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)

PHASE3CompletedINTERVENTIONAL
Enrollment

568

Participants

Timeline

Start Date

August 29, 2022

Primary Completion Date

March 5, 2025

Study Completion Date

April 9, 2025

Conditions
Diabetes Mellitus, Type 2Obesity
Interventions
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).

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).

Trial Locations (113)

1501

Diabetes Care Centre & CDE Centre, Benoni

East Rand Physicians, Benoni

East Rand Physicians, Johannesburg

2198

Centre for Diabetes, Johannesburg

4170

Dr T Padayachee, eMkhomazi

4450

Dr J Reddy, Durban

Dr Pillay's Rooms, Durban

11527

"Laiko General Hospital of Athens", Athens

11528

Alexandra General Hospital, Therapeutic Clinic, Athens

12203

Albany Medical College - Endo, Albany

12462

University Hospital of Athens ATTIKON, Athens

18100

ResTrial s.r.o., Prague

19107

Thomas Jefferson University, Philadelphia

20132

Istituto Scientifico San Raffaele, Milan

20852

Endo And Metab Cons, Rockville

24127

Azienda Ospedaliera Papa Giovanni XXIII, Bergamo

25018

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

28031

Hospital Infanta Leonor, Madrid

28557

Carteret Medical Group, Morehead City

Lucas Research Inc., Morehead City

31313

Coastal Heritage Clinical Research, Hinesville

32204

Northeast Res Inst. Inc., Jacksonville

32216

Jacksonville Ctr For Clin Res, Jacksonville

33024

Encore Medical Research LLC, Hollywood

33169

Elite Research Center, Miami

33175

Reyes Clinical Research, Inc, Miami

34470

Renstar Medical Research, Ocala

34652

Suncoast Clin Res Port Richey, New Port Richey

Suncoast Clinical Research, Inc._New Port Richey, New Port Richey

37660

Holston Medical Group, Kingsport

37938

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

41010

Hospital Infanta Luisa, Seville

43537

Advanced Med Res Maumee, Maumee

43614

University of Toledo Medical Center, Toledo

University of Toledo_Toledo, Toledo

44718

Diab & Endo Assoc of Stark Co, Canton

48098

Arcturus HC PLC Troy Med Res, Troy

49620

Northern Pines Hlth Ctr, PC, Buckley

50265

Iowa Diab & Endo Res Center, West Des Moines

50266

Iowa Diab & Endo Res Center, West Des Moines

54636

AHEPA General University Hospital, Thessaloniki

54645

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

55100

Ospedale Civile Campo di Marte, Lucca

57001

"Thermi Private Hosital", Thessaloniki

58104

Lillestol Research LLC, Fargo

59701

Mercury Str Med Grp, PLLC, Butte

60607

Cedar-Crosse Research Center, Chicago

66606

Cotton O'Neil Diab & Endo Ctr, Topeka

68100

University Hospital of Alexandroupolis, Alexandroupoli

70461

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

75208

Thyroid Endocrinology & Diabetes PA, Dallas

75230

Velocity Clinical Res-Dallas, Dallas

78229

Diabetes Glandular Diseases Clinic, San Antonio

78231

Consano Clinical Research, LLC, Shavano Park

78240

Diabetes Glandular Diseases Clinic, San Antonio

79106

Amarillo Med Spec LLP, Amarillo

80138

"A.O.U. Università Studi della Campania Luigi Vanvitelli", Napoli

"A.O.U. Università Studi della Campania Luigi Vanvitelli", Napoli

83103

MediTask, s.r.o, Bratislava

84117

Olympus Family Medicine, Salt Lake City

84790

Chrysalis Clinical Research, St. George

88100

Policlinico Mater Domini Università di Catanzaro, Catanzaro

89148

Palm Research Center Inc-Vegas, Las Vegas

90017

Velocity Clin Res Los Angeles, Los Angeles

91304

San Fernando Valley Hlth Inst, LLC, Canoga Park

91325

Valley Clinical Trials, Inc., Northridge

92120

Wetlin Research Associates, Inc., San Diego

92354

Loma Linda Univ Hlth Cr Endo, Loma Linda

93401

Diabetologicka ambulancia DIA-MAX s.r.o., Levice

93534

First Valley Medical Group, Lancaster

93720

Valley Research, Fresno

97201

DIA - CLARUS s.r.o., Bojnice

100018

Novus Medical Clinica SRL, Ploieşti

130083

Spitalul Judetean de Urgenta Targoviste, Târgovişte

300125

Centrul Medical Sfantul Stefan, Timișoara

410001

Medical Practice SRL, Oradea

410025

SC Grand Med SRL, Oradea

430222

CMI Dr Pop Lavinia, Baia Mare

440055

Clinica Korall S.R.L. Satu Mare, Satu Mare

500283

Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed, Brasov

700547

SC Consultmed SRL, Iași

900591

Clinic of Diabetes Constanta, Constanța

02215

Joslin Diabetes Center, Boston

03060

Southern New Hampshire Diabetes and Endocrinology, Nashua

76012-4637

Arlington Family Res. Ctr Inc, Arlington

547 01

EDUMED s.r.o. Nachod, Náchod

530 02

Diahelp - diabetologie, Pardubice

326 00

MUDr. Jitka Zemanova diabetologie a interna, Plzen - Vychodni Predmesti

110 00

Diabet2 s.r.o., Prague

140 00

MUDr. Michala Pelikanova, Prague

GR-11528

Alexandra General Hospital, Therapeutic Clinic, Athens

GR-18454

General Hospital of Nikaia, Nikaia

GR-57001

"Thermi Private Hosital", Thessaloniki

04100

Ospedale Santa Maria Goretti - UOD Diabetologia, Latina

06129

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

00168

Policlinico A. Gemelli, Rome

4464-513

Unidade Local De Saude De Matosinhos E.P.E., Senhora Da Hora, Matosinhos

2805-267

Unidade Local De Saude De Almada-Seixal E.P.E. - Hospital Garcia de Orta, Almada

4710-243

Unidade de Local de Saúde de Braga, Braga

2500-176

Unidade Local De Saude Do Oeste E.P.E., Caldas da Rainha

2410-197

Unidade Local De Saude Da Regiao De Leiria E.P.E.- Hospital de Santo André, Leiria

1050-099

Unidade Local de Saúde de São José EPE - Hospital Curry Cabral, Lisbon

1349-019

Unidade Local De Saude De Lisboa Ocidental E.P.E. - Hospital Egas Moniz, Lisbon

4904-858

Unidade Local de Saúde do Alto Minho E.P.E. - Viana do Castelo, Viana do Castelo

851 01

MEDISPEKTRUM s.r.o., Bratislava

984 01

IN-DIA s.r.o., Lučenec

940 59

FUNKYSTUFF s.r.o, Nové Zámky

05801

Diakom, spol. s r.o., Poprad

080 01

DIALIPID, s.r.o., Prešov

04801

Tatratrial s.r.o., Rožňava

943 01

BENROD s.r.o., Štúrovo

08430

ABS La Roca del Vallés, La Roca Del Vallés

07120

Hospital Son Espases, Palma de Mallorca

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novo Nordisk A/S

INDUSTRY