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
NCT ID: NCT03596450
Last Updated: 2024-07-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
1278 participants
INTERVENTIONAL
2018-07-13
2023-06-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Semaglutide
Participants will receive semaglutide subcutaneously (s.c.) in addition to metformin monotherapy as treatment intensification in the course of routine clinical practice. Participants will be followed for 2 years, regardless of changes in antidiabetic treatment over the course of the study.
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 in addition to metformin monotherapy as treatment intensification in the course of routine clinical practice. Participants will be followed for 2 years, regardless of changes in antidiabetic treatment over the course of the study.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Male or female, age 18 years or older at the time of signing informed consent.
* Type 2 diabetes mellitus diagnosis.
* Treatment with either 1 or 2 oral antidiabetic medications.
* Current member of a commercial or Medicare health plan with pharmacy benefits.
* Recorded HbAlc value within the last 90 days prior to randomization.
* Further intensification with an additional antidiabetic oral or injectable medication is indicated to achieve glycemic target at the discretion of the study physician according to approved labelling.
Exclusion Criteria
* Treatment with more than 2 oral antidiabetic medications, oral semaglutide, or any injectable medication in a period of 30 days before the day of eligibility assessment. Temporary/emergency use of any type of insulin is allowed, as is prior insulin treatment for gestational diabetes.
* Contraindications to semaglutide according to the Food and Drug Administration approved label.
* Female who is pregnant, breastfeeding or intends to become pregnant
* Participation in another clinical trial.
18 Years
65 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Reporting Anchor and Disclosure (1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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American Clinical Trials
Buena Park, California, United States
St. Jos Heritage Hlthcr_Fllrtn
Fullerton, California, United States
SC Clinical Research, Inc.
Garden Grove, California, United States
New Hope Consulting & Clinical Trials
Lancaster, California, United States
OM Research LLC
Lancaster, California, United States
Pacific Clinical Studies
Los Alamitos, 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
Format Medical Research
Oxnard, California, United States
Joselito C Cabaccan, MD
San Jose, 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
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
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
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
St. Vincent Research Institute
Anderson, Indiana, United States
American Health Network of Indiana, LLC_Avon_0
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
La Porte County Institute For Clinical Research
Michigan City, Indiana, United States
Beacon Medical Group Swartz-Weikamp
Mishawaka, Indiana, United States
American Health Network of IN LLC
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
The Endocrine & Diabetes Center
Owensboro, Kentucky, United States
Paris Family Physicians PLLC
Paris, Kentucky, United States
Gaurang B. Shah, MD
Richmond, Kentucky, United States
WCMP Family Medicine
Belfast, Maine, 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
Palm Research Center Inc-Vegas
Las Vegas, Nevada, United States
Albany Medical College - Endo
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
NYC Research, Inc.
New York, New York, United States
NYU Grossman School of Med
New York, 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
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 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
Franklin Family Practice
Franklin, Ohio, United States
Prestige Clinical Research
Franklin, Ohio, United States
Functional Endocrinology
Mason, Ohio, United States
New Venture Medical Research
Wadsworth, Ohio, United States
Harleysville Medical Associates
Harleysville, Pennsylvania, United States
Primary Care Research South, Inc
McMurray, 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
Christus Trinity Clinic Hill Country Landa
New Braunfels, 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
Hampton Family Practice
Hampton, Virginia, United States
Medical Associates of Central Virginia, Inc.
Lynchburg, Virginia, United States
C. Lee Ginsburgh
Newport News, Virginia, United States
Family Medicine Healthcare
Portsmouth, Virginia, United States
Family Health Clinic
Radford, Virginia, United States
Halifax Internal Medicine
South Boston, 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
Family Care of Williamsburg
Williamsburg, 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
Countries
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References
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Buse JB, Nordahl Christensen H, Harty BJ, Cziraky MJ, Willey VJ, Skibsted S. Long-term comparative effectiveness of once-weekly semaglutide versus alternative treatments in a real-world US adult population with type 2 diabetes: a randomized pragmatic clinical trial. BMJ Open Diabetes Res Care. 2025 Oct 15;13(5):e005161. doi: 10.1136/bmjdrc-2025-005161.
Buse JB, Nordahl Christensen H, Harty BJ, Mitchell J, Soule BP, Zacherle E, Cziraky M, Willey VJ. Study design and baseline profile for adults with type 2 diabetes in the once-weekly subcutaneous SEmaglutide randomized PRAgmatic (SEPRA) trial. BMJ Open Diabetes Res Care. 2023 May;11(3):e003206. doi: 10.1136/bmjdrc-2022-003206.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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U1111-1207-6474
Identifier Type: OTHER
Identifier Source: secondary_id
NN9535-4416
Identifier Type: -
Identifier Source: org_study_id
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