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Diabetes Mellitus, Type 1Phase 3NCT03760068

Mylan Insulin Aspart Study

A Phase 3 study testing MYL-1601D Product and FlexPen NovoLog® in people with Diabetes Mellitus, Type 1, run by Mylan Inc. at 158 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Diabetes Mellitus, Type 1
What is being tested?
MYL-1601D Product and FlexPen NovoLog®
Could I receive a placebo?
No, everyone receives an active treatment
How many people
478 participants
Where
158 sitesUnited States
Study dates
7 Nov 2018to 17 Jan 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

158 sites in 1 country.

158 sites in 1 country

United States158 sites

  • Albany Medical College

    Albany, New York, 12206

  • Amarillo Medical Specialists

    Amarillo, Texas, 79106

  • Northwest Endo Diabets Res.LLC

    Arlington Heights, Illinois, 60005

  • Mountain Diabetes

    Asheville, North Carolina, 28803

  • Atlanta Diabetes Associates

    Atlanta, Georgia, 30318

  • Barbara Davis Center for Diabetes

    Aurora, Colorado, 80045

  • Texas Diabetes & Endocrinology

    Austin, Texas, 78731

  • Model Clinical Research

    Baltimore, Maryland, 21204

  • Endocrinology Service Northwest LLC - Bend; Advanced Specialty Care (ASC) - Bend Office

    Bend, Oregon, 97702

  • Dr.David Gorson Md, Office Of

    Bennington, Vermont, 05201

  • Billings Clinic Research Center

    Billings, Montana, 59101

  • Boston University School Of Medicine

    Boston, Massachusetts, 02118

  • Meridien Research

    Bradenton, Florida, 34201

  • Holston Medical Group

    Bristol, Tennessee, 37620

  • NY Scientific

    Brooklyn, New York, 11235

  • Mercury Street Medical Group, PLLC

    Butte, Montana, 59701

  • Diabetes & Endocrinology Associates of Stark County Inc

    Canton, Ohio, 44718

  • University Diabetes & Endocrine Consultants

    Chattanooga, Tennessee, 37411

  • WR Clinsearch, LLC

    Chattanooga, Tennessee, 37421

  • Diabetes & Endocrinology Specialists, Inc.

    Chesterfield, Missouri, 63017

  • Sterling Research Group, Ltd

    Cincinnati, Ohio, 45246

  • Rapid Medical Research, Inc.

    Cleveland, Ohio, 44122

  • IACT Health

    Columbus, Georgia, 31904

  • John Muir Physician Network

    Concord, California, 94520

  • Hi Tech and Global Research, LLC

    Coral Gables, Florida, 33134

  • West Broadway Clinic

    Council Bluffs, Iowa, 51501

  • Midwest Endocrinology

    Crystal Lake, Illinois, 60012

  • Meridian Clinical Research

    Dakota Dunes, South Dakota, 57049

  • 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

  • Creekside Endocrine Associates, PC

    Denver, Colorado, 80246

  • Moonshine Research Center, Inc.

    Doral, Florida, 33166

  • Academy of Diabetes Thyroid and Endocrine

    El Paso, Texas, 79935

  • Lillestol Research LLC

    Fargo, North Dakota, 58104

  • Dr. Larry D. Stonesifer,MD,Office Of

    Federal Way, Washington, 98003

  • Northeast Research Institute

    Fleming Island, Florida, 32003

  • Elite Clinical Research

    Flint, Michigan, 48532

  • Diabetes and Thyroid Center of Fort Worth

    Fort Worth, Texas, 76132

  • Valley Research

    Fresno, California, 93720

  • New West Physicians

    Golden, Colorado, 80401

  • Northwell Health

    Great Neck, New York, 11021

  • Marin Endocrine Care & Research, Inc.

    Greenbrae, California, 94904

  • Medication Management, LLC

    Greensboro, North Carolina, 27408

  • Physician's East, PA

    Greenville, North Carolina, 27834

  • Mountain View Clinical Research, Inc.

    Greer, South Carolina, 29651

  • Eastern Research, Inc.

    Hialeah, Florida, 33013

  • 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

  • Diabetes/Lipid Management and Research Center

    Huntington Beach, California, 92648

  • Rocky Mountain Diabetes And Osteoporosis Center

    Idaho Falls, Idaho, 83404

  • East Coast Institute for Research, LLC

    Jacksonville, Florida, 32216

  • Jefferson City Medical Group (Jcmg) - Jcmg Medical Building

    Jefferson City, Missouri, 65109

  • American Research, LLC

    Jeffersonville, Indiana, 47130

  • Glacier View Research Institute - Endocrinology

    Kalispell, Montana, 59901

  • Care Research Center, Inc

    Kendall, Florida, 33175

  • Diabetes And Endocrine Associates

    La Mesa, California, 91942

  • Meridien Research

    Lakeland, Florida, 33805

  • Palm Research Center, Inc.

    Las Vegas, Nevada, 89148

  • Scott Research,Inc

    Laurelton, New York, 11413

  • Physicians Research Associates, LLC

    Lawrenceville, Georgia, 30046

  • Veterans Affairs Medical Center

    Lexington, Kentucky, 40502

  • Kentucky Diabetes And Endocrinology Center

    Lexington, Kentucky, 40503

  • Medical Investigations Inc.

    Little Rock, Arkansas, 72211

  • Long Beach Center For Clinical Research

    Long Beach, California, 90807

  • Office of Richard S. Cherlin, M.D

    Los Gatos, California, 95032

  • The Jones Center for Diabetes and Endrocrine Wellness

    Macon, Georgia, 31210

  • Central Florida Endocrine & Diabetes Consultants

    Maitland, Florida, 32751

  • Meridien Research

    Maitland, Florida, 32751

  • Manassas Clinical Research Center

    Manassas, Virginia, 20110

  • Advanced Clinical Research

    Meridian, Idaho, 83642

  • Crescent City Clinical Research Center, LLC

    Metairie, Louisiana, 70006

  • 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

  • Winthrop-University Hospital, Clinical Trials Center

    Mineola, New York, 11501

  • Endocrinology Associates Montgomery

    Montgomery, Alabama, 36106

  • Carteret Medical Group

    Morehead City, North Carolina, 28557

  • Lucas Research, Inc.

    Morehead City, North Carolina, 28857

  • Carolina Health Specialist

    Myrtle Beach, South Carolina, 29572

  • Southern New Hampshire Diabetes and Endocrinology

    Nashua, New Hampshire, 03063

  • Omega Research Nashville, LLC

    Nashville, Tennessee, 37211

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37212

  • 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

  • The Rose Salter Medical Research Foundation

    Newport Beach, California, 92657

  • Intend Clinical Research

    Norman, Oklahoma, 73069

  • Lynn Institute of Norman

    Norman, Oklahoma, 73069

  • Providence Clinical Research

    North Hollywood, California, 91606

  • North Hills Medical Research, Inc.

    North Richland Hills, Texas, 76180

  • California Medical Research Associates Inc

    Northridge, California, 91324

  • Pacific Reserach Partners

    Oakland, California, 94607

  • Diabetes & Endocrine Associates, PC Research Center

    Omaha, Nebraska, 68114

  • Alegent Health Research Center

    Omaha, Nebraska, 68124

  • 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

  • Overland Park Surgical Specialties, LLC d/b/a College Park Family Care Center Physicians Group

    Overland Park, Kansas, 66210

  • Suncoast Clinical Research Inc.

    Palm Harbor, Florida, 34684

  • Palmtree Clinical Research, Inc.

    Palm Springs, California, 92262

  • In-Quest Medical Research, LLC

    Peachtree Corners, Georgia, 30071

  • Phoenician Centers for Research

    Phoenix, Arizona, 85012

  • Precision Trials

    Phoenix, Arizona, 85032

  • Western Univ of Health Science

    Pomona, California, 91766

  • Hanson Clinical Research Center

    Port Charlotte, Florida, 33952

  • Progressive Medical Research

    Port Orange, Florida, 32127

  • Medication Management, LLC

    Raleigh, North Carolina, 27609

  • Northern Nevada Endocrinology

    Reno, Nevada, 89519

  • Endocrine Research Solutions, Inc.

    Roswell, Georgia, 30076

  • Wasatch Clinical Research,LLC

    Salt Lake City, Utah, 84107

  • 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

  • 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

  • Northeast Clinical Research, LLC

    Schertz, Texas, 78154

  • Consano Clinical Research

    Shavano Park, Texas, 78231

  • NorthShore University Health System

    Skokie, Illinois, 60077

  • Multicare Health System Research Institute

    Spokane, Washington, 99202

  • Meridien Research

    Spring Hill, Florida, 34609

  • Mercy Research

    Springfield, Missouri, 65807

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Meridien Research

    St. Petersburg, Florida, 33709

  • Meridien Research

    Tampa, Florida, 33634

  • The Metabolic Institute Of America (Mioa Inc)

    Tarzana, California, 91356

  • DM Clinical Research

    Tomball, Texas, 77375

  • Cotton O'Neil Clinical Research Ctr

    Topeka, Kansas, 66606

  • Professional Clinical Research

    Traverse City, Michigan, 49686

  • Diabetes Research Center

    Tustin, California, 92780

  • The Vancouver Clinic, Inc. PS

    Vancouver, Washington, 98664

  • Dr.Ronald H. Chochinov MD,Office Of

    Ventura, California, 93003

  • Diablo Clinical Research, Inc.

    Walnut Creek, California, 94598

  • MassResearch

    Waltham, Massachusetts, 02453

  • Care Access Research, Warwick

    Warwick, Rhode Island, 02886

  • Bay Area Metabolic Health

    Webster, Texas, 77598

  • Asclepes Research Centers

    Weeki Wachee, Florida, 34607

  • Iowa Diabetes and Endocrinology Research Center (IDERC)

    West Des Moines, Iowa, 50265

  • Metabolic Research Institute, Inc.

    West Palm Beach, Florida, 33401

  • Paradigm Research

    Wheat Ridge, Colorado, 80033

  • PMG Research of Wilmington, LLC

    Wilmington, North Carolina, 28401

  • Dr. Jonas Leibowitz MD, Office Of

    Yonkers, New York, 10704

Other trials in United States

About this 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

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.

Read the 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.

Being tested
MYL-1601D Product, FlexPen NovoLog®
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MYL-1601D ProductDrug

    (100 U/mL)

  • FlexPen NovoLog®Drug

    (100 U/mL)

Study groups in NCT03760068
Study groupRoleWhat they receive
MYL-1601D Product (100 U/mL)Active comparatorNot described
Receives: Drug: MYL-1601D Product
FlexPen NovoLog® (100 U/mL)Active comparatorNot described
Receives: Drug: FlexPen NovoLog®

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline to week 24

Secondary outcomes (6)

  1. Change in HbA1c From Baseline

    Mean (SD) change from baseline HbA1c at Week 24.

    Measured: Baseline to week 24

  2. Change in Fasting Plasma Glucose From Baseline

    Mean (SD) change from baseline plasma glucose at Week 24.

    Measured: Baseline to week 24

  3. Change in Prandial Insulin Dose From Baseline

    Mean (SD) change from baseline daily mealtime insulin dose at Week 24.

    Measured: Baseline to week 24

  4. Change in Basal Insulin Dose From Baseline

    Mean (SD) change from baseline total daily insulin dose at Week 24.

    Measured: Baseline to week 24

  5. Change in Total Daily Insulin Dose From Baseline

    Mean (SD) change from baseline total daily insulin dose at Week 24

    Measured: Baseline to week 24

  6. Change in 7-point Self-monitored Blood Glucose (SMBG) Profile From Baseline

    Mean (SD) change in 7-point SMBG profile from baseline to Week 24

    Measured: Baseline to week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Nov 2018
  2. Study start7 Nov 2018
  3. Primary completion28 Dec 2019
  4. Study completion17 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
478 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03760068
Sponsor's protocol ID
MYL-1601D-3001
Status last verified
Feb 2022
First submitted
21 Nov 2018
Last updated
25 Feb 2022
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36114990

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MYL-1601D Product and FlexPen NovoLog® in people with Diabetes Mellitus, Type 1, run by Mylan Inc. at 158 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 158 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment Emergent Antibody Response (TEAR) (time frame: Baseline to week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03760068, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2022.

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