En forskningsstudie for å se på hvordan Semaglutid, sammen med en lavere dose insulin Glargine, sammenlignes med en høyere dose insulin Glargine alene hos personer med type 2-diabetes (SUSTAIN OPTIMIZE)
17. april 2026 oppdatert av: Novo Nordisk A/S
Effekt og sikkerhet av Semaglutid S.C. 2,0 mg en gang i uken som tillegg til doseredusert insulin Glargine vs titrert Insulin Glargine hos deltakere med type 2 diabetes og overvekt
Denne studien sammenligner semaglutid, sammen med en lavere dose insulin glargin, med en høyere dose insulin glargin hos deltakere med type 2 diabetes.
Studien ser på hvor godt studiemedisinene kontrollerer blodsukkernivået.
Deltakerne vil enten få semaglutid sammen med en lavere dose insulin glargin eller en høyere dose insulin glargin.
Studien vil vare i ca. 47 uker (ca. 11 måneder).
Deltakerne vil ha 9 klinikkbesøk, 15 telefon/videosamtaler og 1 hjemmebesøk.
Deltakerne vil bli bedt om å bruke en sensor som måler blodsukkeret hele tiden i 2 perioder på 10 dager i løpet av studien.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
573
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Alabama
-
Sheffield, Alabama, Forente stater, 35660
- Shoals Primary Care
-
-
Arizona
-
Glendale, Arizona, Forente stater, 85308
- Lenzmeier Fam Med CCT Research
-
Mesa, Arizona, Forente stater, 85213
- Synexus Clinical Research US, Inc./Desert Clinical Research,
-
-
Arkansas
-
Searcy, Arkansas, Forente stater, 72143
- Unity Health-Searcy Medical Center
-
Searcy, Arkansas, Forente stater, 72143
- OneLife Direct Care Inc.
-
-
California
-
Canoga Park, California, Forente stater, 91304
- San Fernando Valley Hlth Inst, LLC
-
Chula Vista, California, Forente stater, 91911
- Velocity Clin Res-Chula Vista
-
Concord, California, Forente stater, 94520
- John Muir Physicians Network
-
Fresno, California, Forente stater, 93720
- Valley Research
-
Fullerton, California, Forente stater, 92835
- Providence Medical Foundation
-
Fullerton, California, Forente stater, 92835
- Ascada Research
-
Huntington Park, California, Forente stater, 90255
- Velocity Clinical Research Huntington Park
-
La Jolla, California, Forente stater, 92037
- Scripps Memorial Hospital La Jolla
-
La Mesa, California, Forente stater, 91942
- Velocity Clin Res San Diego
-
Lancaster, California, Forente stater, 93534
- First Valley Medical Group
-
Loma Linda, California, Forente stater, 92354
- Loma Linda Univ Hlth Cr Endo
-
Lomita, California, Forente stater, 90717
- Torrance Clin Res Inst, Inc.
-
Los Angeles, California, Forente stater, 90017
- Downtown LA Res Ctr. Inc.
-
Los Angeles, California, Forente stater, 90015
- NRC Research Institute
-
Los Angeles, California, Forente stater, 90017
- Velocity Clin Res Los Angeles
-
Northridge, California, Forente stater, 91325
- Valley Clinical Trials, Inc.
-
San Diego, California, Forente stater, 92120
- Wetlin Research Associates, Inc.
-
San Diego, California, Forente stater, 92111
- San Diego Family Care_San Diego
-
Tustin, California, Forente stater, 92780
- University Clin Investigators
-
-
Colorado
-
Denver, Colorado, Forente stater, 80209
- Velocity Clin Res, Denver
-
-
Connecticut
-
Waterbury, Connecticut, Forente stater, 06708
- Chase Medical Research LLC
-
-
Florida
-
Hialeah, Florida, Forente stater, 33012
- Indago Research & Health Center Inc.
-
Hollywood, Florida, Forente stater, 33024
- Encore Medical Research LLC
-
Jacksonville, Florida, Forente stater, 32216
- Jacksonville Ctr for Clin Res
-
Jacksonville, Florida, Forente stater, 32204
- Northeast Res Inst. Inc.
-
Jacksonville, Florida, Forente stater, 32277
- Care-Partners-Clinical-Research, LLC
-
Miami, Florida, Forente stater, 33165
- New Horizon Research Center
-
Miami, Florida, Forente stater, 33135
- Suncoast Research Group, LLC
-
Miami, Florida, Forente stater, 33175
- Reyes Clinical Research, Inc
-
Miami, Florida, Forente stater, 33183
- International Research Associates, LLC_Miami
-
Miami, Florida, Forente stater, 33169
- Elite Research Center
-
Miami, Florida, Forente stater, 33175
- Diverse Clinical Research Miami
-
Miramar, Florida, Forente stater, 33027
- South Broward Research LLC
-
New Port Richey, Florida, Forente stater, 34652
- Suncoast Clinical Research, Inc._New Port Richey
-
New Port Richey, Florida, Forente stater, 34652
- Suncoast Clin Res Port Richey
-
Ocala, Florida, Forente stater, 34470
- Renstar Medical Research
-
Tampa, Florida, Forente stater, 33607
- Clinical Research Trials of Florida
-
-
Georgia
-
Atlanta, Georgia, Forente stater, 30329-4015
- CVS Store Number: 7689
-
Canton, Georgia, Forente stater, 30114
- East Coast Institute for Res
-
Hinesville, Georgia, Forente stater, 31313
- Coastal Heritage Clinical Research
-
Macon, Georgia, Forente stater, 31210
- East Coast Institute for Res
-
Roswell, Georgia, Forente stater, 30076
- Endocrine Research Solutions
-
Savannah, Georgia, Forente stater, 31405-6901
- CVS Store Number: 05520
-
-
Idaho
-
Meridian, Idaho, Forente stater, 83646
- Solaris Clinical Research
-
-
Illinois
-
Chicago, Illinois, Forente stater, 60607
- Cedar-Crosse Research Center
-
Chicago, Illinois, Forente stater, 60661
- WellNow Urgent Care
-
-
Indiana
-
Indianapolis, Indiana, Forente stater, 46260
- Brengle Family Medicine
-
-
Iowa
-
Council Bluffs, Iowa, Forente stater, 51501
- West Broadway Clinic
-
West Des Moines, Iowa, Forente stater, 50265
- Iowa Diab & Endo Res Center
-
West Des Moines, Iowa, Forente stater, 50266
- Iowa Diab & Endo Res Center
-
-
Kansas
-
Topeka, Kansas, Forente stater, 66606
- Cotton O'Neil Diab & Endo Ctr
-
-
Kentucky
-
Lexington, Kentucky, Forente stater, 40503
- The Research Group of Lexington LLC
-
Louisville, Kentucky, Forente stater, 40213
- L-MARC Research Center
-
-
Louisiana
-
Monroe, Louisiana, Forente stater, 71203
- Arthritis and Diabetes Clinic, Inc.
-
New Orleans, Louisiana, Forente stater, 70119
- AMR New Orleans
-
Slidell, Louisiana, Forente stater, 70461
- Ileana J. Tandron, MD APMC (a private medical office)
-
-
Maryland
-
Hyattsville, Maryland, Forente stater, 20782
- MedStar Hlth Res Institute
-
Rockville, Maryland, Forente stater, 20852
- Endo And Metab Cons
-
-
Massachusetts
-
Boston, Massachusetts, Forente stater, 02215
- Joslin Diabetes Center
-
Boston, Massachusetts, Forente stater, 02115
- Brigham & Women's Hospital
-
-
Michigan
-
Buckley, Michigan, Forente stater, 49620
- Northern Pines Hlth Ctr, PC
-
Detroit, Michigan, Forente stater, 48202
- Henry Ford Health System
-
Flint, Michigan, Forente stater, 48532
- Elite Research Center
-
Troy, Michigan, Forente stater, 48098
- Arcturus HC PLC Troy Med Res
-
-
Missouri
-
City of Saint Peters, Missouri, Forente stater, 63303
- StudyMetrix Research LLC
-
-
Montana
-
Butte, Montana, Forente stater, 59701
- Mercury Str Med Grp, PLLC
-
-
Nebraska
-
Elkhorn, Nebraska, Forente stater, 68022
- Clinical Research Advantage, Inc./Skyline Medical Center, PC
-
Fremont, Nebraska, Forente stater, 68025
- Methodist Physicians Clinic
-
Norfolk, Nebraska, Forente stater, 68701
- Velocity Clin Res, Norfolk
-
Omaha, Nebraska, Forente stater, 68144
- Midwest Regional Health Services
-
Omaha, Nebraska, Forente stater, 68198-3020
- Univ of Nebraska Medical CTR
-
-
Nevada
-
Las Vegas, Nevada, Forente stater, 89128
- Palm Research Center Inc-Vegas
-
-
New Hampshire
-
Nashua, New Hampshire, Forente stater, 03060
- Southern New Hampshire Diabetes and Endocrinology
-
-
New Jersey
-
Trenton, New Jersey, Forente stater, 08611
- Premier Research Inc.
-
-
New York
-
Albany, New York, Forente stater, 12203
- AMC Community Endocrinology
-
Brooklyn, New York, Forente stater, 11229
- Dr. Alexander Perkelvald
-
New Windsor, New York, Forente stater, 12553
- Mid Hudson Med Res-New Windsor
-
Westfield, New York, Forente stater, 14787
- Great Lakes Medical Research
-
-
North Carolina
-
Chapel Hill, North Carolina, Forente stater, 27514
- University of North Carolina Medical Center
-
Greenville, North Carolina, Forente stater, 27834
- Physicians East Endocrinology
-
Morehead City, North Carolina, Forente stater, 28557
- Carteret Medical Group
-
Morehead City, North Carolina, Forente stater, 28557
- Centricity Rsrch MHCity Multi
-
-
North Dakota
-
Fargo, North Dakota, Forente stater, 58104
- Lillestol Research LLC
-
-
Ohio
-
Beachwood, Ohio, Forente stater, 44122
- Velocity Clin Res Cleveland
-
Canton, Ohio, Forente stater, 44718
- Diab & Endo Assoc of Stark Co
-
Cincinnati, Ohio, Forente stater, 45219
- Velocity Clin Res_Cincinnati
-
Mason, Ohio, Forente stater, 45040
- Albert J Weisbrot
-
Maumee, Ohio, Forente stater, 43537
- Advanced Med Res Maumee
-
Toledo, Ohio, Forente stater, 43614
- University of Toledo Medical Center
-
Toledo, Ohio, Forente stater, 43614
- University of Toledo_Toledo
-
-
Oklahoma
-
Norman, Oklahoma, Forente stater, 73069
- Lynn Institute of Norman
-
Norman, Oklahoma, Forente stater, 73069
- Intend Research
-
-
Oregon
-
Medford, Oregon, Forente stater, 97504
- Velocity Clinical Res Medford
-
-
Pennsylvania
-
Beaver, Pennsylvania, Forente stater, 15009
- Heritage Valley Multispeciality Group Inc
-
Johnstown, Pennsylvania, Forente stater, 15905
- Richard M Kastelic MD Assoc
-
Philadelphia, Pennsylvania, Forente stater, 19107
- Thomas Jefferson University
-
Uniontown, Pennsylvania, Forente stater, 15401
- Preferred Primary Care Physicians, Inc.
-
-
South Carolina
-
Myrtle Beach, South Carolina, Forente stater, 29572
- Carolina Health Specialists
-
Summerville, South Carolina, Forente stater, 29485
- Palmetto Clinical Research
-
-
Tennessee
-
Chattanooga, Tennessee, Forente stater, 37404
- Chattanooga Medical Research, LLC
-
Chattanooga, Tennessee, Forente stater, 37411
- Univ Diab & Endo Consultants
-
Jackson, Tennessee, Forente stater, 38305
- Jackson Clinic
-
Kingsport, Tennessee, Forente stater, 37660
- Holston Medical Group
-
Knoxville, Tennessee, Forente stater, 37938
- Accellacare US Inc., d/b/a Accellacare of Knoxville
-
Memphis, Tennessee, Forente stater, 38119
- Clinical Neuroscience Solutions
-
-
Texas
-
Amarillo, Texas, Forente stater, 79106
- Amarillo Med Spec LLP
-
Arlington, Texas, Forente stater, 76012-4637
- Arlington Family Res. Ctr Inc
-
Austin, Texas, Forente stater, 78705
- Central Texas Clinical Research
-
Cedar Park, Texas, Forente stater, 78613
- Velocity Clin Res Austin
-
Dallas, Texas, Forente stater, 75230
- Velocity Clinical Res-Dallas
-
Dallas, Texas, Forente stater, 75208
- Thyroid Endocrinology & Diabetes PA
-
El Paso, Texas, Forente stater, 79935
- Academy of Diabetes, T&E
-
Fort Worth, Texas, Forente stater, 76132
- Diabetes and Thyroid Ctr of FW
-
Houston, Texas, Forente stater, 77074
- Houston Institute for Clinical Research
-
Houston, Texas, Forente stater, 77040
- JCCT- Juno NW Houston
-
Houston, Texas, Forente stater, 77029
- Gonzalez Family & Occupational Medicine
-
Hurst, Texas, Forente stater, 76054
- Protenium Clinical Research
-
Longview, Texas, Forente stater, 75605
- DCOL Ctr for Clin Res
-
McKinney, Texas, Forente stater, 75069
- Tekton Research
-
Plano, Texas, Forente stater, 75075
- Clinical Investigations of Texas
-
San Antonio, Texas, Forente stater, 78230
- VIP Trials
-
San Antonio, Texas, Forente stater, 78224
- Briggs Clinical Research, LLC
-
San Antonio, Texas, Forente stater, 78220
- San Antonio Prem Int Med
-
San Antonio, Texas, Forente stater, 78229
- Diabetes Glandular Diseases Clinic
-
San Antonio, Texas, Forente stater, 78240
- Diabetes Glandular Diseases Clinic
-
Shavano Park, Texas, Forente stater, 78231
- Consano Clinical Research, LLC
-
Sugar Land, Texas, Forente stater, 77479
- Med-Olam Clinical Reseach LLC
-
Waco, Texas, Forente stater, 76708
- Hillcrest Family Health Center
-
-
Utah
-
Ogden, Utah, Forente stater, 84405
- Advanced Research Institute
-
Ogden, Utah, Forente stater, 84405
- South Ogden Family Medicine/ CCT Research
-
Salt Lake City, Utah, Forente stater, 84117
- Olympus Family Medicine
-
St. George, Utah, Forente stater, 84790
- Chrysalis Clinical Research
-
West Jordan, Utah, Forente stater, 84088
- Velocity Clin Res-Salt Lk City
-
-
Virginia
-
Chesapeake, Virginia, Forente stater, 23321
- Virginia Endo Res, LLC
-
Norfolk, Virginia, Forente stater, 23504
- York Clinical Research LLC
-
Reston, Virginia, Forente stater, 20191-4327
- CVS Store Number: 01396
-
Richmond, Virginia, Forente stater, 23230-3005
- CVS Store Number: 1537
-
Winchester, Virginia, Forente stater, 22601
- Amherst Family Practice P.C.
-
-
West Virginia
-
Morgantown, West Virginia, Forente stater, 26506
- WVU Medicine
-
-
Wisconsin
-
Green Bay, Wisconsin, Forente stater, 54303
- Prevea Health
-
-
-
-
-
Alexandroupoli, Hellas, 68100
- University Hospital of Alexandroupolis
-
Athens, Hellas, 11527
- "Laiko" General Hospital of Athens
-
Athens, Hellas, 11528
- Alexandra General Hospital, Therapeutic Clinic
-
Athens, Hellas, GR-11528
- Alexandra General Hospital, Therapeutic Clinic
-
Nikaia, Hellas, GR-18454
- Geniko Nosokomeio Nikaias Peiraia Ag. Panteleimon Geniko Nosokomeio Dytikis Attikis I - Diabetes Department
-
Piraeus, Hellas, 18536
- Geniko Nosokomeio Peiraia Tzaneio
-
Thessaloniki, Hellas, GR-57001
- "Thermi" Private Hosital
-
Thessaloniki, Hellas, 54636
- AHEPA General University Hospital
-
Thessaloniki, Hellas, 57001
- "Thermi" Private Hosital
-
Thessaloniki, Hellas, 57010
- General Hospital of Thessaloniki "G.Papanikolaou"
-
Thessaloniki, Hellas, 54645
- EUROMEDICA Gen Clinic The/ki, Endocrin,Metabolism,Diabetes
-
-
Attica
-
Athens, Attica, Hellas, 12462
- University Hospital of Athens ATTIKON
-
-
-
-
-
Bergamo, Italia, 24127
- Azienda Ospedaliera Papa Giovanni XXIII
-
Catanzaro, Italia, 88100
- Policlinico Mater Domini Università di Catanzaro
-
Montichiari, Italia, 25018
- ASST degli Spedali Civili di Brescia-Presidio Ospedaliero di Montichiari
-
Naples, Italia, 80138
- A.O.U. Università Studi della Campania "Luigi Vanvitelli"
-
Rome, Italia, 00168
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Dipartimento di scienze Mediche e Chirurgiche
-
-
Campania
-
Naples, Campania, Italia, 80138
- A.O.U. Università Studi della Campania "Luigi Vanvitelli"
-
-
LT
-
Latina, LT, Italia, 04100
- Ospedale Santa Maria Goretti - UOD Diabetologia
-
-
LU
-
Lucca, LU, Italia, 55100
- Azienda Unita' Sanitaria Locale Toscana Nord Ovest - Cittadella della Salute Campo di Marte
-
-
MI
-
Milan, MI, Italia, 20132
- Istituto Scientifico San Raffaele
-
-
RM
-
Roma, RM, Italia, 00161
- Policlinico Umberto I Seconda Clinica Medica
-
-
Umbria
-
Perugia, Umbria, Italia, 06129
- Azienda Ospedaliera di Perugia;Ospedale S. Maria della Misericordia
-
-
-
-
-
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
-
-
-
-
-
San Juan, Puerto Rico, 00918
- Caribbean Medical Research Center
-
-
-
-
-
Brasov, Romania, 500283
- Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed
-
Brasov, Romania, 500101
- Mariodiab Clinic SRL
-
Brăila, Romania, 810197
- Clinica Grivitei 224 S.R.L.
-
Bucharest, Romania, 040172
- Diabs&Nutricare Srl
-
Constanța, Romania, 900591
- Clinic of Diabetes Constanta
-
Galati, Romania, 800578
- Clinical Emergency Sf. Apostol Andrei Hospital
-
Iași, Romania, 700547
- SC Consultmed SRL
-
Ploieşti, Romania, 100561
- S.C. Dianutrilife Medica S.R.L.
-
Satu Mare, Romania, 440055
- Clinica Korall S.R.L. Satu Mare
-
Târgu Mureş, Romania, 540098
- Dentosim Queen Srl
-
-
Bihor County
-
Oradea, Bihor County, Romania, 410159
- Grandmed SRL
-
Oradea, Bihor County, Romania, 410001
- Medical Practice SRL
-
-
Dâmbovița County
-
Targoviste, Dâmbovița County, Romania, 130083
- Spitalul Judetean de Urgenta Targoviste
-
-
Maramureş
-
Baia Mare, Maramureş, Romania, 430222
- CMI Dr Pop Lavinia
-
-
Prahova
-
Ploieşti, Prahova, Romania, 100018
- Novus Medical Clinica SRL
-
-
Timiș County
-
Timișoara, Timiș County, Romania, 300125
- Centrul Medical Sfantul Stefan
-
-
-
-
-
Arkhangelsk, Russland, 163001
- Volosevich First City Clinical Hospital
-
Saint Petersburg, Russland, 194356
- Medinet LLC
-
Saint Petersburg, Russland, 194358
- SPb SBHI City polyclinic #117
-
Saint Petersburg, Russland, 196084
- Medical Research Institute LLC
-
Saint Petersburg, Russland, 191014
- SPb SBHI "Snegirev Maternity Hospital No. 6"
-
Yaroslavl, Russland, 150003
- Solovyev Clinical Emergency Hospital
-
Yaroslavl, Russland, 150003
- Solovyov Clinical Emergency Hospital
-
-
-
-
-
Bojnice, Slovakia, 97201
- DIA - CLARUS s.r.o.
-
Bratislava, Slovakia, 851 01
- MEDISPEKTRUM s.r.o.
-
Bratislava, Slovakia, 83103
- MediTask, s.r.o
-
Levice, Slovakia, 93401
- DIA-MAX s.r.o.
-
Lučenec, Slovakia, 984 01
- IN-DIA s.r.o.
-
Martin, Slovakia, 036 01
- DIA - SANTMART, s.r.o., Ambulancia diabetologie a poruch latkovej premeny a vyzivy
-
Nové Zámky, Slovakia, 940 59
- FUNKYSTUFF s.r.o
-
Poprad, Slovakia, 05801
- Diakom, spol. s r.o.
-
Prešov, Slovakia, 080 01
- DIALIPID, s.r.o.
-
Rožňava, Slovakia, 04801
- Tatratrial s.r.o.
-
Sereď, Slovakia, 926 01
- Amb. Diabetologie a prouch latkovej premeny a vyzivy ENDIANT s.r.o.
-
Trenčín, Slovakia, 911 01
- MUDr. Korecova, metabolicke centrum s.r.o.
-
Štúrovo, Slovakia, 943 01
- BENROD s.r.o.
-
-
-
-
-
Almería, Spania, 04009
- Centro Periferico De Especialidades Bola Azul
-
La Roca Del Vallés, Spania, 08430
- ABS La Roca del Vallés
-
La Roca Del Vallés, Spania, 08430
- ABS La Roca del Vallés_Endocrinología
-
Madrid, Spania, 28031
- Hospital Infanta Leonor
-
Palma de Mallorca, Spania, 07120
- Hospital Son Espases
-
Seville, Spania, 41010
- H. Infanta Luisa_Endocrino y Obesidad
-
-
-
-
Gauteng
-
Benoni, Gauteng, Sør-Afrika, 1501
- Diabetes Care Centre & CDE Centre
-
Benoni, Gauteng, Sør-Afrika, 1501
- East Rand Physicians
-
Johannesburg, Gauteng, Sør-Afrika, 2198
- Centre for Diabetes
-
Johannesburg, Gauteng, Sør-Afrika, 1501
- East Rand Physicians
-
-
KwaZulu-Natal
-
Durban, KwaZulu-Natal, Sør-Afrika, 4450
- Dr Pillay's Rooms
-
Durban, KwaZulu-Natal, Sør-Afrika, 4450
- Dr J Reddy
-
eMkhomazi, KwaZulu-Natal, Sør-Afrika, 4170
- Dr T Padayachee
-
-
-
-
-
Náchod, Tsjekkia, 547 01
- Edumed s.r.o.
-
Pardubice, Tsjekkia, 530 02
- Diahelp - diabetologie
-
Plzen - Vychodni Predmesti, Tsjekkia, 326 00
- MUDr. Jitka Zemanova - diabetologie a interna, s.r.o.
-
Prague, Tsjekkia, 110 00
- Diabet2 s.r.o.
-
Prague, Tsjekkia, 140 00
- MUDr. Michala Pelikanova
-
Prague, Tsjekkia, 18100
- ResTrial s.r.o.
-
-
-
-
-
Kharkiv, Ukraina, 61058
- Kharkiv Regional Clinical Hospital - Endocrinology department
-
Khmelnytskyi, Ukraina, 29000
- Khmelnytskyi Regional Hospital - Endocrinology department
-
Ternopil, Ukraina, 46001
- Ternopil Central District Hospital - Outpatient department
-
Zaporizhzhia, Ukraina, 69037
- Medical centre"Elitmedservis"LLC
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Beskrivelse
Inklusjonskriterier:
- Diagnostisert med type 2 diabetes mellitus (T2D) mellitus større enn eller lik (>=) 180 dager før screening.
- Glykert hemoglobin (HbA1c) på 7-9 prosent [(53-75 millimol per mol (mmol/mol)] (begge inkludert) som vurdert av sentrallaboratoriet på screeningsdagen.
- Kroppsmasseindeks (BMI) større enn eller lik (>=) 25 kilo per kvadratmeter (kg/m^2) på screeningsdagen.
- Stabil daglig dose større enn eller lik (>=) 90 dager før screening av noen av følgende antidiabetiske legemidler eller kombinasjonsregimer:
- Alle metforminformuleringer større enn eller lik (>=) 1500 milligram (mg) eller maksimal tolerert eller effektiv dose.
- Enhver metforminkombinasjonsformulering større enn eller lik (>=) 1500 mg eller maksimal tolerert eller effektiv dose.
Behandlingen kan være med eller uten natriumglukose cotransporter 2 (SGLT-2) hemmere.
• Behandlet med insulin glargin én gang daglig Enhet 100 injeksjoner mindre enn eller lik (<=) 40 enheter/dag større enn eller lik (>=) 90 dager før screening. Kortvarig bolusinsulinbehandling i maksimalt 14 dager før screening tillates.
Ekskluderingskriterier:
- Ukontrollert og potensielt ustabil diabetisk retinopati eller makulopati. Verifisert ved fundusundersøkelse utført innen de siste 90 dagene før screening eller i perioden mellom screening og randomisering. Farmakologisk pupillutvidelse er et krav med mindre bruk av et digitalt fundusfotokamera spesifisert for ikke-dilatert undersøkelse.
- Potensielt ubesvarte diagnose av type 1 diabetes (T1D) eller latent autoimmun diabetes hos voksne (LADA) bekreftet av C-peptid mindre enn 0,5 nanomol per liter (nmol/L) [1,5 nanogram per milliliter (ng/ml)] eller antistoffer mot glutaminsyre sur dekarboksylase (anti-GAD) større enn 5 enheter/milliliter, målt av sentrallaboratoriet ved screening.
- Tilstedeværelse eller historie med pankreatitt (akutt eller kronisk).
- Nedsatt nyrefunksjon målt som estimert Glomerular Filtration Rate (eGFR) verdi på mindre enn 30 milliliter per minutt per 1,73 kvadratmeter ved screening som definert av Kidney Disease: Improving Global Outcomes (KDIGO) 2012 klassifisering.
- Eventuelle episoder med diabetisk ketoacidose innen 90 dager før screening.
- Kjent hypoglykemisk uvitenhet som indikert av etterforskeren i henhold til Clarkes spørreskjema spørsmål 8.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Insulin glargin U100 (redusert) + semaglutid
Deltakerne vil i utgangspunktet motta 0,25 milligram (mg) en gang ukentlig semaglutid subkutant (s.c.), og dosen vil gradvis økes til 2 mg som tillegg til doseredusert insulin glargin s.c.
gitt en gang daglig.
Insulin glargin U100 vil reduseres med 10 U ved initiering av semaglutid og deretter igjen ved hver doseeskalering av semaglutid.
Insulin glargin-dosen vil bli justert basert på gjennomsnittet av tre selvmålte plasmaglukoseverdier (SMPG) før frokost (mål-SMPG: 4,4-7,2)
millimol per liter (mmol/L)).
|
Deltakerne vil motta en gang ukentlig semaglutid s.c. i 40 uker.
Semaglutid 0,25 mg gis ved uke 0 og deretter økes dosen ved henholdsvis uke 4, 8 og 12 til 0,5 mg, 1 mg, 2 mg.
Deltakerne vil få insulin glargin U100 s.c.
en gang om dagen.
Insulin glargin-dosen vil reduseres med 10 U ved initiering av semaglutid og deretter igjen ved hver semaglutiddoseeskalering opp til 40 uker.
Dosen vil bli justert basert på gjennomsnittet av tre SMPG-verdier før frokost (mål SMPG: 4,4-7,2
mmol/L).
|
|
Aktiv komparator: Insulin glargin U100 (titrert)
Deltakerne vil motta titrert insulin glargin U100 s.c.
en gang om dagen.
Insulin glargin U100-dosen vil bli justert basert på gjennomsnittet av tre SMPG-verdier før frokost (mål SMPG: 4,4-7,2
mmol/L).
|
Deltakerne vil motta titrert insulin glargin U100 s.c.
en gang daglig i opptil 40 uker.
Dosen vil bli justert basert på gjennomsnittet av tre SMPG-verdier før frokost (mål SMPG: 4,4-7,2
mmol/L).
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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)
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Clinical Transparency (dept. 2834), Novo Nordisk A/S
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
29. august 2022
Primær fullføring (Faktiske)
5. mars 2025
Studiet fullført (Faktiske)
9. april 2025
Datoer for studieregistrering
Først innsendt
22. august 2022
Først innsendt som oppfylte QC-kriteriene
22. august 2022
Først lagt ut (Faktiske)
24. august 2022
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
11. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
17. april 2026
Sist bekreftet
1. april 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Sykdommer i det endokrine systemet
- Ernæringsforstyrrelser
- Metabolske sykdommer
- Overernæring
- Kroppsvekt
- Glukosemetabolismeforstyrrelser
- Sukkersyke
- Overvektig
- Patologiske tilstander, tegn og symptomer
- Ernæringsmessige og metabolske sykdommer
- Tegn og symptomer
- Overvekt
- Diabetes mellitus, type 2
- Glukagon-lignende peptid-1-reseptoragonister
- Fysiologiske effekter av legemidler
- Hypoglykemiske midler
- semaglutid
Andre studie-ID-numre
- NN9535-4801
- U1111-1267-0312 (Annen identifikator: World Health Organization (WHO))
- 2021-004392-13 (EudraCT-nummer)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
I følge Novo Nordisks avsløringsforpliktelse på novonordisk-trials.com
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .