Baylor Research Institute
🇺🇸Dallas, Texas, United States
Diabetes and Thyroid Center of Fort Worth
🇺🇸Fort Worth, Texas, United States
Northeast Clinical Research, LLC
🇺🇸Schertz, Texas, United States
Manassas Clinical Research Center
🇺🇸Manassas, Virginia, United States
Creekside Endocrine Associates, PC
🇺🇸Denver, Colorado, United States
Barbara Davis Center for Diabetes
🇺🇸Aurora, Colorado, United States
Clinical Neurosciecne Solutions, Inc. dba CNS Healthcare
🇺🇸Orlando, Florida, United States
Omega Research Maitland, LLC
🇺🇸Orlando, Florida, United States
Meridien Research
🇺🇸Tampa, Florida, United States
Diabetes & Endocrine Associates, PC Research Center
🇺🇸Omaha, Nebraska, United States
Alegent Health Research Center
🇺🇸Omaha, Nebraska, United States
Palmtree Clinical Research, Inc.
🇺🇸Palm Springs, California, United States