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)
NCT ID: NCT05514535
Last Updated: 2025-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
568 participants
INTERVENTIONAL
2022-08-29
2025-04-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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)).
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.
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).
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).
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).
Interventions
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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.
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).
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).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Transparency (dept. 2834)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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MediTask, s.r.o
Bratislava, , Slovakia
MEDISPEKTRUM s.r.o.
Bratislava, , Slovakia
Diabetologicka ambulancia DIA-MAX s.r.o.
Levice, , Slovakia
IN-DIA s.r.o.
Lučenec, , Slovakia
FUNKYSTUFF s.r.o
Nové Zámky, , Slovakia
Diakom, spol. s r.o.
Poprad, , Slovakia
DIALIPID, s.r.o.
Prešov, , Slovakia
Tatratrial s.r.o.
Rožňava, , Slovakia
BENROD s.r.o.
Štúrovo, , Slovakia
Diabetes Care Centre & CDE Centre
Benoni, Gauteng, South Africa
East Rand Physicians
Benoni, Gauteng, South Africa
East Rand Physicians
Johannesburg, Gauteng, South Africa
Centre for Diabetes
Johannesburg, Gauteng, South Africa
Dr J Reddy
Durban, KwaZulu-Natal, South Africa
Dr Pillay's Rooms
Durban, KwaZulu-Natal, South Africa
Dr T Padayachee
eMkhomazi, KwaZulu-Natal, South Africa
Centro Periférico de Especialidades Bola Azul
Almería, , Spain
ABS La Roca del Vallés_Endocrinología
La Roca Del Vallés, , Spain
ABS La Roca del Vallés
La Roca Del Vallés, , Spain
Hospital Infanta Leonor
Madrid, , Spain
Hospital Son Espases
Palma de Mallorca, , Spain
Hospital Infanta Luisa
Seville, , Spain
Kharkiv Regional Clinical Hospital - Endocrinology department
Kharkiv, , Ukraine
Khmelnytskyi Regional Hospital - Endocrinology department
Khmelnytskyi, , Ukraine
Ternopil Central District Hospital - Outpatient department
Ternopil, , Ukraine
Medical centre"Elitmedservis"LLC
Zaporizhzhia, , Ukraine
Lenzmeier Fam Med CCT Research
Glendale, Arizona, United States
San Fernando Valley Hlth Inst, LLC
Canoga Park, California, United States
John Muir Physicians Network
Concord, California, United States
Valley Research
Fresno, California, United States
Providence Medical Foundation
Fullerton, California, United States
Velocity Clinical Research Huntington Park
Huntington Park, California, United States
Velocity Clin Res San Diego
La Mesa, California, United States
First Valley Medical Group
Lancaster, California, United States
Loma Linda Univ Hlth Cr Endo
Loma Linda, California, United States
Downtown LA Res Ctr. Inc.
Los Angeles, California, United States
Velocity Clin Res Los Angeles
Los Angeles, California, United States
Valley Clinical Trials, Inc.
Northridge, California, United States
Wetlin Research Associates, Inc.
San Diego, California, United States
Encore Medical Research LLC
Hollywood, Florida, United States
Northeast Res Inst. Inc.
Jacksonville, Florida, United States
Jacksonville Ctr For Clin Res
Jacksonville, Florida, United States
New Horizon Research Center
Miami, Florida, United States
Elite Research Center
Miami, Florida, United States
Reyes Clinical Research, Inc
Miami, Florida, United States
International Research Associates, LLC_Miami
Miami, Florida, United States
Suncoast Clin Res Port Richey
New Port Richey, Florida, United States
Suncoast Clinical Research, Inc._New Port Richey
New Port Richey, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
CVS Store Number: 7689
Atlanta, Georgia, United States
Coastal Heritage Clinical Research
Hinesville, Georgia, United States
Endocrine Research Solutions
Roswell, Georgia, United States
CVS Store Number: 05520
Savannah, Georgia, United States
Cedar-Crosse Research Center
Chicago, Illinois, United States
Brengle Family Medicine
Indianapolis, Indiana, United States
West Broadway Clinic
Council Bluffs, Iowa, United States
Iowa Diab & Endo Res Center
West Des Moines, Iowa, United States
Iowa Diab & Endo Res Center
West Des Moines, Iowa, United States
Cotton O'Neil Diab & Endo Ctr
Topeka, Kansas, United States
The Research Group of Lexington LLC
Lexington, Kentucky, United States
AMR New Orleans
New Orleans, Louisiana, United States
Ileana J. Tandron, MD APMC (a private medical office)
Slidell, Louisiana, United States
MedStar Hlth Res Institute
Hyattsville, Maryland, United States
Endo And Metab Cons
Rockville, Maryland, United States
Joslin Diabetes Center
Boston, Massachusetts, United States
Northern Pines Hlth Ctr, PC
Buckley, Michigan, United States
Elite Research Center
Flint, Michigan, United States
Arcturus HC PLC Troy Med Res
Troy, Michigan, United States
StudyMetrix Research LLC
City of Saint Peters, Missouri, United States
Mercury Str Med Grp, PLLC
Butte, Montana, United States
Palm Research Center Inc-Vegas
Las Vegas, Nevada, United States
Southern New Hampshire Diabetes and Endocrinology
Nashua, New Hampshire, United States
AMC Community Endocrinology
Albany, New York, United States
Mid Hudson Med Res-New Windsor
New Windsor, New York, United States
Carteret Medical Group
Morehead City, North Carolina, United States
Lucas Research Inc.
Morehead City, North Carolina, United States
Lillestol Research LLC
Fargo, North Dakota, United States
Velocity Clin Res Cleveland
Beachwood, Ohio, United States
Diab & Endo Assoc of Stark Co
Canton, Ohio, United States
Advanced Med Res Maumee
Maumee, Ohio, United States
University of Toledo Medical Center
Toledo, Ohio, United States
University of Toledo_Toledo
Toledo, Ohio, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Chattanooga Medical Research, LLC
Chattanooga, Tennessee, United States
Holston Medical Group
Kingsport, Tennessee, United States
Accellacare US Inc., d/b/a Accellacare of Knoxville
Knoxville, Tennessee, United States
Amarillo Med Spec LLP
Amarillo, Texas, United States
Arlington Family Res. Ctr Inc
Arlington, Texas, United States
Thyroid Endocrinology & Diabetes PA
Dallas, Texas, United States
Velocity Clinical Res-Dallas
Dallas, Texas, United States
Diabetes and Thyroid Ctr of FW
Fort Worth, Texas, United States
San Antonio Prem Int Med
San Antonio, Texas, United States
Diabetes Glandular Diseases Clinic
San Antonio, Texas, United States
VIP Trials
San Antonio, Texas, United States
Diabetes Glandular Diseases Clinic
San Antonio, Texas, United States
Consano Clinical Research, LLC
Shavano Park, Texas, United States
Hillcrest Family Health Center
Waco, Texas, United States
Olympus Family Medicine
Salt Lake City, Utah, United States
Chrysalis Clinical Research
St. George, Utah, United States
Virginia Endo Res, LLC
Chesapeake, Virginia, United States
CVS Store Number: 01396
Reston, Virginia, United States
CVS Store Number: 1537
Richmond, Virginia, United States
Amherst Family Practice P.C.
Winchester, Virginia, United States
WVU Medicine
Morgantown, West Virginia, United States
EDUMED s.r.o.
Náchod, , Czechia
Diahelp - diabetologie
Pardubice, , Czechia
MUDr. Jitka Zemanova - diabetologie a interna, s.r.o.
Plzen - Vychodni Predmesti, , Czechia
Diabet2 s.r.o.
Prague, , Czechia
MUDr. Michala Pelikanova
Prague, , Czechia
ResTrial s.r.o.
Prague, , Czechia
University Hospital of Athens ATTIKON
Athens, Attica, Greece
University Hospital of Alexandroupolis
Alexandroupoli, , Greece
"Laiko" General Hospital of Athens
Athens, , Greece
Alexandra General Hospital, Therapeutic Clinic
Athens, , Greece
Alexandra General Hospital, Therapeutic Clinic
Athens, , Greece
General Hospital of Nikaia
Nikaia, , Greece
Tzaneio General Hospital of Piraeus
Piraeus, , Greece
AHEPA General University Hospital
Thessaloniki, , Greece
EUROMEDICA Gen Clinic The/ki, Endocrin,Metabolism,Diabetes
Thessaloniki, , Greece
"Thermi" Private Hosital
Thessaloniki, , Greece
General Hospital of Thessaloniki "G.Papanikolaou"
Thessaloniki, , Greece
"Thermi" Private Hosital
Thessaloniki, , Greece
A.O.U. Università Studi della Campania "Luigi Vanvitelli"
Napoli, Campania, Italy
Ospedale Santa Maria Goretti - UOD Diabetologia
Latina, LT, Italy
Azienda Unita' Sanitaria Locale Toscana Nord Ovest - Cittadella della Salute Campo di Marte
Lucca, LU, Italy
Istituto Scientifico San Raffaele
Milan, MI, Italy
Azienda Ospedaliera di Perugia;Ospedale S. Maria della Misericordia
Perugia, Umbria, Italy
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, , Italy
Policlinico Mater Domini Università di Catanzaro
Catanzaro, , Italy
ASST degli Spedali Civili di Brescia-Presidio Ospedaliero di Montichiari
Montichiari, , Italy
A.O.U. Università Studi della Campania "Luigi Vanvitelli"
Napoli, , Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Dipartimento di scienze Mediche e Chirurgiche
Rome, , Italy
Unidade Local De Saude De Matosinhos E.P.E.
Senhora Da Hora, Matosinhos, Matosinhos, Portugal
Unidade Local De Saude De Almada-Seixal E.P.E. - Hospital Garcia de Orta
Almada, , Portugal
Unidade Local De Saude Da Regiao De Aveiro E.P.E.
Aveiro, , Portugal
Unidade de Local de Saúde de Braga
Braga, , Portugal
Unidade Local De Saude Do Oeste E.P.E.
Caldas da Rainha, , Portugal
Unidade Local De Saude Da Regiao De Leiria E.P.E.- Hospital de Santo André
Leiria, , Portugal
Unidade Local de Saúde de São José EPE - Hospital Curry Cabral
Lisbon, , Portugal
Unidade Local De Saude De Lisboa Ocidental E.P.E. - Hospital Egas Moniz
Lisbon, , Portugal
Unidade Local de Saúde do Alto Minho E.P.E. - Viana do Castelo
Viana do Castelo, , Portugal
SC Grand Med SRL
Oradea, Bihor County, Romania
Spitalul Judetean de Urgenta Targoviste
Târgovişte, Dâmbovița County, Romania
CMI Dr Pop Lavinia
Baia Mare, Maramureş, Romania
Novus Medical Clinica SRL
Ploieşti, Prahova, Romania
Centrul Medical Sfantul Stefan
Timișoara, Timiș County, Romania
Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed
Brasov, , Romania
Clinica Grivitei 224 S.R.L.
Brăila, , Romania
Diabs&Nutricare Srl
Bucharest, , Romania
Clinic of Diabetes Constanta
Constanța, , Romania
Clinical Emergency Sf. Apostol Andrei Hospital
Galati, , Romania
SC Consultmed SRL
Iași, , Romania
Medical Practice SRL
Oradea, , Romania
S.C. Dianutrilife Medica S.R.L.
Ploieşti, , Romania
Clinica Korall S.R.L. Satu Mare
Satu Mare, , Romania
Dentosim Queen Srl
Târgu Mureş, , Romania
DIA - CLARUS s.r.o.
Bojnice, , Slovakia
Countries
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Other Identifiers
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U1111-1267-0312
Identifier Type: OTHER
Identifier Source: secondary_id
2021-004392-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NN9535-4801
Identifier Type: -
Identifier Source: org_study_id
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