A Research Study to Look Into How Semaglutide, Together With a Lower Dose of Insulin Glargine, Compares to a Higher Dose of Insulin Glargine Alone in People With Type 2 Diabetes (SUSTAIN OPTIMIZE)

Efficacy and Safety of Once-weekly Semaglutide S.C. 2.0 mg as Add-on to Dose-reduced Insulin Glargine vs Titrated Insulin Glargine in Participants With Type 2 Diabetes and Overweight

This study compares semaglutide, together with a lower dose of insulin glargine, to a higher dose of insulin glargine in participants with type 2 diabetes. The study looks at how well the study medicines control blood glucose levels. Participants will either get semaglutide together with a lower dose of insulin glargine or a higher dose of insulin glargine. The study will last for about 47 weeks (approximately 11 months). Participants will have 9 clinic visits, 15 phone/video calls and 1 home visit. Participants will be asked to wear a sensor that measures their blood sugar all the time in 2 periods of 10 days during the study.

Study Overview

• Status: Completed
• Conditions: Obesity; Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Semaglutide; Drug: Insuline glargine U100 (reduced); Drug: Insuline glargine U100 (titrated)

• Study Type: Interventional
• Enrollment (Actual): 573
• Phase: Phase 3

Contacts and Locations

Study Locations

• Czechia
  • Náchod, Czechia, 547 01
    • EDUMED s.r.o.
  • Pardubice, Czechia, 530 02
    • Diahelp - diabetologie
  • Plzen - Vychodni Predmesti, Czechia, 326 00
    • MUDr. Jitka Zemanova - diabetologie a interna, s.r.o.
  • Prague, Czechia, 110 00
    • Diabet2 s.r.o.
  • Prague, Czechia, 140 00
    • MUDr. Michala Pelikanova
  • Prague, Czechia, 18100
    • ResTrial s.r.o.
• Greece
  • Alexandroupoli, Greece, 68100
    • University Hospital of Alexandroupolis
  • Athens, Greece, 11527
    • "Laiko" General Hospital of Athens
  • Athens, Greece, 11528
    • Alexandra General Hospital, Therapeutic Clinic
  • Athens, Greece, GR-11528
    • Alexandra General Hospital, Therapeutic Clinic
  • Nikaia, Greece, GR-18454
    • Geniko Nosokomeio Nikaias Peiraia Ag. Panteleimon Geniko Nosokomeio Dytikis Attikis I - Diabetes Department
  • Piraeus, Greece, 18536
    • Geniko Nosokomeio Peiraia Tzaneio
  • Thessaloniki, Greece, GR-57001
    • "Thermi" Private Hosital
  • Thessaloniki, Greece, 54636
    • AHEPA General University Hospital
  • Thessaloniki, Greece, 57001
    • "Thermi" Private Hosital
  • Thessaloniki, Greece, 57010
    • General Hospital of Thessaloniki "G.Papanikolaou"
  • Thessaloniki, Greece, 54645
    • EUROMEDICA Gen Clinic The/ki, Endocrin,Metabolism,Diabetes
  • Attica
    • Athens, Attica, Greece, 12462
      • University Hospital of Athens ATTIKON
• Italy
  • Bergamo, Italy, 24127
    • Azienda Ospedaliera Papa Giovanni XXIII
  • Catanzaro, Italy, 88100
    • Policlinico Mater Domini Università di Catanzaro
  • Montichiari, Italy, 25018
    • ASST degli Spedali Civili di Brescia-Presidio Ospedaliero di Montichiari
  • Naples, Italy, 80138
    • A.O.U. Università Studi della Campania "Luigi Vanvitelli"
  • Rome, Italy, 00168
    • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Dipartimento di scienze Mediche e Chirurgiche
  • Campania
    • Naples, Campania, Italy, 80138
      • A.O.U. Università Studi della Campania "Luigi Vanvitelli"
  • LT
    • Latina, LT, Italy, 04100
      • Ospedale Santa Maria Goretti - UOD Diabetologia
  • LU
    • Lucca, LU, Italy, 55100
      • Azienda Unita' Sanitaria Locale Toscana Nord Ovest - Cittadella della Salute Campo di Marte
  • MI
    • Milan, MI, Italy, 20132
      • Istituto Scientifico San Raffaele
  • RM
    • Roma, RM, Italy, 00161
      • Policlinico Umberto I Seconda Clinica Medica
  • Umbria
    • Perugia, Umbria, Italy, 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
• Romania
  • 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
• Russia
  • Arkhangelsk, Russia, 163001
    • Volosevich First City Clinical Hospital
  • Saint Petersburg, Russia, 194356
    • Medinet LLC
  • Saint Petersburg, Russia, 194358
    • SPb SBHI City polyclinic #117
  • Saint Petersburg, Russia, 196084
    • Medical Research Institute LLC
  • Saint Petersburg, Russia, 191014
    • SPb SBHI "Snegirev Maternity Hospital No. 6"
  • Yaroslavl, Russia, 150003
    • Solovyev Clinical Emergency Hospital
  • Yaroslavl, Russia, 150003
    • Solovyov Clinical Emergency Hospital
• Slovakia
  • 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.
• South Africa
  • Gauteng
    • Benoni, Gauteng, South Africa, 1501
      • Diabetes Care Centre & CDE Centre
    • Benoni, Gauteng, South Africa, 1501
      • East Rand Physicians
    • Johannesburg, Gauteng, South Africa, 2198
      • Centre for Diabetes
    • Johannesburg, Gauteng, South Africa, 1501
      • East Rand Physicians
  • KwaZulu-Natal
    • Durban, KwaZulu-Natal, South Africa, 4450
      • Dr Pillay's Rooms
    • Durban, KwaZulu-Natal, South Africa, 4450
      • Dr J Reddy
    • eMkhomazi, KwaZulu-Natal, South Africa, 4170
      • Dr T Padayachee
• Spain
  • Almería, Spain, 04009
    • Centro Periferico De Especialidades Bola Azul
  • La Roca Del Vallés, Spain, 08430
    • ABS La Roca del Vallés
  • La Roca Del Vallés, Spain, 08430
    • ABS La Roca del Vallés_Endocrinología
  • Madrid, Spain, 28031
    • Hospital Infanta Leonor
  • Palma de Mallorca, Spain, 07120
    • Hospital Son Espases
  • Seville, Spain, 41010
    • H. Infanta Luisa_Endocrino y Obesidad
• 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
• United States
  • Alabama
    • Sheffield, Alabama, United States, 35660
      • Shoals Primary Care
  • Arizona
    • Glendale, Arizona, United States, 85308
      • Lenzmeier Fam Med CCT Research
    • Mesa, Arizona, United States, 85213
      • Synexus Clinical Research US, Inc./Desert Clinical Research,
  • Arkansas
    • Searcy, Arkansas, United States, 72143
      • Unity Health-Searcy Medical Center
    • Searcy, Arkansas, United States, 72143
      • OneLife Direct Care Inc.
  • California
    • Canoga Park, California, United States, 91304
      • San Fernando Valley Hlth Inst, LLC
    • Chula Vista, California, United States, 91911
      • Velocity Clin Res-Chula Vista
    • Concord, California, United States, 94520
      • John Muir Physicians Network
    • Fresno, California, United States, 93720
      • Valley Research
    • Fullerton, California, United States, 92835
      • Providence Medical Foundation
    • Fullerton, California, United States, 92835
      • Ascada Research
    • Huntington Park, California, United States, 90255
      • Velocity Clinical Research Huntington Park
    • La Jolla, California, United States, 92037
      • Scripps Memorial Hospital La Jolla
    • La Mesa, California, United States, 91942
      • Velocity Clin Res San Diego
    • Lancaster, California, United States, 93534
      • First Valley Medical Group
    • Loma Linda, California, United States, 92354
      • Loma Linda Univ Hlth Cr Endo
    • Lomita, California, United States, 90717
      • Torrance Clin Res Inst, Inc.
    • Los Angeles, California, United States, 90017
      • Downtown LA Res Ctr. Inc.
    • Los Angeles, California, United States, 90015
      • NRC Research Institute
    • Los Angeles, California, United States, 90017
      • Velocity Clin Res Los Angeles
    • Northridge, California, United States, 91325
      • Valley Clinical Trials, Inc.
    • San Diego, California, United States, 92120
      • Wetlin Research Associates, Inc.
    • San Diego, California, United States, 92111
      • San Diego Family Care_San Diego
    • Tustin, California, United States, 92780
      • University Clin Investigators
  • Colorado
    • Denver, Colorado, United States, 80209
      • Velocity Clin Res, Denver
  • Connecticut
    • Waterbury, Connecticut, United States, 06708
      • Chase Medical Research LLC
  • Florida
    • Hialeah, Florida, United States, 33012
      • Indago Research & Health Center Inc.
    • Hollywood, Florida, United States, 33024
      • Encore Medical Research LLC
    • Jacksonville, Florida, United States, 32216
      • Jacksonville Ctr For Clin Res
    • Jacksonville, Florida, United States, 32204
      • Northeast Res Inst. Inc.
    • Jacksonville, Florida, United States, 32277
      • Care-Partners-Clinical-Research, LLC
    • Miami, Florida, United States, 33165
      • New Horizon Research Center
    • Miami, Florida, United States, 33135
      • Suncoast Research Group, LLC
    • Miami, Florida, United States, 33175
      • Reyes Clinical Research, Inc
    • Miami, Florida, United States, 33183
      • International Research Associates, LLC_Miami
    • Miami, Florida, United States, 33169
      • Elite Research Center
    • Miami, Florida, United States, 33175
      • Diverse Clinical Research Miami
    • Miramar, Florida, United States, 33027
      • South Broward Research LLC
    • New Port Richey, Florida, United States, 34652
      • Suncoast Clinical Research, Inc._New Port Richey
    • New Port Richey, Florida, United States, 34652
      • Suncoast Clin Res Port Richey
    • Ocala, Florida, United States, 34470
      • Renstar Medical Research
    • Tampa, Florida, United States, 33607
      • Clinical Research Trials of Florida
  • Georgia
    • Atlanta, Georgia, United States, 30329-4015
      • CVS Store Number: 7689
    • Canton, Georgia, United States, 30114
      • East Coast Institute for Res
    • Hinesville, Georgia, United States, 31313
      • Coastal Heritage Clinical Research
    • Macon, Georgia, United States, 31210
      • East Coast Institute for Res
    • Roswell, Georgia, United States, 30076
      • Endocrine Research Solutions
    • Savannah, Georgia, United States, 31405-6901
      • CVS Store Number: 05520
  • Idaho
    • Meridian, Idaho, United States, 83646
      • Solaris Clinical Research
  • Illinois
    • Chicago, Illinois, United States, 60607
      • Cedar-Crosse Research Center
    • Chicago, Illinois, United States, 60661
      • WellNow Urgent Care
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • Brengle Family Medicine
  • Iowa
    • Council Bluffs, Iowa, United States, 51501
      • West Broadway Clinic
    • West Des Moines, Iowa, United States, 50265
      • Iowa Diab & Endo Res Center
    • West Des Moines, Iowa, United States, 50266
      • Iowa Diab & Endo Res Center
  • Kansas
    • Topeka, Kansas, United States, 66606
      • Cotton O'Neil Diab & Endo Ctr
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • The Research Group of Lexington LLC
    • Louisville, Kentucky, United States, 40213
      • L-MARC Research Center
  • Louisiana
    • Monroe, Louisiana, United States, 71203
      • Arthritis And Diabetes Clinic, Inc.
    • New Orleans, Louisiana, United States, 70119
      • AMR New Orleans
    • Slidell, Louisiana, United States, 70461
      • Ileana J. Tandron, MD APMC (a private medical office)
  • Maryland
    • Hyattsville, Maryland, United States, 20782
      • MedStar Hlth Res Institute
    • Rockville, Maryland, United States, 20852
      • Endo And Metab Cons
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Joslin Diabetes Center
    • Boston, Massachusetts, United States, 02115
      • Brigham & Women's Hospital
  • Michigan
    • Buckley, Michigan, United States, 49620
      • Northern Pines Hlth Ctr, PC
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
    • Flint, Michigan, United States, 48532
      • Elite Research Center
    • Troy, Michigan, United States, 48098
      • Arcturus HC PLC Troy Med Res
  • Missouri
    • City of Saint Peters, Missouri, United States, 63303
      • StudyMetrix Research LLC
  • Montana
    • Butte, Montana, United States, 59701
      • Mercury Str Med Grp, PLLC
  • Nebraska
    • Elkhorn, Nebraska, United States, 68022
      • Clinical Research Advantage, Inc./Skyline Medical Center, PC
    • Fremont, Nebraska, United States, 68025
      • Methodist Physicians Clinic
    • Norfolk, Nebraska, United States, 68701
      • Velocity Clin Res, Norfolk
    • Omaha, Nebraska, United States, 68144
      • Midwest Regional Health Services
    • Omaha, Nebraska, United States, 68198-3020
      • Univ of Nebraska Medical CTR
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • Palm Research Center Inc-Vegas
  • New Hampshire
    • Nashua, New Hampshire, United States, 03060
      • Southern New Hampshire Diabetes and Endocrinology
  • New Jersey
    • Trenton, New Jersey, United States, 08611
      • Premier Research Inc.
  • New York
    • Albany, New York, United States, 12203
      • AMC Community Endocrinology
    • Brooklyn, New York, United States, 11229
      • Dr. Alexander Perkelvald
    • New Windsor, New York, United States, 12553
      • Mid Hudson Med Res-New Windsor
    • Westfield, New York, United States, 14787
      • Great Lakes Medical Research
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • University of North Carolina Medical Center
    • Greenville, North Carolina, United States, 27834
      • Physicians East Endocrinology
    • Morehead City, North Carolina, United States, 28557
      • Carteret Medical Group
    • Morehead City, North Carolina, United States, 28557
      • Centricity Rsrch MHCity Multi
  • North Dakota
    • Fargo, North Dakota, United States, 58104
      • Lillestol Research LLC
  • Ohio
    • Beachwood, Ohio, United States, 44122
      • Velocity Clin Res Cleveland
    • Canton, Ohio, United States, 44718
      • Diab & Endo Assoc of Stark Co
    • Cincinnati, Ohio, United States, 45219
      • Velocity Clin Res_Cincinnati
    • Mason, Ohio, United States, 45040
      • Albert J Weisbrot
    • Maumee, Ohio, United States, 43537
      • Advanced Med Res Maumee
    • Toledo, Ohio, United States, 43614
      • University of Toledo Medical Center
    • Toledo, Ohio, United States, 43614
      • University of Toledo_Toledo
  • Oklahoma
    • Norman, Oklahoma, United States, 73069
      • Lynn Institute of Norman
    • Norman, Oklahoma, United States, 73069
      • Intend Research
  • Oregon
    • Medford, Oregon, United States, 97504
      • Velocity Clinical Res Medford
  • Pennsylvania
    • Beaver, Pennsylvania, United States, 15009
      • Heritage Valley Multispeciality Group Inc
    • Johnstown, Pennsylvania, United States, 15905
      • Richard M Kastelic MD Assoc
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University
    • Uniontown, Pennsylvania, United States, 15401
      • Preferred Primary Care Physicians, Inc.
  • South Carolina
    • Myrtle Beach, South Carolina, United States, 29572
      • Carolina Health Specialists
    • Summerville, South Carolina, United States, 29485
      • Palmetto Clinical Research
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Chattanooga Medical Research, LLC
    • Chattanooga, Tennessee, United States, 37411
      • Univ Diab & Endo Consultants
    • Jackson, Tennessee, United States, 38305
      • Jackson Clinic
    • Kingsport, Tennessee, United States, 37660
      • Holston Medical Group
    • Knoxville, Tennessee, United States, 37938
      • Accellacare US Inc., d/b/a Accellacare of Knoxville
    • Memphis, Tennessee, United States, 38119
      • Clinical Neuroscience Solutions
  • Texas
    • Amarillo, Texas, United States, 79106
      • Amarillo Med Spec LLP
    • Arlington, Texas, United States, 76012-4637
      • Arlington Family Res. Ctr Inc
    • Austin, Texas, United States, 78705
      • Central Texas Clinical Research
    • Cedar Park, Texas, United States, 78613
      • Velocity Clin Res Austin
    • Dallas, Texas, United States, 75230
      • Velocity Clinical Res-Dallas
    • Dallas, Texas, United States, 75208
      • Thyroid Endocrinology & Diabetes PA
    • El Paso, Texas, United States, 79935
      • Academy of Diabetes, T&E
    • Fort Worth, Texas, United States, 76132
      • Diabetes and Thyroid Ctr of FW
    • Houston, Texas, United States, 77074
      • Houston Institute for Clinical Research
    • Houston, Texas, United States, 77040
      • JCCT- Juno NW Houston
    • Houston, Texas, United States, 77029
      • Gonzalez Family & Occupational Medicine
    • Hurst, Texas, United States, 76054
      • Protenium Clinical Research
    • Longview, Texas, United States, 75605
      • DCOL Ctr for Clin Res
    • McKinney, Texas, United States, 75069
      • Tekton Research
    • Plano, Texas, United States, 75075
      • Clinical Investigations of Texas
    • San Antonio, Texas, United States, 78230
      • VIP Trials
    • San Antonio, Texas, United States, 78224
      • Briggs Clinical Research, LLC
    • San Antonio, Texas, United States, 78220
      • San Antonio Prem Int Med
    • San Antonio, Texas, United States, 78229
      • Diabetes Glandular Diseases Clinic
    • San Antonio, Texas, United States, 78240
      • Diabetes Glandular Diseases Clinic
    • Shavano Park, Texas, United States, 78231
      • Consano Clinical Research, LLC
    • Sugar Land, Texas, United States, 77479
      • Med-Olam Clinical Reseach LLC
    • Waco, Texas, United States, 76708
      • Hillcrest Family Health Center
  • Utah
    • Ogden, Utah, United States, 84405
      • Advanced Research Institute
    • Ogden, Utah, United States, 84405
      • South Ogden Family Medicine/ CCT Research
    • Salt Lake City, Utah, United States, 84117
      • Olympus Family Medicine
    • St. George, Utah, United States, 84790
      • Chrysalis Clinical Research
    • West Jordan, Utah, United States, 84088
      • Velocity Clin Res-Salt Lk City
  • Virginia
    • Chesapeake, Virginia, United States, 23321
      • Virginia Endo Res, LLC
    • Norfolk, Virginia, United States, 23504
      • York Clinical Research LLC
    • Reston, Virginia, United States, 20191-4327
      • CVS Store Number: 01396
    • Richmond, Virginia, United States, 23230-3005
      • CVS Store Number: 1537
    • Winchester, Virginia, United States, 22601
      • Amherst Family Practice P.C.
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • WVU Medicine
  • Wisconsin
    • Green Bay, Wisconsin, United States, 54303
      • Prevea Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosed with Type 2 Diabetes Mellitus (T2D) mellitus greater than or equal to (>=) 180 days before screening.
• Glycated haemoglobin (HbA1c) of 7-10 percentage [(53-86 millimoles per mole (mmol/mol)] (both inclusive) as assessed by central laboratory on the day of screening.
• Body mass index (BMI) greater than or equal to (>=) 25 kilograms per meter square (kg/m^2) on the day of screening.
• Stable daily dose(s) greater than or equal to (>=) 90 days before screening of any of the following anti-diabetic drugs or combination regimens:
• Any metformin formulations greater than or equal to (>=) 1500 milligrams (mg) or maximum tolerated or effective dose.
• Any metformin combination formulation greater than or equal to (>=) 1500 mg or maximum tolerated or effective dose.

The treatment can be with or without sodium glucose cotransporter 2 (SGLT-2) inhibitors.

• Treated with a once daily basal insulin (e.g. insulin glargine Unit 100 or U300, neutral protamine hagedorn (NPH) insulin, insulin detemir, insulin degludec) less than or equal to (<=) 40 units/day (U/day) for greater than or equal to (>=) 90 days before screening. Short-term bolus insulin treatment for a maximum of 14 days before screening is allowed.

Exclusion Criteria:

• Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
• Potentially missed diagnosis of Type 1 diabetes (T1D) or latent autoimmune diabetes in adults (LADA) verified by C-peptide less than 0.26 nanomoles per litre (nmol/L) (or 260 picomoles per liter [pmol/L] [0.78 nanograms per millilitre {ng/mL}]) or antibodies to glutamic acid decarboxylase (anti-GAD) greater than 5 units/millilitre, as measured by the central laboratory at screening.
• Presence or history of pancreatitis (acute or chronic).
• Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of less than 30 millilitre per minute per 1.73 meter square at screening as defined by Kidney Disease: Improving Global Outcomes (KDIGO) 2012 classification.
• Any episodes of diabetic ketoacidosis within 90 days before screening.
• Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire question 8.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Insuline glargine U100 (reduced) + semaglutide; Participants will initially receive 0.25 milligrams (mg) once-weekly semaglutide subcutaneously (s.c.) and the dose will be gradually escalated to 2 mg as an add-on to dose-reduced insulin glargine s.c. given once-daily. Insulin glargine U100 will be reduced by 10 U at the initiation of semaglutide and then again at each semaglutide dose escalation. Insulin glargine dose will be adjusted based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values (target SMPG: 4.4-7.2 millimoles per litre (mmol/L)).	Drug: Semaglutide; Participants will receive once-weekly semaglutide s.c. for 40 weeks. Semaglutide 0.25 mg will be given at week 0 and then the dose will be escalated at weeks 4, 8 and 12 to 0.5 mg, 1 mg, 2 mg respectively.; Drug: Insuline glargine U100 (reduced); Participants will receive insulin glargine U100 s.c. once-daily. Insulin glargine dose will be reduced by 10 U at initiation of semaglutide and then again at each semaglutide dose escalation up to 40 weeks. The dose will be adjusted based on the mean of three pre-breakfast SMPG values (target SMPG: 4.4-7.2 mmol/L).
Active Comparator: Insuline glargine U100 (titrated); Participants will receive titrated insuline glargine U100 s.c. once-daily. Insulin glargine U100 dose will be adjusted based on the mean of three pre-breakfast SMPG values (target SMPG: 4.4-7.2 mmol/L).	Drug: Insuline glargine U100 (titrated); Participants will receive titrated insulin glargine U100 s.c. once-daily up to 40 weeks. The dose will be adjusted based on the mean of three pre-breakfast SMPG values (target SMPG: 4.4-7.2 mmol/L).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Glycated Haemoglobin (HbA1c) [Noninferiority]	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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Body Weight	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	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]	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)	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)	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%	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%	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)	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)	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)	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	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)	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)	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)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2022
• Primary Completion (Actual): March 5, 2025
• Study Completion (Actual): April 9, 2025

Study Registration Dates

• First Submitted: August 22, 2022
• First Submitted That Met QC Criteria: August 22, 2022
• First Posted (Actual): August 24, 2022

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Glucose Metabolism Disorders; Diabetes Mellitus; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Diabetes Mellitus, Type 2; Glucagon-Like Peptide-1 Receptor Agonists; Physiological Effects of Drugs; Hypoglycemic Agents; semaglutide
• Other Study ID Numbers: NN9535-4801; U1111-1267-0312 (Other Identifier: World Health Organization (WHO)); 2021-004392-13 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No