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Long Term Comparative Effectiveness of Once Weekly Semaglutide Versus Standard of Care in a Real World Adult US Population With Type 2 Diabetes - a Randomized Pragmatic Trial
Sponsor: Novo Nordisk A/S
Summary
The main purpose of this study is to compare the effects of semaglutide (Ozempic®) with the effects of other treatments for type 2 diabetes in a normal practice setting. The participant will be assigned by chance (like flipping a coin) to one of the following treatment groups: Group 1: semaglutide (Ozempic®) (by injection into skin) Group 2: standard of care antidiabetic medication (oral or injectable). The participant has an equal chance of being in either of the treatment groups. Neither the participant nor the study doctor or study staff will be able to pick which group the participant is in, but the participant will know which study drug the participant has been assigned to. The study doctor will provide the participant with a prescription for the study diabetes medication based on the treatment group the participant is assigned. The participation will last about 2 years.
Official title: Long Term Comparative Effectiveness of Once Weekly Semaglutide Versus Standard of Care in a Real World Adult US Population With Type 2 Diabetes - a Randomized Pragmatic Clinical Trial
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
1278
Start Date
2018-07-13
Completion Date
2023-06-09
Last Updated
2026-09-30
Healthy Volunteers
No
Conditions
Interventions
Semaglutide
Participants will be prescribed commercially available semaglutide s.c. and will be instructed to initiate treatment with semaglutide s.c. according to the approved label. The study doctor will determine the intended maintenance dose of semaglutide, as well as changes to the maintenance dose thereafter.
Standard of care
Participants will receive standard of care, defined as commercially available oral or injectable antidiabetic medication other than semaglutide. Participants will be prescribed and instructed to initiate commercially available antidiabetic medication according to the approved label and, if relevant for the specific antidiabetic medication, adjusted at the discretion of the study doctor.
Locations (181)
American Clinical Trials
Buena Park, California, United States
Endocrine Specialty Consultant Inc.
Burbank, California, United States
FDRC
Costa Mesa, California, United States
Bay Area Clinical Research
Dublin, California, United States
Providence Medical Foundation
Fullerton, California, United States
SC Clinical Research, Inc.
Garden Grove, California, United States
SCKE Odyssey Medical Group
Laguna Hills, California, United States
New Hope Consulting & Clinical Trials
Lancaster, California, United States
OM Research LLC
Lancaster, California, United States
Torrance Clin Res Inst, Inc.
Lomita, California, United States
West Coast Endocrine, Inc.
Long Beach, California, United States
Pacific Clinical Studies
Los Alamitos, California, United States
Angel City Research
Los Angeles, California, United States
University of Californ LA-UCLA
Los Angeles, California, United States
Patel, Rahul
Manteca, California, United States
Pacific Medical Center
Milpitas, California, United States
Facey Medical Foundation
Mission Hills, California, United States
Monterey Endocrine & Diabetes Institute, Inc
Monterey, California, United States
Do-Eun Lee
Napa, California, United States
Charles Andrews, MD
Newport Beach, California, United States
Hoag Medical Group
Newport Beach, California, United States
Adam B. Sherman D O Professional Corp.
Oxnard, California, United States
Format Medical Research
Oxnard, California, United States
Stanford Univ School of Med
Palo Alto, California, United States
Posada, Juan
San Jose, California, United States
Joselito C Cabaccan, MD
San Jose, California, United States
Care Access Research Santa Clarita
Santa Clarita, California, United States
Premier Medical Center, Inc.
Toluca Lake, California, United States
Adnab Research/Prestige Care Physician
Torrance, California, United States
Altura Centers For Health
Tulare, California, United States
Tariq Javed, MD Inc.
Visalia, California, United States
Endocrinology & Diabetes Specialists
Walnut Creek, California, United States
PIH Health Physicians Endocrinology
Whittier, California, United States
Optumcare Clinical Trials,LLC-Golden
Colorado Springs, Colorado, United States
Delta Waves, Inc.
Colorado Springs, Colorado, United States
University of Colorado Hospital
Denver, Colorado, United States
Denver Endocrinology Diabetes and Thyroid Center
Englewood, Colorado, United States
ProHealth Physicians/OptumCare
Bristol, Connecticut, United States
Western Connecticut Health Network_Danbury
Danbury, Connecticut, United States
Endocrine Associates of Connecticut
Hamden, Connecticut, United States
Ismail Tarkhan MD
Milford, Connecticut, United States
Steven L. Saunders MD LLC
Milford, Connecticut, United States
Westside Center For Clinical Research
Jacksonville, Florida, United States
The Kaufmann Clinic, Inc.
Atlanta, Georgia, United States
Primary Care Research
Atlanta, Georgia, United States
Southern Family Medical Center
Augusta, Georgia, United States
River Birch Research Alliance, LLC
Blue Ridge, Georgia, United States
Gwinnett Research Insti/Buford Family Pract Urgent Care Ctr
Buford, Georgia, United States
Centricity Research
Columbus, Georgia, United States
Medical Care of LaGrange
La Grange, Georgia, United States
Beaver Ruin Primary Care
Lilburn, Georgia, United States
Privia Medical Group of Georgia LLC
Locust Grove, Georgia, United States
DC Research Works
Marietta, Georgia, United States
Urban Family Practice Assoc
Marietta, Georgia, United States
Atlanta Center for Clinical Research
Roswell, Georgia, United States
Sandersville Family Practice
Sandersville, Georgia, United States
Meridian Clin Res, LLC
Savannah, Georgia, United States
Family Health Care Center
Statesboro, Georgia, United States
Eagles Landing Diabetes/Endocrinology
Stockbridge, Georgia, United States
First Medical Research Center
Stone Mountain, Georgia, United States
Herman Clinical Research LLC
Suwanee, Georgia, United States
Sugarloaf Medical, PC
Suwanee, Georgia, United States
East Georgia Healthcare Center Inc
Swainsboro, Georgia, United States
Coastal Care Medical Clinic
Waycross, Georgia, United States
Solaris Clinical Research
Meridian, Idaho, United States
St. Vincent Research Institute
Anderson, Indiana, United States
American Health Network of Indiana, LLC_Avon_0
Avon, Indiana, United States
Tom H. Jones
Avon, Indiana, United States
Adams County Family Physicians
Berne, Indiana, United States
Deaconess Clinic, Inc.
Evansville, Indiana, United States
Associated Surgeons & Physicians LLC
Fort Wayne, Indiana, United States
American Health Network of IN LLC_Franklin
Franklin, Indiana, United States
American Health Network of Indiana, LLC_Greenfield
Greenfield, Indiana, United States
Indiana Internal Medicine Consultants LLC
Greenwood, Indiana, United States
La Porte County Institute For Clinical Research
Michigan City, Indiana, United States
Beacon Medical Group Swartz-Weikamp
Mishawaka, Indiana, United States
Indiana University Health Ball Memorial Hospital
Muncie, Indiana, United States
American Health Network of IN LLC
Muncie, Indiana, United States
Elpidio M. Feliciano
Muncie, Indiana, United States
American Health Network of Indiana, LLC
New Albany, Indiana, United States
Reid Endocrinology Center
Richmond, Indiana, United States
Regional Endorine and Diabetes Associates
Ashland, Kentucky, United States
Tri State Primary Caregrayson Health Park
Ashland, Kentucky, United States
St Elizabeth Physicians Heart
Covington, Kentucky, United States
Patel Medical Center
Irvington, Kentucky, United States
The Endocrine & Diabetes Center
Owensboro, Kentucky, United States
Paris Family Physicians PLLC
Paris, Kentucky, United States
Gaurang B. Shah, MD
Richmond, Kentucky, United States
Versailles Family Medicine
Versailles, Kentucky, United States
WCMP Family Medicine
Belfast, Maine, United States
MD Medical Research
Oxon Hill, Maryland, United States
Tri-County Research, Inc.
Sterling Heights, Michigan, United States
Diabetes & Endo Specialists Inc
Chesterfield, Missouri, United States
University Of Missouri - Columbia
Columbia, Missouri, United States
Jefferson City Medical Group, PC
Jefferson City, Missouri, United States
Trinity Healthcare
Springfield, Missouri, United States
Saint Louis University
St Louis, Missouri, United States
South County Endocrinology and Obesity Medicine, LLC
St Louis, Missouri, United States
Desert Endocrinology Clinical Research Center
Las Vegas, Nevada, United States
Palm Research Center Inc-Vegas
Las Vegas, Nevada, United States
Southern New Hampshire Diabete
Nashua, New Hampshire, United States
AMC Community Endocrinology
Albany, New York, United States
Prominis Medical Services PC
Brooklyn, New York, United States
Northwell Health Div of Endo
Great Neck, New York, United States
Advanced Internal Medicine Group
Great Neck, New York, United States
Smart Medical Research Inc.
Jackson Heights, New York, United States
Rockcastle Family Endocrinology
Mount Vernon, New York, United States
NYC Research, Inc.
New York, New York, United States
NYU Grossman School of Med
New York, New York, United States
Elligo Health Research Inc
New York, New York, United States
Endocrine Associates of Long Island, PC
Smithtown, New York, United States
EDOC LLP
Yonkers, New York, United States
OnSite Clinical Solutions, LLC_Charlotte_0
Charlotte, North Carolina, United States
OnSite Clinical Solutions, LLC_Charlotte
Charlotte, North Carolina, United States
Burke Primary Care
Morganton, North Carolina, United States
Lillestol Research LLC
Fargo, North Dakota, United States
Valley Weight Loss Clinic
Fargo, North Dakota, United States
Catherine LaRuffa, M.D., Inc.
Blanchester, Ohio, United States
Diab & Endo Assoc of Stark Co
Canton, Ohio, United States
Medical Frontiers, LLC
Carlisle, Ohio, United States
University of Cincinnati/UC Health
Cincinnati, Ohio, United States
University Hospitals of Cleveland Case Medical Center
Cleveland, Ohio, United States
Central Ohio Clinical Research LLC
Columbus, Ohio, United States
Centricity Research
Columbus, Ohio, United States
Providence Health Partners Ctr
Dayton, Ohio, United States
Franklin Family Practice
Franklin, Ohio, United States
Prestige Clinical Research
Franklin, Ohio, United States
Albert J Weisbrot
Mason, Ohio, United States
Functional Endocrinology
Mason, Ohio, United States
Toledo Clinic
Toledo, Ohio, United States
New Venture Medical Research
Wadsworth, Ohio, United States
Harleysville Medical Associates
Harleysville, Pennsylvania, United States
Detweiler Family Med
Lansdale, Pennsylvania, United States
Primary Care Research South, Inc
McMurray, Pennsylvania, United States
Master Centre for USA
Pittsburgh, Pennsylvania, United States
Preferred Primary Care Physicians_Pittsburgh
Pittsburgh, Pennsylvania, United States
Athens Medical Group
Athens, Tennessee, United States
PMG Research of Bristol
Bristol, Tennessee, United States
Murphy Research Center
Humboldt, Tennessee, United States
Ascend Research Centers, Inc.
McMinnville, Tennessee, United States
Rockwood Medical Clinic
Fort Worth, Texas, United States
TVC Clinical Research
Gonzales, Texas, United States
PrimeCare Medical Group
Houston, Texas, United States
Southwest Urgent Care and Family practice
Houston, Texas, United States
Christus Trinity Clinic Hill Country Landa
New Braunfels, Texas, United States
Hill Country Medical Associates
New Braunfels, Texas, United States
HAS Research
San Antonio, Texas, United States
Simcare Medical Research, LLC
Sugar Land, Texas, United States
Chrysalis Clinical Research
St. George, Utah, United States
The Endocrinology Group
Arlington, Virginia, United States
Chatham Family Medical Center
Chatham, Virginia, United States
Swift Creek Family Care
Colonial Heights, Virginia, United States
Lawson Family Medicine & Aesthetics
Daleville, Virginia, United States
Privia Medical Group LLC
Danville, Virginia, United States
Seven Corners Medical
Falls Church, Virginia, United States
Courtside Family Medicine PLLC
Gloucester, Virginia, United States
Hampton Family Practice
Hampton, Virginia, United States
Hartford Internal Medicine
Hampton, Virginia, United States
Medical Associates of Central Virginia, Inc.
Lynchburg, Virginia, United States
Virginia Research Center
Midlothian, Virginia, United States
C. Lee Ginsburgh
Newport News, Virginia, United States
York Clinical Research LLC
Norfolk, Virginia, United States
Eastern Virginia Medical School
Norfolk, Virginia, United States
Clinical Research Partners
North Chesterfield, Virginia, United States
Family Medicine Healthcare
Portsmouth, Virginia, United States
Family Health Clinic
Radford, Virginia, United States
Dominion Medical Associates
Richmond, Virginia, United States
Halifax Internal Medicine
South Boston, Virginia, United States
Southside Primary Care
South Chesterfield, Virginia, United States
Colonial Medical Clinic
South Chesterfield, Virginia, United States
Hampton Roads Center for Clinical Research
Suffolk, Virginia, United States
Endocrinology Consultants
Virginia Beach, Virginia, United States
Corporation Lane Research Center
Virginia Beach, Virginia, United States
Piedmont Family Practice PLC
Warrenton, Virginia, United States
Tidewater Physicians Multispecialty Group
Williamsburg, Virginia, United States
Family Care of Williamsburg
Williamsburg, Virginia, United States
Selma Medical Associates
Winchester, Virginia, United States
St. Vincent Hosp-Prevea Health
Green Bay, Wisconsin, United States
Ascension Medical Group- Germantown Clinic
Milwaukee, Wisconsin, United States
Medical College of Wisconsin & Zablocki VAMC
Milwaukee, Wisconsin, United States
Western University Medical Center at WU of Health Sciences
London, Ontario, Canada