search
Back to results

Mylan Insulin Aspart Study

Primary Purpose

Diabetes Mellitus, Type 1

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
MYL-1601D Product
FlexPen NovoLog®
Sponsored by
Mylan Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Endocrinology Associates Montgomery
  • Phoenician Centers for Research
  • Precision Trials
  • Medical Investigations Inc.
  • John Muir Physician Network
  • Valley Research
  • Marin Endocrine Care & Research, Inc.
  • Diabetes/Lipid Management and Research Center
  • Diabetes And Endocrine Associates
  • Long Beach Center For Clinical Research
  • Office of Richard S. Cherlin, M.D
  • The Rose Salter Medical Research Foundation
  • Providence Clinical Research
  • California Medical Research Associates Inc
  • Pacific Reserach Partners
  • Palmtree Clinical Research, Inc.
  • Western Univ of Health Science
  • Mills-Peninsula Health Services Diabetes Research Institute
  • NorCal Endocrinology and Internal Medicine
  • Sansum Diabetes Research Institute
  • Coastal Biomedical Research, Inc.
  • The Metabolic Institute Of America (Mioa Inc)
  • Diabetes Research Center
  • Dr.Ronald H. Chochinov MD,Office Of
  • Diablo Clinical Research, Inc.
  • Barbara Davis Center for Diabetes
  • Creekside Endocrine Associates, PC
  • New West Physicians
  • Paradigm Research
  • Meridien Research
  • Hi Tech and Global Research, LLC
  • Moonshine Research Center, Inc.
  • Northeast Research Institute
  • Eastern Research, Inc.
  • East Coast Institute for Research, LLC
  • Care Research Center, Inc
  • Meridien Research
  • Central Florida Endocrine & Diabetes Consultants
  • Meridien Research
  • Inpatient Research Clinic
  • Pharmax Research Clinic, Inc.
  • Quality Professional Healthcare
  • Life Spring Research Foundation
  • Cordova Research Institute
  • DL Research Solutions Inc
  • Baptist Diabetes Associates, Pa
  • Medi Clear Medical & Research Center, Inc
  • Phoenix Medical Research LLC
  • Dr. De Armas Research Center, LLC
  • P & S Research, LLC
  • Clinical Neurosciecne Solutions, Inc. dba CNS Healthcare
  • Omega Research Maitland, LLC
  • Ribo Research, LLC dba Peninsula Research, Inc
  • Suncoast Clinical Research Inc.
  • Hanson Clinical Research Center
  • Progressive Medical Research
  • Meridien Research
  • Meridien Research
  • Meridien Research
  • Asclepes Research Centers
  • Metabolic Research Institute, Inc.
  • Atlanta Diabetes Associates
  • IACT Health
  • Physicians Research Associates, LLC
  • The Jones Center for Diabetes and Endrocrine Wellness
  • In-Quest Medical Research, LLC
  • Endocrine Research Solutions, Inc.
  • Rocky Mountain Diabetes And Osteoporosis Center
  • Advanced Clinical Research
  • Northwest Endo Diabets Res.LLC
  • Midwest Endocrinology
  • NorthShore University Health System
  • American Research, LLC
  • West Broadway Clinic
  • Iowa Diabetes and Endocrinology Research Center (IDERC)
  • Overland Park Surgical Specialties, LLC d/b/a College Park Family Care Center Physicians Group
  • Cotton O'Neil Clinical Research Ctr
  • Veterans Affairs Medical Center
  • Kentucky Diabetes And Endocrinology Center
  • Crescent City Clinical Research Center, LLC
  • Model Clinical Research
  • Boston University School Of Medicine
  • MassResearch
  • Elite Clinical Research
  • Professional Clinical Research
  • Diabetes & Endocrinology Specialists, Inc.
  • Jefferson City Medical Group (Jcmg) - Jcmg Medical Building
  • Washington University School of Medicine
  • Mercy Research
  • Billings Clinic Research Center
  • Mercury Street Medical Group, PLLC
  • Glacier View Research Institute - Endocrinology
  • Diabetes & Endocrine Associates, PC Research Center
  • Alegent Health Research Center
  • Palm Research Center, Inc.
  • Northern Nevada Endocrinology
  • Southern New Hampshire Diabetes and Endocrinology
  • Albany Medical College
  • NY Scientific
  • Northwell Health
  • Scott Research,Inc
  • Winthrop-University Hospital, Clinical Trials Center
  • North Shore Diabetes and Endocrine Associates
  • Endocrine Associates of West Village
  • Manhattan Medical Research Practice
  • Dr. Jonas Leibowitz MD, Office Of
  • Mountain Diabetes
  • Medication Management, LLC
  • Physician's East, PA
  • Carteret Medical Group
  • Lucas Research, Inc.
  • Medication Management, LLC
  • PMG Research of Wilmington, LLC
  • Lillestol Research LLC
  • Diabetes & Endocrinology Associates of Stark County Inc
  • Sterling Research Group, Ltd
  • Rapid Medical Research, Inc.
  • Intend Clinical Research
  • Lynn Institute of Norman
  • Endocrinology Service Northwest LLC - Bend; Advanced Specialty Care (ASC) - Bend Office
  • Care Access Research, Warwick
  • Mountain View Clinical Research, Inc.
  • Carolina Health Specialist
  • Meridian Clinical Research
  • Holston Medical Group
  • University Diabetes & Endocrine Consultants
  • WR Clinsearch, LLC
  • Omega Research Nashville, LLC
  • Vanderbilt University Medical Center
  • Amarillo Medical Specialists
  • Texas Diabetes & Endocrinology
  • North Texas Endocrine Center
  • Research Institute of Dallas
  • Baylor Research Institute
  • UT Southwestern Medical Center Division of Endocrinology
  • UT Southwestern Medical Center
  • Academy of Diabetes Thyroid and Endocrine
  • Diabetes and Thyroid Center of Fort Worth
  • Victorium Clinical Research
  • Juno Research, LLC
  • Endocrine IPS, PLLC
  • Clinova Clinical Trials
  • Biopharma Informatic, LLC
  • Dr.Amir Ali Hassan, MD Off of
  • North Hills Medical Research, Inc.
  • Clinical Trials of Texas, Inc
  • Science Advancing Medicine (Sam) Clinical Research
  • Victorium Clinical Research
  • Northeast Clinical Research, LLC
  • Consano Clinical Research
  • DM Clinical Research
  • Bay Area Metabolic Health
  • Wasatch Clinical Research,LLC
  • Dr.David Gorson Md, Office Of
  • Manassas Clinical Research Center
  • Dr. Larry D. Stonesifer,MD,Office Of
  • Multicare Health System Research Institute
  • The Vancouver Clinic, Inc. PS

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

MYL-1601D Product (100 U/mL)

FlexPen NovoLog® (100 U/mL)

Arm Description

Outcomes

Primary Outcome Measures

Treatment Emergent Antibody Response (TEAR)
The number of subjects who were TEAR positive. TEAR is defined as either one of the following: Subjects who are Anti-Drug Antibody (ADA) negative at baseline and become positive at any timepoint post baseline Subjects who are ADA positive at baseline and demonstrate 4-fold increase in titer values at any timepoint post baseline visit.

Secondary Outcome Measures

Change in HbA1c From Baseline
Mean (SD) change from baseline HbA1c at Week 24.
Change in Fasting Plasma Glucose From Baseline
Mean (SD) change from baseline plasma glucose at Week 24.
Change in Prandial Insulin Dose From Baseline
Mean (SD) change from baseline daily mealtime insulin dose at Week 24.
Change in Basal Insulin Dose From Baseline
Mean (SD) change from baseline total daily insulin dose at Week 24.
Change in Total Daily Insulin Dose From Baseline
Mean (SD) change from baseline total daily insulin dose at Week 24
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

Full Information

First Posted
November 21, 2018
Last Updated
February 23, 2022
Sponsor
Mylan Inc.
Collaborators
Mylan GmbH
search

1. Study Identification

Unique Protocol Identification Number
NCT03760068
Brief Title
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

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
November 7, 2018 (Actual)
Primary Completion Date
December 28, 2019 (Actual)
Study Completion Date
January 17, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mylan Inc.
Collaborators
Mylan GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
478 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MYL-1601D Product (100 U/mL)
Arm Type
Active Comparator
Arm Title
FlexPen NovoLog® (100 U/mL)
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
MYL-1601D Product
Intervention Description
(100 U/mL)
Intervention Type
Drug
Intervention Name(s)
FlexPen NovoLog®
Intervention Description
(100 U/mL)
Primary Outcome Measure Information:
Title
Treatment Emergent Antibody Response (TEAR)
Description
The number of subjects who were TEAR positive. TEAR is defined as either one of the following: Subjects who are Anti-Drug Antibody (ADA) negative at baseline and become positive at any timepoint post baseline Subjects who are ADA positive at baseline and demonstrate 4-fold increase in titer values at any timepoint post baseline visit.
Time Frame
Baseline to week 24
Secondary Outcome Measure Information:
Title
Change in HbA1c From Baseline
Description
Mean (SD) change from baseline HbA1c at Week 24.
Time Frame
Baseline to week 24
Title
Change in Fasting Plasma Glucose From Baseline
Description
Mean (SD) change from baseline plasma glucose at Week 24.
Time Frame
Baseline to week 24
Title
Change in Prandial Insulin Dose From Baseline
Description
Mean (SD) change from baseline daily mealtime insulin dose at Week 24.
Time Frame
Baseline to week 24
Title
Change in Basal Insulin Dose From Baseline
Description
Mean (SD) change from baseline total daily insulin dose at Week 24.
Time Frame
Baseline to week 24
Title
Change in Total Daily Insulin Dose From Baseline
Description
Mean (SD) change from baseline total daily insulin dose at Week 24
Time Frame
Baseline to week 24
Title
Change in 7-point Self-monitored Blood Glucose (SMBG) Profile From Baseline
Description
Mean (SD) change in 7-point SMBG profile from baseline to Week 24
Time Frame
Baseline to week 24

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36114990
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.
Results Reference
derived

Learn more about this trial

Mylan Insulin Aspart Study

We'll reach out to this number within 24 hrs