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Completed Phase 3 Interventional Results available

Mylan Insulin Aspart Study

ClinicalTrials.gov ID: NCT03760068

Public ClinicalTrials.gov record NCT03760068. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 29, 2026, 9:35 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT03760068
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Mylan Inc.
Industry
Enrollment
478 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 65 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 7, 2018 (Actual)
Primary completion
Dec 28, 2019 (Actual)
Completion
Jan 17, 2020 (Actual)
Last update posted
Feb 25, 2022

2018 – 2020

United States locations

U.S. sites
158
U.S. states
37
U.S. cities
128
Facility City State ZIP Site status
Endocrinology Associates Montgomery Montgomery Alabama 36106 —
Phoenician Centers for Research Phoenix Arizona 85012 —
Precision Trials Phoenix Arizona 85032 —
Medical Investigations Inc. Little Rock Arkansas 72211 —
John Muir Physician Network Concord California 94520 —
Valley Research Fresno California 93720 —
Marin Endocrine Care & Research, Inc. Greenbrae California 94904 —
Diabetes/Lipid Management and Research Center Huntington Beach California 92648 —
Diabetes And Endocrine Associates La Mesa California 91942 —
Long Beach Center For Clinical Research Long Beach California 90807 —
Office of Richard S. Cherlin, M.D Los Gatos California 95032 —
The Rose Salter Medical Research Foundation Newport Beach California 92657 —
Providence Clinical Research North Hollywood California 91606 —
California Medical Research Associates Inc Northridge California 91324 —
Pacific Reserach Partners Oakland California 94607 —
Palmtree Clinical Research, Inc. Palm Springs California 92262 —
Western Univ of Health Science Pomona California 91766 —
Mills-Peninsula Health Services Diabetes Research Institute San Mateo California 94401 —
NorCal Endocrinology and Internal Medicine San Ramon California 94583 —
Sansum Diabetes Research Institute Santa Barbara California 93105 —
Coastal Biomedical Research, Inc. Santa Monica California 90404 —
The Metabolic Institute Of America (Mioa Inc) Tarzana California 91356 —
Diabetes Research Center Tustin California 92780 —
Dr.Ronald H. Chochinov MD,Office Of Ventura California 93003 —
Diablo Clinical Research, Inc. Walnut Creek California 94598 —
Barbara Davis Center for Diabetes Aurora Colorado 80045 —
Creekside Endocrine Associates, PC Denver Colorado 80246 —
New West Physicians Golden Colorado 80401 —
Paradigm Research Wheat Ridge Colorado 80033 —
Meridien Research Bradenton Florida 34201 —
Hi Tech and Global Research, LLC Coral Gables Florida 33134 —
Moonshine Research Center, Inc. Doral Florida 33166 —
Northeast Research Institute Fleming Island Florida 32003 —
Eastern Research, Inc. Hialeah Florida 33013 —
East Coast Institute for Research, LLC Jacksonville Florida 32216 —
Care Research Center, Inc Kendall Florida 33175 —
Meridien Research Lakeland Florida 33805 —
Central Florida Endocrine & Diabetes Consultants Maitland Florida 32751 —
Meridien Research Maitland Florida 32751 —
Pharmax Research Clinic, Inc. Miami Florida 33126 —
Quality Professional Healthcare Miami Florida 33126 —
Life Spring Research Foundation Miami Florida 33130 —
Cordova Research Institute Miami Florida 33155 —
DL Research Solutions Inc Miami Florida 33155 —
Baptist Diabetes Associates, Pa Miami Florida 33156 —
Medi Clear Medical & Research Center, Inc Miami Florida 33165 —
Phoenix Medical Research LLC Miami Florida 33165 —
Dr. De Armas Research Center, LLC Miami Florida 33174 —
P & S Research, LLC Miami Florida 33175 —
Inpatient Research Clinic Miami Lakes Florida 33014 —
Clinical Neurosciecne Solutions, Inc. dba CNS Healthcare Orlando Florida 32806 —
Omega Research Maitland, LLC Orlando Florida 32808 —
Ribo Research, LLC dba Peninsula Research, Inc Ormond Beach Florida 32174 —
Suncoast Clinical Research Inc. Palm Harbor Florida 34684 —
Hanson Clinical Research Center Port Charlotte Florida 33952 —
Progressive Medical Research Port Orange Florida 32127 —
Meridien Research Spring Hill Florida 34609 —
Meridien Research St. Petersburg Florida 33709 —
Meridien Research Tampa Florida 33634 —
Asclepes Research Centers Weeki Wachee Florida 34607 —
Metabolic Research Institute, Inc. West Palm Beach Florida 33401 —
Atlanta Diabetes Associates Atlanta Georgia 30318 —
IACT Health Columbus Georgia 31904 —
Physicians Research Associates, LLC Lawrenceville Georgia 30046 —
The Jones Center for Diabetes and Endrocrine Wellness Macon Georgia 31210 —
In-Quest Medical Research, LLC Peachtree Corners Georgia 30071 —
Endocrine Research Solutions, Inc. Roswell Georgia 30076 —
Rocky Mountain Diabetes And Osteoporosis Center Idaho Falls Idaho 83404 —
Advanced Clinical Research Meridian Idaho 83642 —
Northwest Endo Diabets Res.LLC Arlington Heights Illinois 60005 —
Midwest Endocrinology Crystal Lake Illinois 60012 —
NorthShore University Health System Skokie Illinois 60077 —
American Research, LLC Jeffersonville Indiana 47130 —
West Broadway Clinic Council Bluffs Iowa 51501 —
Iowa Diabetes and Endocrinology Research Center (IDERC) West Des Moines Iowa 50265 —
Overland Park Surgical Specialties, LLC d/b/a College Park Family Care Center Physicians Group Overland Park Kansas 66210 —
Cotton O'Neil Clinical Research Ctr Topeka Kansas 66606 —
Veterans Affairs Medical Center Lexington Kentucky 40502 —
Kentucky Diabetes And Endocrinology Center Lexington Kentucky 40503 —
Crescent City Clinical Research Center, LLC Metairie Louisiana 70006 —
Model Clinical Research Baltimore Maryland 21204 —
Boston University School Of Medicine Boston Massachusetts 02118 —
MassResearch Waltham Massachusetts 02453 —
Elite Clinical Research Flint Michigan 48532 —
Professional Clinical Research Traverse City Michigan 49686 —
Diabetes & Endocrinology Specialists, Inc. Chesterfield Missouri 63017 —
Jefferson City Medical Group (Jcmg) - Jcmg Medical Building Jefferson City Missouri 65109 —
Mercy Research Springfield Missouri 65807 —
Washington University School of Medicine St Louis Missouri 63110 —
Billings Clinic Research Center Billings Montana 59101 —
Mercury Street Medical Group, PLLC Butte Montana 59701 —
Glacier View Research Institute - Endocrinology Kalispell Montana 59901 —
Diabetes & Endocrine Associates, PC Research Center Omaha Nebraska 68114 —
Alegent Health Research Center Omaha Nebraska 68124 —
Palm Research Center, Inc. Las Vegas Nevada 89148 —
Northern Nevada Endocrinology Reno Nevada 89519 —
Southern New Hampshire Diabetes and Endocrinology Nashua New Hampshire 03063 —
Albany Medical College Albany New York 12206 —
NY Scientific Brooklyn New York 11235 —
Northwell Health Great Neck New York 11021 —
Scott Research,Inc Laurelton New York 11413 —
Winthrop-University Hospital, Clinical Trials Center Mineola New York 11501 —
North Shore Diabetes and Endocrine Associates New Hyde Park New York 11042 —
Endocrine Associates of West Village New York New York 10001 —
Manhattan Medical Research Practice New York New York 10016 —
Dr. Jonas Leibowitz MD, Office Of Yonkers New York 10704 —
Mountain Diabetes Asheville North Carolina 28803 —
Medication Management, LLC Greensboro North Carolina 27408 —
Physician's East, PA Greenville North Carolina 27834 —
Carteret Medical Group Morehead City North Carolina 28557 —
Lucas Research, Inc. Morehead City North Carolina 28857 —
Medication Management, LLC Raleigh North Carolina 27609 —
PMG Research of Wilmington, LLC Wilmington North Carolina 28401 —
Lillestol Research LLC Fargo North Dakota 58104 —
Diabetes & Endocrinology Associates of Stark County Inc Canton Ohio 44718 —
Sterling Research Group, Ltd Cincinnati Ohio 45246 —
Rapid Medical Research, Inc. Cleveland Ohio 44122 —
Intend Clinical Research Norman Oklahoma 73069 —
Lynn Institute of Norman Norman Oklahoma 73069 —
Endocrinology Service Northwest LLC - Bend; Advanced Specialty Care (ASC) - Bend Office Bend Oregon 97702 —
Care Access Research, Warwick Warwick Rhode Island 02886 —
Mountain View Clinical Research, Inc. Greer South Carolina 29651 —
Carolina Health Specialist Myrtle Beach South Carolina 29572 —
Meridian Clinical Research Dakota Dunes South Dakota 57049 —
Holston Medical Group Bristol Tennessee 37620 —
University Diabetes & Endocrine Consultants Chattanooga Tennessee 37411 —
WR Clinsearch, LLC Chattanooga Tennessee 37421 —
Omega Research Nashville, LLC Nashville Tennessee 37211 —
Vanderbilt University Medical Center Nashville Tennessee 37212 —
Amarillo Medical Specialists Amarillo Texas 79106 —
Texas Diabetes & Endocrinology Austin Texas 78731 —
North Texas Endocrine Center Dallas Texas 75231 —
Research Institute of Dallas Dallas Texas 75231 —
Baylor Research Institute Dallas Texas 75246 —
UT Southwestern Medical Center Division of Endocrinology Dallas Texas 75390 —
UT Southwestern Medical Center Dallas Texas 75390 —
Academy of Diabetes Thyroid and Endocrine El Paso Texas 79935 —
Diabetes and Thyroid Center of Fort Worth Fort Worth Texas 76132 —
Victorium Clinical Research Houston Texas 77024 —
Juno Research, LLC Houston Texas 77040 —
Endocrine IPS, PLLC Houston Texas 77079 —
Clinova Clinical Trials Houston Texas 77082 —
Biopharma Informatic, LLC Houston Texas 77084 —
Dr.Amir Ali Hassan, MD Off of Houston Texas 77089 —
North Hills Medical Research, Inc. North Richland Hills Texas 76180 —
Clinical Trials of Texas, Inc San Antonio Texas 78229 —
Science Advancing Medicine (Sam) Clinical Research San Antonio Texas 78229 —
Victorium Clinical Research San Antonio Texas 78230 —
Northeast Clinical Research, LLC Schertz Texas 78154 —
Consano Clinical Research Shavano Park Texas 78231 —
DM Clinical Research Tomball Texas 77375 —
Bay Area Metabolic Health Webster Texas 77598 —
Wasatch Clinical Research,LLC Salt Lake City Utah 84107 —
Dr.David Gorson Md, Office Of Bennington Vermont 05201 —
Manassas Clinical Research Center Manassas Virginia 20110 —
Dr. Larry D. Stonesifer,MD,Office Of Federal Way Washington 98003 —
Multicare Health System Research Institute Spokane Washington 99202 —
The Vancouver Clinic, Inc. PS Vancouver Washington 98664 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03760068, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 25, 2022 · Synced Oct 29, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03760068 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →