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En forskningsundersøgelse for at se på, hvordan Semaglutid sammen med en lavere dosis insulin Glargin sammenligner med en højere dosis insulin Glargin alene hos mennesker med type 2-diabetes (SUSTAIN OPTIMIZE)

17. april 2026 opdateret af: Novo Nordisk A/S

Effekt og sikkerhed af Semaglutid S.C. 2,0 mg én gang om ugen som tilføjelse til dosisreduceret Insulin Glargine vs. titreret Insulin Glargine hos deltagere med type 2-diabetes og overvægt

Denne undersøgelse sammenligner semaglutid sammen med en lavere dosis insulin glargin med en højere dosis insulin glargin hos deltagere med type 2-diabetes. Undersøgelsen ser på, hvor godt undersøgelsesmedicinen kontrollerer blodsukkerniveauet. Deltagerne vil enten få semaglutid sammen med en lavere dosis insulin glargin eller en højere dosis insulin glargin. Undersøgelsen vil vare i omkring 47 uger (ca. 11 måneder). Deltagerne får 9 klinikbesøg, 15 telefon-/videoopkald og 1 hjemmebesøg. Deltagerne vil blive bedt om at bære en sensor, der måler deres blodsukker hele tiden i 2 perioder af 10 dage under undersøgelsen.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

573

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Alabama
      • Sheffield, Alabama, Forenede Stater, 35660
        • Shoals Primary Care
    • Arizona
      • Glendale, Arizona, Forenede Stater, 85308
        • Lenzmeier Fam Med CCT Research
      • Mesa, Arizona, Forenede Stater, 85213
        • Synexus Clinical Research US, Inc./Desert Clinical Research,
    • Arkansas
      • Searcy, Arkansas, Forenede Stater, 72143
        • Unity Health-Searcy Medical Center
      • Searcy, Arkansas, Forenede Stater, 72143
        • OneLife Direct Care Inc.
    • California
      • Canoga Park, California, Forenede Stater, 91304
        • San Fernando Valley Hlth Inst, LLC
      • Chula Vista, California, Forenede Stater, 91911
        • Velocity Clin Res-Chula Vista
      • Concord, California, Forenede Stater, 94520
        • John Muir Physicians Network
      • Fresno, California, Forenede Stater, 93720
        • Valley Research
      • Fullerton, California, Forenede Stater, 92835
        • Providence Medical Foundation
      • Fullerton, California, Forenede Stater, 92835
        • Ascada Research
      • Huntington Park, California, Forenede Stater, 90255
        • Velocity Clinical Research Huntington Park
      • La Jolla, California, Forenede Stater, 92037
        • Scripps Memorial Hospital La Jolla
      • La Mesa, California, Forenede Stater, 91942
        • Velocity Clin Res San Diego
      • Lancaster, California, Forenede Stater, 93534
        • First Valley Medical Group
      • Loma Linda, California, Forenede Stater, 92354
        • Loma Linda Univ Hlth Cr Endo
      • Lomita, California, Forenede Stater, 90717
        • Torrance Clin Res Inst, Inc.
      • Los Angeles, California, Forenede Stater, 90017
        • Downtown LA Res Ctr. Inc.
      • Los Angeles, California, Forenede Stater, 90015
        • NRC Research Institute
      • Los Angeles, California, Forenede Stater, 90017
        • Velocity Clin Res Los Angeles
      • Northridge, California, Forenede Stater, 91325
        • Valley Clinical Trials, Inc.
      • San Diego, California, Forenede Stater, 92120
        • Wetlin Research Associates, Inc.
      • San Diego, California, Forenede Stater, 92111
        • San Diego Family Care_San Diego
      • Tustin, California, Forenede Stater, 92780
        • University Clin Investigators
    • Colorado
      • Denver, Colorado, Forenede Stater, 80209
        • Velocity Clin Res, Denver
    • Connecticut
      • Waterbury, Connecticut, Forenede Stater, 06708
        • Chase Medical Research LLC
    • Florida
      • Hialeah, Florida, Forenede Stater, 33012
        • Indago Research & Health Center Inc.
      • Hollywood, Florida, Forenede Stater, 33024
        • Encore Medical Research LLC
      • Jacksonville, Florida, Forenede Stater, 32216
        • Jacksonville Ctr For Clin Res
      • Jacksonville, Florida, Forenede Stater, 32204
        • Northeast Res Inst. Inc.
      • Jacksonville, Florida, Forenede Stater, 32277
        • Care-Partners-Clinical-Research, LLC
      • Miami, Florida, Forenede Stater, 33165
        • New Horizon Research Center
      • Miami, Florida, Forenede Stater, 33135
        • Suncoast Research Group, LLC
      • Miami, Florida, Forenede Stater, 33175
        • Reyes Clinical Research, Inc
      • Miami, Florida, Forenede Stater, 33183
        • International Research Associates, LLC_Miami
      • Miami, Florida, Forenede Stater, 33169
        • Elite Research Center
      • Miami, Florida, Forenede Stater, 33175
        • Diverse Clinical Research Miami
      • Miramar, Florida, Forenede Stater, 33027
        • South Broward Research LLC
      • New Port Richey, Florida, Forenede Stater, 34652
        • Suncoast Clinical Research, Inc._New Port Richey
      • New Port Richey, Florida, Forenede Stater, 34652
        • Suncoast Clin Res Port Richey
      • Ocala, Florida, Forenede Stater, 34470
        • Renstar Medical Research
      • Tampa, Florida, Forenede Stater, 33607
        • Clinical Research Trials of Florida
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30329-4015
        • CVS Store Number: 7689
      • Canton, Georgia, Forenede Stater, 30114
        • East Coast Institute for Res
      • Hinesville, Georgia, Forenede Stater, 31313
        • Coastal Heritage Clinical Research
      • Macon, Georgia, Forenede Stater, 31210
        • East Coast Institute for Res
      • Roswell, Georgia, Forenede Stater, 30076
        • Endocrine Research Solutions
      • Savannah, Georgia, Forenede Stater, 31405-6901
        • CVS Store Number: 05520
    • Idaho
      • Meridian, Idaho, Forenede Stater, 83646
        • Solaris Clinical Research
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60607
        • Cedar-Crosse Research Center
      • Chicago, Illinois, Forenede Stater, 60661
        • WellNow Urgent Care
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46260
        • Brengle Family Medicine
    • Iowa
      • Council Bluffs, Iowa, Forenede Stater, 51501
        • West Broadway Clinic
      • West Des Moines, Iowa, Forenede Stater, 50265
        • Iowa Diab & Endo Res Center
      • West Des Moines, Iowa, Forenede Stater, 50266
        • Iowa Diab & Endo Res Center
    • Kansas
      • Topeka, Kansas, Forenede Stater, 66606
        • Cotton O'Neil Diab & Endo Ctr
    • Kentucky
      • Lexington, Kentucky, Forenede Stater, 40503
        • The Research Group of Lexington LLC
      • Louisville, Kentucky, Forenede Stater, 40213
        • L-MARC Research Center
    • Louisiana
      • Monroe, Louisiana, Forenede Stater, 71203
        • Arthritis And Diabetes Clinic, Inc.
      • New Orleans, Louisiana, Forenede Stater, 70119
        • AMR New Orleans
      • Slidell, Louisiana, Forenede Stater, 70461
        • Ileana J. Tandron, MD APMC (a private medical office)
    • Maryland
      • Hyattsville, Maryland, Forenede Stater, 20782
        • MedStar Hlth Res Institute
      • Rockville, Maryland, Forenede Stater, 20852
        • Endo And Metab Cons
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02215
        • Joslin Diabetes Center
      • Boston, Massachusetts, Forenede Stater, 02115
        • Brigham & Women's Hospital
    • Michigan
      • Buckley, Michigan, Forenede Stater, 49620
        • Northern Pines Hlth Ctr, PC
      • Detroit, Michigan, Forenede Stater, 48202
        • Henry Ford Health System
      • Flint, Michigan, Forenede Stater, 48532
        • Elite Research Center
      • Troy, Michigan, Forenede Stater, 48098
        • Arcturus HC PLC Troy Med Res
    • Missouri
      • City of Saint Peters, Missouri, Forenede Stater, 63303
        • StudyMetrix Research LLC
    • Montana
      • Butte, Montana, Forenede Stater, 59701
        • Mercury Str Med Grp, PLLC
    • Nebraska
      • Elkhorn, Nebraska, Forenede Stater, 68022
        • Clinical Research Advantage, Inc./Skyline Medical Center, PC
      • Fremont, Nebraska, Forenede Stater, 68025
        • Methodist Physicians Clinic
      • Norfolk, Nebraska, Forenede Stater, 68701
        • Velocity Clin Res, Norfolk
      • Omaha, Nebraska, Forenede Stater, 68144
        • Midwest Regional Health Services
      • Omaha, Nebraska, Forenede Stater, 68198-3020
        • Univ of Nebraska Medical CTR
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89128
        • Palm Research Center Inc-Vegas
    • New Hampshire
      • Nashua, New Hampshire, Forenede Stater, 03060
        • Southern New Hampshire Diabetes and Endocrinology
    • New Jersey
      • Trenton, New Jersey, Forenede Stater, 08611
        • Premier Research Inc.
    • New York
      • Albany, New York, Forenede Stater, 12203
        • AMC Community Endocrinology
      • Brooklyn, New York, Forenede Stater, 11229
        • Dr. Alexander Perkelvald
      • New Windsor, New York, Forenede Stater, 12553
        • Mid Hudson Med Res-New Windsor
      • Westfield, New York, Forenede Stater, 14787
        • Great Lakes Medical Research
    • North Carolina
      • Chapel Hill, North Carolina, Forenede Stater, 27514
        • University of North Carolina Medical Center
      • Greenville, North Carolina, Forenede Stater, 27834
        • Physicians East Endocrinology
      • Morehead City, North Carolina, Forenede Stater, 28557
        • Carteret Medical Group
      • Morehead City, North Carolina, Forenede Stater, 28557
        • Centricity Rsrch MHCity Multi
    • North Dakota
      • Fargo, North Dakota, Forenede Stater, 58104
        • Lillestol Research LLC
    • Ohio
      • Beachwood, Ohio, Forenede Stater, 44122
        • Velocity Clin Res Cleveland
      • Canton, Ohio, Forenede Stater, 44718
        • Diab & Endo Assoc of Stark Co
      • Cincinnati, Ohio, Forenede Stater, 45219
        • Velocity Clin Res_Cincinnati
      • Mason, Ohio, Forenede Stater, 45040
        • Albert J Weisbrot
      • Maumee, Ohio, Forenede Stater, 43537
        • Advanced Med Res Maumee
      • Toledo, Ohio, Forenede Stater, 43614
        • University of Toledo Medical Center
      • Toledo, Ohio, Forenede Stater, 43614
        • University of Toledo_Toledo
    • Oklahoma
      • Norman, Oklahoma, Forenede Stater, 73069
        • Lynn Institute of Norman
      • Norman, Oklahoma, Forenede Stater, 73069
        • Intend Research
    • Oregon
      • Medford, Oregon, Forenede Stater, 97504
        • Velocity Clinical Res Medford
    • Pennsylvania
      • Beaver, Pennsylvania, Forenede Stater, 15009
        • Heritage Valley Multispeciality Group Inc
      • Johnstown, Pennsylvania, Forenede Stater, 15905
        • Richard M Kastelic MD Assoc
      • Philadelphia, Pennsylvania, Forenede Stater, 19107
        • Thomas Jefferson University
      • Uniontown, Pennsylvania, Forenede Stater, 15401
        • Preferred Primary Care Physicians, Inc.
    • South Carolina
      • Myrtle Beach, South Carolina, Forenede Stater, 29572
        • Carolina Health Specialists
      • Summerville, South Carolina, Forenede Stater, 29485
        • Palmetto Clinical Research
    • Tennessee
      • Chattanooga, Tennessee, Forenede Stater, 37404
        • Chattanooga Medical Research, Llc
      • Chattanooga, Tennessee, Forenede Stater, 37411
        • Univ Diab & Endo Consultants
      • Jackson, Tennessee, Forenede Stater, 38305
        • Jackson Clinic
      • Kingsport, Tennessee, Forenede Stater, 37660
        • Holston Medical Group
      • Knoxville, Tennessee, Forenede Stater, 37938
        • Accellacare US Inc., d/b/a Accellacare of Knoxville
      • Memphis, Tennessee, Forenede Stater, 38119
        • Clinical Neuroscience Solutions
    • Texas
      • Amarillo, Texas, Forenede Stater, 79106
        • Amarillo Med Spec LLP
      • Arlington, Texas, Forenede Stater, 76012-4637
        • Arlington Family Res. Ctr Inc
      • Austin, Texas, Forenede Stater, 78705
        • Central Texas Clinical Research
      • Cedar Park, Texas, Forenede Stater, 78613
        • Velocity Clin Res Austin
      • Dallas, Texas, Forenede Stater, 75230
        • Velocity Clinical Res-Dallas
      • Dallas, Texas, Forenede Stater, 75208
        • Thyroid Endocrinology & Diabetes PA
      • El Paso, Texas, Forenede Stater, 79935
        • Academy of Diabetes, T&E
      • Fort Worth, Texas, Forenede Stater, 76132
        • Diabetes and Thyroid Ctr of FW
      • Houston, Texas, Forenede Stater, 77074
        • Houston Institute for Clinical Research
      • Houston, Texas, Forenede Stater, 77040
        • JCCT- Juno NW Houston
      • Houston, Texas, Forenede Stater, 77029
        • Gonzalez Family & Occupational Medicine
      • Hurst, Texas, Forenede Stater, 76054
        • Protenium Clinical Research
      • Longview, Texas, Forenede Stater, 75605
        • DCOL Ctr for Clin Res
      • McKinney, Texas, Forenede Stater, 75069
        • Tekton Research
      • Plano, Texas, Forenede Stater, 75075
        • Clinical Investigations of Texas
      • San Antonio, Texas, Forenede Stater, 78230
        • VIP Trials
      • San Antonio, Texas, Forenede Stater, 78224
        • Briggs Clinical Research, LLC
      • San Antonio, Texas, Forenede Stater, 78220
        • San Antonio Prem Int Med
      • San Antonio, Texas, Forenede Stater, 78229
        • Diabetes Glandular Diseases Clinic
      • San Antonio, Texas, Forenede Stater, 78240
        • Diabetes Glandular Diseases Clinic
      • Shavano Park, Texas, Forenede Stater, 78231
        • Consano Clinical Research, LLC
      • Sugar Land, Texas, Forenede Stater, 77479
        • Med-Olam Clinical Reseach LLC
      • Waco, Texas, Forenede Stater, 76708
        • Hillcrest Family Health Center
    • Utah
      • Ogden, Utah, Forenede Stater, 84405
        • Advanced Research Institute
      • Ogden, Utah, Forenede Stater, 84405
        • South Ogden Family Medicine/ CCT Research
      • Salt Lake City, Utah, Forenede Stater, 84117
        • Olympus Family Medicine
      • St. George, Utah, Forenede Stater, 84790
        • Chrysalis Clinical Research
      • West Jordan, Utah, Forenede Stater, 84088
        • Velocity Clin Res-Salt Lk City
    • Virginia
      • Chesapeake, Virginia, Forenede Stater, 23321
        • Virginia Endo Res, LLC
      • Norfolk, Virginia, Forenede Stater, 23504
        • York Clinical Research LLC
      • Reston, Virginia, Forenede Stater, 20191-4327
        • CVS Store Number: 01396
      • Richmond, Virginia, Forenede Stater, 23230-3005
        • CVS Store Number: 1537
      • Winchester, Virginia, Forenede Stater, 22601
        • Amherst Family Practice P.C.
    • West Virginia
      • Morgantown, West Virginia, Forenede Stater, 26506
        • WVU Medicine
    • Wisconsin
      • Green Bay, Wisconsin, Forenede Stater, 54303
        • Prevea Health
  • Grækenland
      • Alexandroupoli, Grækenland, 68100
        • University Hospital of Alexandroupolis
      • Athens, Grækenland, 11527
        • "Laiko" General Hospital of Athens
      • Athens, Grækenland, 11528
        • Alexandra General Hospital, Therapeutic Clinic
      • Athens, Grækenland, GR-11528
        • Alexandra General Hospital, Therapeutic Clinic
      • Nikaia, Grækenland, GR-18454
        • Geniko Nosokomeio Nikaias Peiraia Ag. Panteleimon Geniko Nosokomeio Dytikis Attikis I - Diabetes Department
      • Piraeus, Grækenland, 18536
        • Geniko Nosokomeio Peiraia Tzaneio
      • Thessaloniki, Grækenland, GR-57001
        • "Thermi" Private Hosital
      • Thessaloniki, Grækenland, 54636
        • AHEPA General University Hospital
      • Thessaloniki, Grækenland, 57001
        • "Thermi" Private Hosital
      • Thessaloniki, Grækenland, 57010
        • General Hospital of Thessaloniki "G.Papanikolaou"
      • Thessaloniki, Grækenland, 54645
        • EUROMEDICA Gen Clinic The/ki, Endocrin,Metabolism,Diabetes
    • Attica
      • Athens, Attica, Grækenland, 12462
        • University Hospital of Athens ATTIKON
  • Italien
      • Bergamo, Italien, 24127
        • Azienda Ospedaliera Papa Giovanni XXIII
      • Catanzaro, Italien, 88100
        • Policlinico Mater Domini Università di Catanzaro
      • Montichiari, Italien, 25018
        • ASST degli Spedali Civili di Brescia-Presidio Ospedaliero di Montichiari
      • Naples, Italien, 80138
        • A.O.U. Università Studi della Campania "Luigi Vanvitelli"
      • Rome, Italien, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Dipartimento di scienze Mediche e Chirurgiche
    • Campania
      • Naples, Campania, Italien, 80138
        • A.O.U. Università Studi della Campania "Luigi Vanvitelli"
    • LT
      • Latina, LT, Italien, 04100
        • Ospedale Santa Maria Goretti - UOD Diabetologia
    • LU
      • Lucca, LU, Italien, 55100
        • Azienda Unita' Sanitaria Locale Toscana Nord Ovest - Cittadella della Salute Campo di Marte
    • MI
      • Milan, MI, Italien, 20132
        • Istituto Scientifico San Raffaele
    • RM
      • Roma, RM, Italien, 00161
        • Policlinico Umberto I Seconda Clinica Medica
    • Umbria
      • Perugia, Umbria, Italien, 06129
        • Azienda Ospedaliera di Perugia;Ospedale S. Maria della Misericordia
  • Portugal
      • Almada, Portugal, 2805-267
        • ULS De Almada-Seixal E.P.E. - Hospital Garcia de Orta
      • Aveiro, Portugal, 3814-501
        • ULS Da Regiao De Aveiro E.P.E. - Hospital Infante D. Pedro
      • Braga, Portugal, 4710-243
        • ULS De Braga, E.P.E. - Hospital de Braga
      • Caldas da Rainha, Portugal, 2500-176
        • ULS Do Oeste E.P.E. - Unidade Caldas da Rainha
      • Leiria, Portugal, 2410-197
        • ULS Da Região De Leiria E.P.E.- Hospital de Santo André
      • Lisbon, Portugal, 1349-019
        • Unidade Local De Saúde De Lisboa Ocidental E.P.E. - Hospital Egas Moniz
      • Lisbon, Portugal, 1050-099
        • Unidade Local De Saúde De São José, E.P.E. - Hospital Curry Cabral
      • Porto, Portugal, 4200-319
        • ULS De São João, E.P.E. - Hospital de São João
      • Porto, Portugal, 4099-001
        • ULS De Santo António, E.P.E. - Hospital de Santo António
      • Viana do Castelo, Portugal, 4904-858
        • ULS Do Alto Minho E.P.E. - Hospital de Santa Luzia
    • Matosinhos
      • Senhora Da Hora, Matosinhos, Matosinhos, Portugal, 4464-513
        • ULS De Matosinhos E.P.E.- Hospital Pedro Hispano
  • Puerto Rico
      • San Juan, Puerto Rico, 00918
        • Caribbean Medical Research Center
  • Rumænien
      • Brasov, Rumænien, 500283
        • Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed
      • Brasov, Rumænien, 500101
        • Mariodiab Clinic SRL
      • Brăila, Rumænien, 810197
        • Clinica Grivitei 224 S.R.L.
      • Bucharest, Rumænien, 040172
        • Diabs&Nutricare Srl
      • Constanța, Rumænien, 900591
        • Clinic of Diabetes Constanta
      • Galati, Rumænien, 800578
        • Clinical Emergency Sf. Apostol Andrei Hospital
      • Iași, Rumænien, 700547
        • SC Consultmed SRL
      • Ploieşti, Rumænien, 100561
        • S.C. Dianutrilife Medica S.R.L.
      • Satu Mare, Rumænien, 440055
        • Clinica Korall S.R.L. Satu Mare
      • Târgu Mureş, Rumænien, 540098
        • Dentosim Queen Srl
    • Bihor County
      • Oradea, Bihor County, Rumænien, 410159
        • Grandmed SRL
      • Oradea, Bihor County, Rumænien, 410001
        • Medical Practice SRL
    • Dâmbovița County
      • Targoviste, Dâmbovița County, Rumænien, 130083
        • Spitalul Judetean de Urgenta Targoviste
    • Maramureş
      • Baia Mare, Maramureş, Rumænien, 430222
        • CMI Dr Pop Lavinia
    • Prahova
      • Ploieşti, Prahova, Rumænien, 100018
        • Novus Medical Clinica SRL
    • Timiș County
      • Timișoara, Timiș County, Rumænien, 300125
        • Centrul Medical Sfantul Stefan
  • Rusland
      • Arkhangelsk, Rusland, 163001
        • Volosevich First City Clinical Hospital
      • Saint Petersburg, Rusland, 194356
        • Medinet LLC
      • Saint Petersburg, Rusland, 194358
        • SPb SBHI City polyclinic #117
      • Saint Petersburg, Rusland, 196084
        • Medical Research Institute LLC
      • Saint Petersburg, Rusland, 191014
        • SPb SBHI "Snegirev Maternity Hospital No. 6"
      • Yaroslavl, Rusland, 150003
        • Solovyev Clinical Emergency Hospital
      • Yaroslavl, Rusland, 150003
        • Solovyov Clinical Emergency Hospital
  • Slovakiet
      • Bojnice, Slovakiet, 97201
        • DIA - CLARUS s.r.o.
      • Bratislava, Slovakiet, 851 01
        • MEDISPEKTRUM s.r.o.
      • Bratislava, Slovakiet, 83103
        • MediTask, s.r.o
      • Levice, Slovakiet, 93401
        • DIA-MAX s.r.o.
      • Lučenec, Slovakiet, 984 01
        • IN-DIA s.r.o.
      • Martin, Slovakiet, 036 01
        • DIA - SANTMART, s.r.o., Ambulancia diabetologie a poruch latkovej premeny a vyzivy
      • Nové Zámky, Slovakiet, 940 59
        • FUNKYSTUFF s.r.o
      • Poprad, Slovakiet, 05801
        • Diakom, spol. s r.o.
      • Prešov, Slovakiet, 080 01
        • DIALIPID, s.r.o.
      • Rožňava, Slovakiet, 04801
        • Tatratrial s.r.o.
      • Sereď, Slovakiet, 926 01
        • Amb. Diabetologie a prouch latkovej premeny a vyzivy ENDIANT s.r.o.
      • Trenčín, Slovakiet, 911 01
        • MUDr. Korecova, metabolicke centrum s.r.o.
      • Štúrovo, Slovakiet, 943 01
        • BENROD s.r.o.
  • Spanien
      • Almería, Spanien, 04009
        • Centro Periférico de Especialidades Bola Azul
      • La Roca Del Vallés, Spanien, 08430
        • ABS La Roca del Vallés
      • La Roca Del Vallés, Spanien, 08430
        • ABS La Roca del Vallés_Endocrinología
      • Madrid, Spanien, 28031
        • Hospital Infanta Leonor
      • Palma de Mallorca, Spanien, 07120
        • Hospital Son Espases
      • Seville, Spanien, 41010
        • H. Infanta Luisa_Endocrino y Obesidad
  • Sydafrika
    • Gauteng
      • Benoni, Gauteng, Sydafrika, 1501
        • Diabetes Care Centre & CDE Centre
      • Benoni, Gauteng, Sydafrika, 1501
        • East Rand Physicians
      • Johannesburg, Gauteng, Sydafrika, 2198
        • Centre for Diabetes
      • Johannesburg, Gauteng, Sydafrika, 1501
        • East Rand Physicians
    • KwaZulu-Natal
      • Durban, KwaZulu-Natal, Sydafrika, 4450
        • Dr Pillay's Rooms
      • Durban, KwaZulu-Natal, Sydafrika, 4450
        • Dr J Reddy
      • eMkhomazi, KwaZulu-Natal, Sydafrika, 4170
        • Dr T Padayachee
  • Tjekkiet
      • Náchod, Tjekkiet, 547 01
        • EDUMED s.r.o.
      • Pardubice, Tjekkiet, 530 02
        • Diahelp - diabetologie
      • Plzen - Vychodni Predmesti, Tjekkiet, 326 00
        • MUDr. Jitka Zemanova - diabetologie a interna, s.r.o.
      • Prague, Tjekkiet, 110 00
        • Diabet2 s.r.o.
      • Prague, Tjekkiet, 140 00
        • MUDr. Michala Pelikanova
      • Prague, Tjekkiet, 18100
        • ResTrial s.r.o.
  • Ukraine
      • Kharkiv, Ukraine, 61058
        • Kharkiv Regional Clinical Hospital - Endocrinology department
      • Khmelnytskyi, Ukraine, 29000
        • Khmelnytskyi Regional Hospital - Endocrinology department
      • Ternopil, Ukraine, 46001
        • Ternopil Central District Hospital - Outpatient department
      • Zaporizhzhia, Ukraine, 69037
        • Medical centre"Elitmedservis"LLC

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  • Diagnosticeret med Type 2 Diabetes Mellitus (T2D) mellitus større end eller lig med (>=) 180 dage før screening.
  • Glyceret hæmoglobin (HbA1c) på 7-9 procent [(53-75 millimol pr. mol (mmol/mol)] (begge inklusive) som vurderet af centralt laboratorium på screeningsdagen.
  • Body mass index (BMI) større end eller lig med (>=) 25 kilogram pr. kvadratmeter (kg/m^2) på screeningsdagen.
  • Stabil daglig dosis større end eller lig med (>=) 90 dage før screening af nogen af ​​følgende antidiabetiske lægemidler eller kombinationsregimer:
  • Enhver metforminformulering større end eller lig med (>=) 1500 milligram (mg) eller maksimal tolereret eller effektiv dosis.
  • Enhver metforminkombinationsformulering større end eller lig med (>=) 1500 mg eller maksimal tolereret eller effektiv dosis.

Behandlingen kan være med eller uden natriumglucose cotransporter 2 (SGLT-2) hæmmere.

• Behandlet med insulin glargin én gang dagligt Enhed 100 injektioner mindre end eller lig med (<=) 40 enheder/dag større end eller lig med (>=) 90 dage før screening. Kortvarig bolusinsulinbehandling i højst 14 dage før screening er tilladt.

Ekskluderingskriterier:

  • Ukontrolleret og potentielt ustabil diabetisk retinopati eller makulopati. Verificeret ved fundusundersøgelse udført inden for de seneste 90 dage før screening eller i perioden mellem screening og randomisering. Farmakologisk pupiludvidelse er et krav, medmindre der anvendes et digitalt fundusfotograferingskamera, der er specificeret til ikke-dilateret undersøgelse.
  • Potentielt overset diagnose af type 1-diabetes (T1D) eller latent autoimmun diabetes hos voksne (LADA) verificeret med C-peptid mindre end 0,5 nanomol pr. liter (nmol/L) [1,5 nanogram pr. milliliter (ng/mL)] eller antistoffer mod glutaminsyre syredecarboxylase (anti-GAD) større end 5 enheder/milliliter, målt af centrallaboratoriet ved screening.
  • Tilstedeværelse eller historie af pancreatitis (akut eller kronisk).
  • Nedsat nyrefunktion målt som estimeret glomerulær filtrationshastighed (eGFR) værdi på mindre end 30 milliliter pr. minut pr. 1,73 kvadratmeter ved screening som defineret af Kidney Disease: Improving Global Outcomes (KDIGO) 2012 klassifikation.
  • Eventuelle episoder af diabetisk ketoacidose inden for 90 dage før screening.
  • Kendt hypoglykæmisk ubevidsthed som angivet af investigator i henhold til Clarkes spørgeskema spørgsmål 8.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Insulin glargin U100 (reduceret) + semaglutid
Deltagerne vil indledningsvis modtage 0,25 milligram (mg) en gang ugentlig semaglutid subkutant (s.c.), og dosis vil gradvist blive eskaleret til 2 mg som et supplement til dosisreduceret insulin glargin s.c. gives én gang dagligt. Insulin glargin U100 vil blive reduceret med 10 E ved initiering af semaglutid og derefter igen ved hver semaglutid dosiseskalering. Insulin glargin-dosis vil blive justeret baseret på gennemsnittet af tre selvmålte plasmaglucoseværdier (SMPG) før morgenmad (mål-SMPG: 4,4-7,2) millimol pr. liter (mmol/L)).
Medicin: Semaglutid
Deltagerne vil modtage semaglutid s.c. en gang om ugen. i 40 uger. Semaglutid 0,25 mg vil blive givet i uge 0, og derefter vil dosis blive eskaleret i uge 4, 8 og 12 til henholdsvis 0,5 mg, 1 mg, 2 mg.
Medicin: Insulin glargin U100 (reduceret)
Deltagerne vil modtage insulin glargin U100 s.c. en gang dagligt. Insulin glargin-dosis vil blive reduceret med 10 U ved påbegyndelse af semaglutid og derefter igen ved hver semaglutid dosiseskalering op til 40 uger. Dosis vil blive justeret baseret på gennemsnittet af tre SMPG-værdier før morgenmad (mål SMPG: 4,4-7,2 mmol/L).
Aktiv komparator: Insulin glargin U100 (titreret)
Deltagerne vil modtage titreret insulin glargin U100 s.c. en gang dagligt. Insulin glargin U100 dosis vil blive justeret baseret på gennemsnittet af tre SMPG værdier før morgenmad (mål SMPG: 4,4-7,2 mmol/L).
Medicin: Insulin glargin U100 (titreret)
Deltagerne vil modtage titreret insulin glargin U100 s.c. en gang dagligt i op til 40 uger. Dosis vil blive justeret baseret på gennemsnittet af tre SMPG-værdier før morgenmad (mål SMPG: 4,4-7,2 mmol/L).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Glycated Haemoglobin (HbA1c) [Noninferiority]
Tidsramme: From baseline (week 0) to end of treatment (week 40)
Change in HbA1c (Noninferiority) from baseline (Week 0) to end of treatment (Week 40) were reported. Here noninferiority was assessed based on the clinically acceptable margin of 0.3%-point for the mean treatment difference in HbA1c.
From baseline (week 0) to end of treatment (week 40)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Body Weight
Tidsramme: From baseline (week 0) to end of treatment (week 40)
Change in body weight from baseline (Week 0) to end of treatment (Week 40) were reported. Body weight was measured in unit 'Kilogram (kg)'.
From baseline (week 0) to end of treatment (week 40)
Percentage Change in Daily Insulin Dose
Tidsramme: From baseline (week 0) to end of treatment (week 40)
Percentage change in daily insulin dose from baseline (Week 0) to end of treatment (Week 40) were reported. Percentage change from baseline to week 40 in insulin dose (%) was calculated as: ([insulin dose at week 40] - [insulin dose at baseline]) / [insulin dose at baseline] × 100.
From baseline (week 0) to end of treatment (week 40)
Change in Glycated Haemoglobin (HbA1c ) [Superiority]
Tidsramme: From baseline (week 0) to end of treatment (week 40)
Change in HbA1c (Superiority) from baseline (Week 0) to end of treatment (Week 40) were reported.
From baseline (week 0) to end of treatment (week 40)
Score of Diabetes Treatment Satisfaction Questionnaire - Change Version (DTSQc)
Tidsramme: At end of treatment (week 40)
Score of Diabetes Treatment Satisfaction Questionnaire - change version (DTSQc) at end of treatment (week 40) were reported. The DTSQc provided a measure of how satisfied participants were with their current diabetes treatment compared with previous treatment. It consisted of 8 questions, which were to be answered on a Likert scale from -3 to +3 (-3 = much less satisfied now to +3 = much more satisfied now), with 0 (midpoint) representing no change. Out of 8 questions, 6 questions related to treatment satisfaction were summed to produce a total score. The DTSQc total treatment satisfaction score ranged from -18 to +18, with higher scores associated with greater treatment satisfaction.
At end of treatment (week 40)
Number of Participants Achieving Insulin Dose = 0 Units/mL (U)
Tidsramme: At end of treatment (week 40)
Number of participants achieving Insulin dose = 0 U at the end of treatment (Week 40) were reported.
At end of treatment (week 40)
Number of Participants Achieving Insulin Dose Reduced From Baseline by at Least 50%
Tidsramme: At end of treatment (week 40)
Number of participants achieving Insulin dose reduced from baseline by at least 50% by end pf treatment (Week 40) were reported.
At end of treatment (week 40)
Number of Participants Achieving HbA1c Less Than (<) 7%
Tidsramme: At end of treatment (week 40)
Number of participants achieving HbA1c < 7% at the end of treatment (Week 40) were reported.
At end of treatment (week 40)
Number of Severe Hypoglycaemic Episodes (Level 3)
Tidsramme: From baseline (week 0) to end of treatment (week 40)
Number of severe hypoglycaemic episodes (level 3) from baseline (week 0) to end of treatment (week 40) were reported. Severe hypoglycaemia (level 3) was defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery.
From baseline (week 0) to end of treatment (week 40)
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by Blood Glucose (BG) Meter)
Tidsramme: From baseline (week 0) to end of treatment (week 40)
Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter) from baseline (week 0) to end of treatment (week 40) were reported. Clinically significant hypoglycaemia (level 2) was defined as plasma glucose value of less than (<) 3.0 mmol/L (54 mg/dL) confirmed by BG meter.
From baseline (week 0) to end of treatment (week 40)
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by BG Meter) or Severe Hypoglycaemic Episodes (Level 3)
Tidsramme: From baseline (week 0) to end of treatment (week 40)
Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3) from baseline (week 0) to end of treatment (week 40) were reported. Clinically significant hypoglycaemia (level 2) was defined as plasma glucose value of less than (<) 3.0 mmol/L (54 mg/dL) confirmed by BG meter. Severe hypoglycaemia (level 3) was defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery.
From baseline (week 0) to end of treatment (week 40)
Number of Participants Achieving HbA1c Reduced From Baseline by at Least 0.3%-Points and Insulin Dose Reduced From Baseline, No Hypoglycaemic Episodes (< 3.9 mmol/L (70 mg/dL) Confirmed by BG Meter) and No Weight Gain
Tidsramme: At end of treatment (week 40)
Number of Participants achieving HbA1c reduced from baseline by at least 0.3%-points and Insulin dose reduced from baseline, No hypoglycaemic episodes (< 3.9 mmol/L (70 mg/dL) confirmed by BG meter) and No weight gain at the end of treatment (Week 40) were reported.
At end of treatment (week 40)
Change in Score of Diabetes Treatment Satisfaction Questionnaire - Status Version (DTSQs)
Tidsramme: From baseline (week 0) to end of treatment (week 40)
Score of Diabetes Treatment Satisfaction Questionnaire - status version (DTSQs) at end of treatment (week 40) were reported. The status version measures a patient's current satisfaction with treatment using a 0-6 scale for each item; higher scores indicate greater satisfaction with the present treatment (absolute/status level). The DTSQs total treatment satisfaction score ranged from 0 to 36, with higher scores associated with greater treatment satisfaction.
From baseline (week 0) to end of treatment (week 40)
Change in Score of Short Form 36 Version 2 (SF-36 v2)
Tidsramme: From baseline (week 0) to end of treatment (week 40)
Change in SF-36 physical and mental component from baseline (week 0) to end of treatment (Week 40) were presented. SF-36 is self-administered questionnaire that measures each of following 8 health domains: physical functioning, role limitations due to physical problems (role-physical), social functioning, bodily pain, mental health, role limitations due to emotional problems (role-emotional), vitality, and general health perception. There are also 2 component scores derived from the 8 subscale scores: mental component summary and physical component summary. Physical component summary contains physical functioning, role-physical, bodily pain and general health and mental component summary contain vitality, social functioning, role-emotional and mental health. Each SF-36 domain and component summary score ranges from 0 to 100, higher scores reflect better participant health status. A positive change score indicates an improvement since baseline.
From baseline (week 0) to end of treatment (week 40)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Novo Nordisk A/S

Efterforskere

  • Studieleder: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

29. august 2022

Primær færdiggørelse (Faktiske)

5. marts 2025

Studieafslutning (Faktiske)

9. april 2025

Datoer for studieregistrering

Først indsendt

22. august 2022

Først indsendt, der opfyldte QC-kriterier

22. august 2022

Først opslået (Faktiske)

24. august 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NN9535-4801
  • U1111-1267-0312 (Anden identifikator: World Health Organization (WHO))
  • 2021-004392-13 (EudraCT nummer)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Ifølge Novo Nordisks oplysningsforpligtelse på novonordisk-trials.com

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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