AzTrials
AzTrials

Diabetes Mellitus, Type 2Phase 3NCT05514535

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)

A Phase 3 study testing Semaglutide, Insuline glargine U100 (reduced) and Insuline glargine U100 (titrated) in people with Diabetes Mellitus, Type 2 and Obesity, run by Novo Nordisk A/S at 239 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Type 2, Obesity
What is being tested?
Semaglutide, Insuline glargine U100 (reduced) and Insuline glargine U100 (titrated)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
573 participants
Where
239 sitesin 12 countries
Study dates
29 Aug 2022to 9 Apr 2025
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

239 sites in 12 countries.

239 sites in 12 countries

United States145 sites

  • AMC Community Endocrinology

    Albany, New York, 12203

  • Amarillo Med Spec LLP

    Amarillo, Texas, 79106

  • Arlington Family Res. Ctr Inc

    Arlington, Texas, 76012-4637

  • CVS Store Number: 7689

    Atlanta, Georgia, 30329-4015

  • Central Texas Clinical Research

    Austin, Texas, 78705

  • Velocity Clin Res Cleveland

    Beachwood, Ohio, 44122

  • Heritage Valley Multispeciality Group Inc

    Beaver, Pennsylvania, 15009

  • Brigham & Women's Hospital

    Boston, Massachusetts, 02115

  • Joslin Diabetes Center

    Boston, Massachusetts, 02215

  • Dr. Alexander Perkelvald

    Brooklyn, New York, 11229

  • Northern Pines Hlth Ctr, PC

    Buckley, Michigan, 49620

  • Mercury Str Med Grp, PLLC

    Butte, Montana, 59701

  • San Fernando Valley Hlth Inst, LLC

    Canoga Park, California, 91304

  • East Coast Institute for Res

    Canton, Georgia, 30114

  • Diab & Endo Assoc of Stark Co

    Canton, Ohio, 44718

  • Velocity Clin Res Austin

    Cedar Park, Texas, 78613

  • University of North Carolina Medical Center

    Chapel Hill, North Carolina, 27514

  • Chattanooga Medical Research, LLC

    Chattanooga, Tennessee, 37404

  • Univ Diab & Endo Consultants

    Chattanooga, Tennessee, 37411

  • Virginia Endo Res, LLC

    Chesapeake, Virginia, 23321

  • Cedar-Crosse Research Center

    Chicago, Illinois, 60607

  • WellNow Urgent Care

    Chicago, Illinois, 60661

  • Velocity Clin Res-Chula Vista

    Chula Vista, California, 91911

  • Velocity Clin Res_Cincinnati

    Cincinnati, Ohio, 45219

  • StudyMetrix Research LLC

    City of Saint Peters, Missouri, 63303

  • John Muir Physicians Network

    Concord, California, 94520

  • West Broadway Clinic

    Council Bluffs, Iowa, 51501

  • Thyroid Endocrinology & Diabetes PA

    Dallas, Texas, 75208

  • Velocity Clinical Res-Dallas

    Dallas, Texas, 75230

  • Velocity Clin Res, Denver

    Denver, Colorado, 80209

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Academy of Diabetes, T&E

    El Paso, Texas, 79935

  • Clinical Research Advantage, Inc./Skyline Medical Center, PC

    Elkhorn, Nebraska, 68022

  • Lillestol Research LLC

    Fargo, North Dakota, 58104

  • Elite Research Center

    Flint, Michigan, 48532

  • Diabetes and Thyroid Ctr of FW

    Fort Worth, Texas, 76132

  • Methodist Physicians Clinic

    Fremont, Nebraska, 68025

  • Valley Research

    Fresno, California, 93720

  • Ascada Research

    Fullerton, California, 92835

  • Providence Medical Foundation

    Fullerton, California, 92835

  • Lenzmeier Fam Med CCT Research

    Glendale, Arizona, 85308

  • Prevea Health

    Green Bay, Wisconsin, 54303

  • Physicians East Endocrinology

    Greenville, North Carolina, 27834

  • Indago Research & Health Center Inc.

    Hialeah, Florida, 33012

  • Coastal Heritage Clinical Research

    Hinesville, Georgia, 31313

  • Encore Medical Research LLC

    Hollywood, Florida, 33024

  • Gonzalez Family & Occupational Medicine

    Houston, Texas, 77029

  • JCCT- Juno NW Houston

    Houston, Texas, 77040

  • Houston Institute for Clinical Research

    Houston, Texas, 77074

  • Velocity Clinical Research Huntington Park

    Huntington Park, California, 90255

  • Protenium Clinical Research

    Hurst, Texas, 76054

  • MedStar Hlth Res Institute

    Hyattsville, Maryland, 20782

  • Brengle Family Medicine

    Indianapolis, Indiana, 46260

  • Jackson Clinic

    Jackson, Tennessee, 38305

  • Northeast Res Inst. Inc.

    Jacksonville, Florida, 32204

  • Jacksonville Ctr For Clin Res

    Jacksonville, Florida, 32216

  • Care-Partners-Clinical-Research, LLC

    Jacksonville, Florida, 32277

  • Richard M Kastelic MD Assoc

    Johnstown, Pennsylvania, 15905

  • Holston Medical Group

    Kingsport, Tennessee, 37660

  • Accellacare US Inc., d/b/a Accellacare of Knoxville

    Knoxville, Tennessee, 37938

  • Scripps Memorial Hospital La Jolla

    La Jolla, California, 92037

  • Velocity Clin Res San Diego

    La Mesa, California, 91942

  • First Valley Medical Group

    Lancaster, California, 93534

  • Palm Research Center Inc-Vegas

    Las Vegas, Nevada, 89128

  • The Research Group of Lexington LLC

    Lexington, Kentucky, 40503

  • Loma Linda Univ Hlth Cr Endo

    Loma Linda, California, 92354

  • Torrance Clin Res Inst, Inc.

    Lomita, California, 90717

  • DCOL Ctr for Clin Res

    Longview, Texas, 75605

  • NRC Research Institute

    Los Angeles, California, 90015

  • Downtown LA Res Ctr. Inc.

    Los Angeles, California, 90017

  • Velocity Clin Res Los Angeles

    Los Angeles, California, 90017

  • L-MARC Research Center

    Louisville, Kentucky, 40213

  • East Coast Institute for Res

    Macon, Georgia, 31210

  • Albert J Weisbrot

    Mason, Ohio, 45040

  • Advanced Med Res Maumee

    Maumee, Ohio, 43537

  • Tekton Research

    McKinney, Texas, 75069

  • Velocity Clinical Res Medford

    Medford, Oregon, 97504

  • Clinical Neuroscience Solutions

    Memphis, Tennessee, 38119

  • Solaris Clinical Research

    Meridian, Idaho, 83646

  • Synexus Clinical Research US, Inc./Desert Clinical Research,

    Mesa, Arizona, 85213

  • Suncoast Research Group, LLC

    Miami, Florida, 33135

  • New Horizon Research Center

    Miami, Florida, 33165

  • Elite Research Center

    Miami, Florida, 33169

  • Diverse Clinical Research Miami

    Miami, Florida, 33175

  • Reyes Clinical Research, Inc

    Miami, Florida, 33175

  • International Research Associates, LLC_Miami

    Miami, Florida, 33183

  • South Broward Research LLC

    Miramar, Florida, 33027

  • Arthritis And Diabetes Clinic, Inc.

    Monroe, Louisiana, 71203

  • Carteret Medical Group

    Morehead City, North Carolina, 28557

  • Centricity Rsrch MHCity Multi

    Morehead City, North Carolina, 28557

  • WVU Medicine

    Morgantown, West Virginia, 26506

  • Carolina Health Specialists

    Myrtle Beach, South Carolina, 29572

  • Southern New Hampshire Diabetes and Endocrinology

    Nashua, New Hampshire, 03060

  • AMR New Orleans

    New Orleans, Louisiana, 70119

  • Suncoast Clin Res Port Richey

    New Port Richey, Florida, 34652

  • Suncoast Clinical Research, Inc._New Port Richey

    New Port Richey, Florida, 34652

  • Mid Hudson Med Res-New Windsor

    New Windsor, New York, 12553

  • Velocity Clin Res, Norfolk

    Norfolk, Nebraska, 68701

  • York Clinical Research LLC

    Norfolk, Virginia, 23504

  • Intend Research

    Norman, Oklahoma, 73069

  • Lynn Institute of Norman

    Norman, Oklahoma, 73069

  • Valley Clinical Trials, Inc.

    Northridge, California, 91325

  • Renstar Medical Research

    Ocala, Florida, 34470

  • Advanced Research Institute

    Ogden, Utah, 84405

  • South Ogden Family Medicine/ CCT Research

    Ogden, Utah, 84405

  • Midwest Regional Health Services

    Omaha, Nebraska, 68144

  • Univ of Nebraska Medical CTR

    Omaha, Nebraska, 68198-3020

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Clinical Investigations Of Texas

    Plano, Texas, 75075

  • CVS Store Number: 01396

    Reston, Virginia, 20191-4327

  • CVS Store Number: 1537

    Richmond, Virginia, 23230-3005

  • Endo And Metab Cons

    Rockville, Maryland, 20852

  • Endocrine Research Solutions

    Roswell, Georgia, 30076

  • Olympus Family Medicine

    Salt Lake City, Utah, 84117

  • San Antonio Prem Int Med

    San Antonio, Texas, 78220

  • Briggs Clinical Research, LLC

    San Antonio, Texas, 78224

  • Diabetes Glandular Diseases Clinic

    San Antonio, Texas, 78229

  • VIP Trials

    San Antonio, Texas, 78230

  • Diabetes Glandular Diseases Clinic

    San Antonio, Texas, 78240

  • San Diego Family Care_San Diego

    San Diego, California, 92111

  • Wetlin Research Associates, Inc.

    San Diego, California, 92120

  • CVS Store Number: 05520

    Savannah, Georgia, 31405-6901

  • OneLife Direct Care Inc.

    Searcy, Arkansas, 72143

  • Unity Health-Searcy Medical Center

    Searcy, Arkansas, 72143

  • Consano Clinical Research, LLC

    Shavano Park, Texas, 78231

  • Shoals Primary Care

    Sheffield, Alabama, 35660

  • Ileana J. Tandron, MD APMC (a private medical office)

    Slidell, Louisiana, 70461

  • Chrysalis Clinical Research

    St. George, Utah, 84790

  • Med-Olam Clinical Reseach LLC

    Sugar Land, Texas, 77479

  • Palmetto Clinical Research

    Summerville, South Carolina, 29485

  • Clinical Research Trials of Florida

    Tampa, Florida, 33607

  • University of Toledo Medical Center

    Toledo, Ohio, 43614

  • University of Toledo_Toledo

    Toledo, Ohio, 43614

  • Cotton O'Neil Diab & Endo Ctr

    Topeka, Kansas, 66606

  • Premier Research Inc.

    Trenton, New Jersey, 08611

  • Arcturus HC PLC Troy Med Res

    Troy, Michigan, 48098

  • University Clin Investigators

    Tustin, California, 92780

  • Preferred Primary Care Physicians, Inc.

    Uniontown, Pennsylvania, 15401

  • Hillcrest Family Health Center

    Waco, Texas, 76708

  • Chase Medical Research LLC

    Waterbury, Connecticut, 06708

  • Iowa Diab & Endo Res Center

    West Des Moines, Iowa, 50265

  • Iowa Diab & Endo Res Center

    West Des Moines, Iowa, 50266

  • Velocity Clin Res-Salt Lk City

    West Jordan, Utah, 84088

  • Great Lakes Medical Research

    Westfield, New York, 14787

  • Amherst Family Practice P.C.

    Winchester, Virginia, 22601

Other trials in United States

Romania16 sites

  • CMI Dr Pop Lavinia

    Baia Mare, Maramureş, 430222

  • Clinica Grivitei 224 S.R.L.

    Brăila, 810197

  • Mariodiab Clinic SRL

    Brasov, 500101

  • Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed

    Brasov, 500283

  • Diabs&Nutricare Srl

    Bucharest, 040172

  • Clinic of Diabetes Constanta

    Constanța, 900591

  • Clinical Emergency Sf. Apostol Andrei Hospital

    Galati, 800578

  • SC Consultmed SRL

    Iași, 700547

  • Medical Practice SRL

    Oradea, Bihor County, 410001

  • Grandmed SRL

    Oradea, Bihor County, 410159

  • Novus Medical Clinica SRL

    Ploieşti, Prahova, 100018

  • S.C. Dianutrilife Medica S.R.L.

    Ploieşti, 100561

  • Clinica Korall S.R.L. Satu Mare

    Satu Mare, 440055

  • Spitalul Judetean de Urgenta Targoviste

    Targoviste, Dâmbovița County, 130083

  • Dentosim Queen Srl

    Târgu Mureş, 540098

  • Centrul Medical Sfantul Stefan

    Timișoara, Timiș County, 300125

Other trials in Romania

Slovakia13 sites

  • DIA - CLARUS s.r.o.

    Bojnice, 97201

  • MediTask, s.r.o

    Bratislava, 83103

  • MEDISPEKTRUM s.r.o.

    Bratislava, 851 01

  • DIA-MAX s.r.o.

    Levice, 93401

  • IN-DIA s.r.o.

    Lučenec, 984 01

  • DIA - SANTMART, s.r.o., Ambulancia diabetologie a poruch latkovej premeny a vyzivy

    Martin, 036 01

  • FUNKYSTUFF s.r.o

    Nové Zámky, 940 59

  • Diakom, spol. s r.o.

    Poprad, 05801

  • DIALIPID, s.r.o.

    Prešov, 080 01

  • Tatratrial s.r.o.

    Rožňava, 04801

  • Amb. Diabetologie a prouch latkovej premeny a vyzivy ENDIANT s.r.o.

    Sereď, 926 01

  • BENROD s.r.o.

    Štúrovo, 943 01

  • MUDr. Korecova, metabolicke centrum s.r.o.

    Trenčín, 911 01

Other trials in Slovakia

Greece12 sites

  • University Hospital of Alexandroupolis

    Alexandroupoli, 68100

  • University Hospital of Athens ATTIKON

    Athens, Attica, 12462

  • "Laiko" General Hospital of Athens

    Athens, 11527

  • Alexandra General Hospital, Therapeutic Clinic

    Athens, 11528

  • Alexandra General Hospital, Therapeutic Clinic

    Athens, GR-11528

  • Geniko Nosokomeio Nikaias Peiraia Ag. Panteleimon Geniko Nosokomeio Dytikis Attikis I - Diabetes Department

    Nikaia, GR-18454

  • Geniko Nosokomeio Peiraia Tzaneio

    Piraeus, 18536

  • AHEPA General University Hospital

    Thessaloniki, 54636

  • EUROMEDICA Gen Clinic The/ki, Endocrin,Metabolism,Diabetes

    Thessaloniki, 54645

  • "Thermi" Private Hosital

    Thessaloniki, 57001

  • General Hospital of Thessaloniki "G.Papanikolaou"

    Thessaloniki, 57010

  • "Thermi" Private Hosital

    Thessaloniki, GR-57001

Other trials in Greece

Italy11 sites

  • Azienda Ospedaliera Papa Giovanni XXIII

    Bergamo, 24127

  • Policlinico Mater Domini Università di Catanzaro

    Catanzaro, 88100

  • Ospedale Santa Maria Goretti - UOD Diabetologia

    Latina, LT, 04100

  • Azienda Unita' Sanitaria Locale Toscana Nord Ovest - Cittadella della Salute Campo di Marte

    Lucca, LU, 55100

  • Istituto Scientifico San Raffaele

    Milan, MI, 20132

  • ASST degli Spedali Civili di Brescia-Presidio Ospedaliero di Montichiari

    Montichiari, 25018

  • A.O.U. Università Studi della Campania "Luigi Vanvitelli"

    Naples, Campania, 80138

  • A.O.U. Università Studi della Campania "Luigi Vanvitelli"

    Naples, 80138

  • Azienda Ospedaliera di Perugia;Ospedale S. Maria della Misericordia

    Perugia, Umbria, 06129

  • Policlinico Umberto I Seconda Clinica Medica

    Roma, RM, 00161

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Dipartimento di scienze Mediche e Chirurgiche

    Rome, 00168

Other trials in Italy

Portugal11 sites

  • ULS De Almada-Seixal E.P.E. - Hospital Garcia de Orta

    Almada, 2805-267

  • ULS Da Regiao De Aveiro E.P.E. - Hospital Infante D. Pedro

    Aveiro, 3814-501

  • ULS De Braga, E.P.E. - Hospital de Braga

    Braga, 4710-243

  • ULS Do Oeste E.P.E. - Unidade Caldas da Rainha

    Caldas da Rainha, 2500-176

  • ULS Da Região De Leiria E.P.E.- Hospital de Santo André

    Leiria, 2410-197

  • Unidade Local De Saúde De São José, E.P.E. - Hospital Curry Cabral

    Lisbon, 1050-099

  • Unidade Local De Saúde De Lisboa Ocidental E.P.E. - Hospital Egas Moniz

    Lisbon, 1349-019

  • ULS De Santo António, E.P.E. - Hospital de Santo António

    Porto, 4099-001

  • ULS De São João, E.P.E. - Hospital de São João

    Porto, 4200-319

  • ULS De Matosinhos E.P.E.- Hospital Pedro Hispano

    Senhora Da Hora, Matosinhos, Matosinhos, 4464-513

  • ULS Do Alto Minho E.P.E. - Hospital de Santa Luzia

    Viana do Castelo, 4904-858

Other trials in Portugal

Russia7 sites

  • Volosevich First City Clinical Hospital

    Arkhangelsk, 163001

  • SPb SBHI "Snegirev Maternity Hospital No. 6"

    Saint Petersburg, 191014

  • Medinet LLC

    Saint Petersburg, 194356

  • SPb SBHI City polyclinic #117

    Saint Petersburg, 194358

  • Medical Research Institute LLC

    Saint Petersburg, 196084

  • Solovyev Clinical Emergency Hospital

    Yaroslavl, 150003

  • Solovyov Clinical Emergency Hospital

    Yaroslavl, 150003

Other trials in Russia

South Africa7 sites

  • Diabetes Care Centre & CDE Centre

    Benoni, Gauteng, 1501

  • East Rand Physicians

    Benoni, Gauteng, 1501

  • Dr J Reddy

    Durban, KwaZulu-Natal, 4450

  • Dr Pillay's Rooms

    Durban, KwaZulu-Natal, 4450

  • Dr T Padayachee

    eMkhomazi, KwaZulu-Natal, 4170

  • East Rand Physicians

    Johannesburg, Gauteng, 1501

  • Centre for Diabetes

    Johannesburg, Gauteng, 2198

Other trials in South Africa

Czechia6 sites

  • EDUMED s.r.o.

    Náchod, 547 01

  • Diahelp - diabetologie

    Pardubice, 530 02

  • MUDr. Jitka Zemanova - diabetologie a interna, s.r.o.

    Plzen - Vychodni Predmesti, 326 00

  • Diabet2 s.r.o.

    Prague, 110 00

  • MUDr. Michala Pelikanova

    Prague, 140 00

  • ResTrial s.r.o.

    Prague, 18100

Other trials in Czechia

Spain6 sites

  • Centro Periférico de Especialidades Bola Azul

    Almería, 04009

  • ABS La Roca del Vallés_Endocrinología

    La Roca Del Vallés, 08430

  • ABS La Roca del Vallés

    La Roca Del Vallés, 08430

  • Hospital Infanta Leonor

    Madrid, 28031

  • Hospital Son Espases

    Palma de Mallorca, 07120

  • H. Infanta Luisa_Endocrino y Obesidad

    Seville, 41010

Other trials in Spain

Ukraine4 sites

  • Kharkiv Regional Clinical Hospital - Endocrinology department

    Kharkiv, 61058

  • Khmelnytskyi Regional Hospital - Endocrinology department

    Khmelnytskyi, 29000

  • Ternopil Central District Hospital - Outpatient department

    Ternopil, 46001

  • Medical centre"Elitmedservis"LLC

    Zaporizhzhya, 69037

Other trials in Ukraine

Puerto Rico1 site

  • Caribbean Medical Research Center

    San Juan, 00918

Other trials in Puerto Rico

About this study

Official title: 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.

Being tested
Semaglutide, Insuline glargine U100 (reduced), Insuline glargine U100 (titrated)
Medical subject headings
Diabetes Mellitus, Type 2, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SemaglutideDrug

    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.

  • Insuline glargine U100 (reduced)Drug

    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).

  • Insuline glargine U100 (titrated)Drug

    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).

Study groups in NCT05514535
Study groupRoleWhat they receive
Insuline glargine U100 (reduced) + semaglutideExperimentalParticipants 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)).
Receives: Drug: Semaglutide; Drug: Insuline glargine U100 (reduced)
Insuline glargine U100 (titrated)Active comparatorParticipants 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).
Receives: Drug: Insuline glargine U100 (titrated)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From baseline (week 0) to end of treatment (week 40)

Secondary outcomes (13)

  1. 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)'.

    Measured: From baseline (week 0) to end of treatment (week 40)

  2. 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.

    Measured: From baseline (week 0) to end of treatment (week 40)

  3. Change in Glycated Haemoglobin (HbA1c ) [Superiority]

    Change in HbA1c (Superiority) from baseline (Week 0) to end of treatment (Week 40) were reported.

    Measured: From baseline (week 0) to end of treatment (week 40)

  4. 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.

    Measured: At end of treatment (week 40)

  5. 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.

    Measured: At end of treatment (week 40)

  6. 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.

    Measured: At end of treatment (week 40)

  7. Number of Participants Achieving HbA1c Less Than (<) 7%

    Number of participants achieving HbA1c < 7% at the end of treatment (Week 40) were reported.

    Measured: At end of treatment (week 40)

  8. 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.

    Measured: From baseline (week 0) to end of treatment (week 40)

  9. 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.

    Measured: From baseline (week 0) to end of treatment (week 40)

  10. 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.

    Measured: From baseline (week 0) to end of treatment (week 40)

  11. 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.

    Measured: At end of treatment (week 40)

  12. 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.

    Measured: From baseline (week 0) to end of treatment (week 40)

  13. 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.

    Measured: From baseline (week 0) to end of treatment (week 40)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2022
  2. Study start29 Aug 2022
  3. Primary completion5 Mar 2025
  4. Study completion9 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
573 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05514535
Sponsor's protocol ID
NN9535-4801
Other IDs
U1111-1267-0312, 2021-004392-13
Status last verified
Apr 2026
First submitted
22 Aug 2022
Last updated
11 May 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Semaglutide, Insuline glargine U100 (reduced) and Insuline glargine U100 (titrated) in people with Diabetes Mellitus, Type 2 and Obesity, run by Novo Nordisk A/S at 239 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 239 sites in United States, Romania, Slovakia, Greece, Italy and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Glycated Haemoglobin (HbA1c) [Noninferiority] (time frame: From baseline (week 0) to end of treatment (week 40)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05514535.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.

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Clinical Trial NCT05514535 | AzTrials