Mylan Insulin Aspart Study

Diabetes Mellitus, Type 1 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03760068
• Other study ID #: MYL-1601D-3001
• Status: Completed
• Phase: Phase 3
• Start date: November 7, 2018
• Est. completion date: January 17, 2020

Study information

• Verified date: February 2022
• Source: Viatris Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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 information / eligibility

• Status: Completed
• Enrollment: 478
• Est. completion date: January 17, 2020
• Est. primary completion date: December 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• MYL-1601D Product
(100 U/mL)
• FlexPen NovoLog®
(100 U/mL)

Locations

Country	Name	City	State
United States	Albany Medical College	Albany	New York
United States	Amarillo Medical Specialists	Amarillo	Texas
United States	Northwest Endo Diabets Res.LLC	Arlington Heights	Illinois
United States	Mountain Diabetes	Asheville	North Carolina
United States	Atlanta Diabetes Associates	Atlanta	Georgia
United States	Barbara Davis Center for Diabetes	Aurora	Colorado
United States	Texas Diabetes & Endocrinology	Austin	Texas
United States	Model Clinical Research	Baltimore	Maryland
United States	Endocrinology Service Northwest LLC - Bend; Advanced Specialty Care (ASC) - Bend Office	Bend	Oregon
United States	Dr.David Gorson Md, Office Of	Bennington	Vermont
United States	Billings Clinic Research Center	Billings	Montana
United States	Boston University School Of Medicine	Boston	Massachusetts
United States	Meridien Research	Bradenton	Florida
United States	Holston Medical Group	Bristol	Tennessee
United States	NY Scientific	Brooklyn	New York
United States	Mercury Street Medical Group, PLLC	Butte	Montana
United States	Diabetes & Endocrinology Associates of Stark County Inc	Canton	Ohio
United States	University Diabetes & Endocrine Consultants	Chattanooga	Tennessee
United States	WR Clinsearch, LLC	Chattanooga	Tennessee
United States	Diabetes & Endocrinology Specialists, Inc.	Chesterfield	Missouri
United States	Sterling Research Group, Ltd	Cincinnati	Ohio
United States	Rapid Medical Research, Inc.	Cleveland	Ohio
United States	IACT Health	Columbus	Georgia
United States	John Muir Physician Network	Concord	California
United States	Hi Tech and Global Research, LLC	Coral Gables	Florida
United States	West Broadway Clinic	Council Bluffs	Iowa
United States	Midwest Endocrinology	Crystal Lake	Illinois
United States	Meridian Clinical Research	Dakota Dunes	South Dakota
United States	Baylor Research Institute	Dallas	Texas
United States	North Texas Endocrine Center	Dallas	Texas
United States	Research Institute of Dallas	Dallas	Texas
United States	UT Southwestern Medical Center	Dallas	Texas
United States	UT Southwestern Medical Center Division of Endocrinology	Dallas	Texas
United States	Creekside Endocrine Associates, PC	Denver	Colorado
United States	Moonshine Research Center, Inc.	Doral	Florida
United States	Academy of Diabetes Thyroid and Endocrine	El Paso	Texas
United States	Lillestol Research LLC	Fargo	North Dakota
United States	Dr. Larry D. Stonesifer,MD,Office Of	Federal Way	Washington
United States	Northeast Research Institute	Fleming Island	Florida
United States	Elite Clinical Research	Flint	Michigan
United States	Diabetes and Thyroid Center of Fort Worth	Fort Worth	Texas
United States	Valley Research	Fresno	California
United States	New West Physicians	Golden	Colorado
United States	Northwell Health	Great Neck	New York
United States	Marin Endocrine Care & Research, Inc.	Greenbrae	California
United States	Medication Management, LLC	Greensboro	North Carolina
United States	Physician's East, PA	Greenville	North Carolina
United States	Mountain View Clinical Research, Inc.	Greer	South Carolina
United States	Eastern Research, Inc.	Hialeah	Florida
United States	Biopharma Informatic, LLC	Houston	Texas
United States	Clinova Clinical Trials	Houston	Texas
United States	Dr.Amir Ali Hassan, MD Off of	Houston	Texas
United States	Endocrine IPS, PLLC	Houston	Texas
United States	Juno Research, LLC	Houston	Texas
United States	Victorium Clinical Research	Houston	Texas
United States	Diabetes/Lipid Management and Research Center	Huntington Beach	California
United States	Rocky Mountain Diabetes And Osteoporosis Center	Idaho Falls	Idaho
United States	East Coast Institute for Research, LLC	Jacksonville	Florida
United States	Jefferson City Medical Group (Jcmg) - Jcmg Medical Building	Jefferson City	Missouri
United States	American Research, LLC	Jeffersonville	Indiana
United States	Glacier View Research Institute - Endocrinology	Kalispell	Montana
United States	Care Research Center, Inc	Kendall	Florida
United States	Diabetes And Endocrine Associates	La Mesa	California
United States	Meridien Research	Lakeland	Florida
United States	Palm Research Center, Inc.	Las Vegas	Nevada
United States	Scott Research,Inc	Laurelton	New York
United States	Physicians Research Associates, LLC	Lawrenceville	Georgia
United States	Kentucky Diabetes And Endocrinology Center	Lexington	Kentucky
United States	Veterans Affairs Medical Center	Lexington	Kentucky
United States	Medical Investigations Inc.	Little Rock	Arkansas
United States	Long Beach Center For Clinical Research	Long Beach	California
United States	Office of Richard S. Cherlin, M.D	Los Gatos	California
United States	The Jones Center for Diabetes and Endrocrine Wellness	Macon	Georgia
United States	Central Florida Endocrine & Diabetes Consultants	Maitland	Florida
United States	Meridien Research	Maitland	Florida
United States	Manassas Clinical Research Center	Manassas	Virginia
United States	Advanced Clinical Research	Meridian	Idaho
United States	Crescent City Clinical Research Center, LLC	Metairie	Louisiana
United States	Baptist Diabetes Associates, Pa	Miami	Florida
United States	Cordova Research Institute	Miami	Florida
United States	DL Research Solutions Inc	Miami	Florida
United States	Dr. De Armas Research Center, LLC	Miami	Florida
United States	Life Spring Research Foundation	Miami	Florida
United States	Medi Clear Medical & Research Center, Inc	Miami	Florida
United States	P & S Research, LLC	Miami	Florida
United States	Pharmax Research Clinic, Inc.	Miami	Florida
United States	Phoenix Medical Research LLC	Miami	Florida
United States	Quality Professional Healthcare	Miami	Florida
United States	Inpatient Research Clinic	Miami Lakes	Florida
United States	Winthrop-University Hospital, Clinical Trials Center	Mineola	New York
United States	Endocrinology Associates Montgomery	Montgomery	Alabama
United States	Carteret Medical Group	Morehead City	North Carolina
United States	Lucas Research, Inc.	Morehead City	North Carolina
United States	Carolina Health Specialist	Myrtle Beach	South Carolina
United States	Southern New Hampshire Diabetes and Endocrinology	Nashua	New Hampshire
United States	Omega Research Nashville, LLC	Nashville	Tennessee
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	North Shore Diabetes and Endocrine Associates	New Hyde Park	New York
United States	Endocrine Associates of West Village	New York	New York
United States	Manhattan Medical Research Practice	New York	New York
United States	The Rose Salter Medical Research Foundation	Newport Beach	California
United States	Intend Clinical Research	Norman	Oklahoma
United States	Lynn Institute of Norman	Norman	Oklahoma
United States	Providence Clinical Research	North Hollywood	California
United States	North Hills Medical Research, Inc.	North Richland Hills	Texas
United States	California Medical Research Associates Inc	Northridge	California
United States	Pacific Reserach Partners	Oakland	California
United States	Alegent Health Research Center	Omaha	Nebraska
United States	Diabetes & Endocrine Associates, PC Research Center	Omaha	Nebraska
United States	Clinical Neurosciecne Solutions, Inc. dba CNS Healthcare	Orlando	Florida
United States	Omega Research Maitland, LLC	Orlando	Florida
United States	Ribo Research, LLC dba Peninsula Research, Inc	Ormond Beach	Florida
United States	Overland Park Surgical Specialties, LLC d/b/a College Park Family Care Center Physicians Group	Overland Park	Kansas
United States	Suncoast Clinical Research Inc.	Palm Harbor	Florida
United States	Palmtree Clinical Research, Inc.	Palm Springs	California
United States	In-Quest Medical Research, LLC	Peachtree Corners	Georgia
United States	Phoenician Centers for Research	Phoenix	Arizona
United States	Precision Trials	Phoenix	Arizona
United States	Western Univ of Health Science	Pomona	California
United States	Hanson Clinical Research Center	Port Charlotte	Florida
United States	Progressive Medical Research	Port Orange	Florida
United States	Medication Management, LLC	Raleigh	North Carolina
United States	Northern Nevada Endocrinology	Reno	Nevada
United States	Endocrine Research Solutions, Inc.	Roswell	Georgia
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Meridien Research	Saint Petersburg	Florida
United States	Wasatch Clinical Research,LLC	Salt Lake City	Utah
United States	Clinical Trials of Texas, Inc	San Antonio	Texas
United States	Science Advancing Medicine (Sam) Clinical Research	San Antonio	Texas
United States	Victorium Clinical Research	San Antonio	Texas
United States	Mills-Peninsula Health Services Diabetes Research Institute	San Mateo	California
United States	NorCal Endocrinology and Internal Medicine	San Ramon	California
United States	Sansum Diabetes Research Institute	Santa Barbara	California
United States	Coastal Biomedical Research, Inc.	Santa Monica	California
United States	Northeast Clinical Research, LLC	Schertz	Texas
United States	Consano Clinical Research	Shavano Park	Texas
United States	NorthShore University Health System	Skokie	Illinois
United States	Multicare Health System Research Institute	Spokane	Washington
United States	Meridien Research	Spring Hill	Florida
United States	Mercy Research	Springfield	Missouri
United States	Meridien Research	Tampa	Florida
United States	The Metabolic Institute Of America (Mioa Inc)	Tarzana	California
United States	DM Clinical Research	Tomball	Texas
United States	Cotton O'Neil Clinical Research Ctr	Topeka	Kansas
United States	Professional Clinical Research	Traverse City	Michigan
United States	Diabetes Research Center	Tustin	California
United States	The Vancouver Clinic, Inc. PS	Vancouver	Washington
United States	Dr.Ronald H. Chochinov MD,Office Of	Ventura	California
United States	Diablo Clinical Research, Inc.	Walnut Creek	California
United States	MassResearch	Waltham	Massachusetts
United States	Care Access Research, Warwick	Warwick	Rhode Island
United States	Bay Area Metabolic Health	Webster	Texas
United States	Asclepes Research Centers	Weeki Wachee	Florida
United States	Iowa Diabetes and Endocrinology Research Center (IDERC)	West Des Moines	Iowa
United States	Metabolic Research Institute, Inc.	West Palm Beach	Florida
United States	Paradigm Research	Wheat Ridge	Colorado
United States	PMG Research of Wilmington, LLC	Wilmington	North Carolina
United States	Dr. Jonas Leibowitz MD, Office Of	Yonkers	New York

Sponsors (2)

Lead Sponsor	Collaborator
Mylan Inc.	Mylan GmbH

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline to week 24
Secondary	Change in HbA1c From Baseline	Mean (SD) change from baseline HbA1c at Week 24.	Baseline to week 24
Secondary	Change in Fasting Plasma Glucose From Baseline	Mean (SD) change from baseline plasma glucose at Week 24.	Baseline to week 24
Secondary	Change in Prandial Insulin Dose From Baseline	Mean (SD) change from baseline daily mealtime insulin dose at Week 24.	Baseline to week 24
Secondary	Change in Basal Insulin Dose From Baseline	Mean (SD) change from baseline total daily insulin dose at Week 24.	Baseline to week 24
Secondary	Change in Total Daily Insulin Dose From Baseline	Mean (SD) change from baseline total daily insulin dose at Week 24	Baseline to week 24
Secondary	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	Baseline to week 24