Mylan Insulin Aspart Study

February 23, 2022 updated by: Mylan Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

478

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: MYL-1601D Product (100 U/mL)
Drug: MYL-1601D Product
(100 U/mL)
Active Comparator: FlexPen NovoLog® (100 U/mL)
Drug: FlexPen NovoLog®
(100 U/mL)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment Emergent Antibody Response (TEAR)
Time Frame: 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.
Baseline to week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1c From Baseline
Time Frame: Baseline to week 24
Mean (SD) change from baseline HbA1c at Week 24.
Baseline to week 24
Change in Fasting Plasma Glucose From Baseline
Time Frame: Baseline to week 24
Mean (SD) change from baseline plasma glucose at Week 24.
Baseline to week 24
Change in Prandial Insulin Dose From Baseline
Time Frame: Baseline to week 24
Mean (SD) change from baseline daily mealtime insulin dose at Week 24.
Baseline to week 24
Change in Basal Insulin Dose From Baseline
Time Frame: Baseline to week 24
Mean (SD) change from baseline total daily insulin dose at Week 24.
Baseline to week 24
Change in Total Daily Insulin Dose From Baseline
Time Frame: Baseline to week 24
Mean (SD) change from baseline total daily insulin dose at Week 24
Baseline to week 24
Change in 7-point Self-monitored Blood Glucose (SMBG) Profile From Baseline
Time Frame: Baseline to week 24
Mean (SD) change in 7-point SMBG profile from baseline to Week 24
Baseline to week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mylan Inc.

Collaborators

Mylan GmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 7, 2018

Primary Completion (Actual)

December 28, 2019

Study Completion (Actual)

January 17, 2020

Study Registration Dates

First Submitted

November 21, 2018

First Submitted That Met QC Criteria

November 28, 2018

First Posted (Actual)

November 30, 2018

Study Record Updates

Last Update Posted (Actual)

February 25, 2022

Last Update Submitted That Met QC Criteria

February 23, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MYL-1601D-3001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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