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
3 other identifiers
interventional
573
12 countries
239
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 diabetes-mellitus-type-2
Started Aug 2022
Longer than P75 for phase_3 diabetes-mellitus-type-2
239 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 22, 2022
CompletedFirst Posted
Study publicly available on registry
August 24, 2022
CompletedStudy Start
First participant enrolled
August 29, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 5, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 9, 2025
CompletedResults Posted
Study results publicly available
May 11, 2026
CompletedMay 11, 2026
April 1, 2026
2.5 years
August 22, 2022
March 5, 2026
April 17, 2026
Conditions
Outcome Measures
Primary Outcomes (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.
From baseline (week 0) to end of treatment (week 40)
Secondary Outcomes (13)
Change in Body Weight
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)
Change in Glycated Haemoglobin (HbA1c ) [Superiority]
From baseline (week 0) to end of treatment (week 40)
Score of Diabetes Treatment Satisfaction Questionnaire - Change Version (DTSQc)
At end of treatment (week 40)
Number of Participants Achieving Insulin Dose = 0 Units/mL (U)
At end of treatment (week 40)
- +8 more secondary outcomes
Study Arms (2)
Insuline glargine U100 (reduced) + semaglutide
EXPERIMENTALParticipants 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)).
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).
Interventions
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).
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.
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).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (239)
Shoals Primary Care
Sheffield, Alabama, 35660, United States
Lenzmeier Fam Med CCT Research
Glendale, Arizona, 85308, United States
Synexus Clinical Research US, Inc./Desert Clinical Research,
Mesa, Arizona, 85213, United States
OneLife Direct Care Inc.
Searcy, Arkansas, 72143, United States
Unity Health-Searcy Medical Center
Searcy, Arkansas, 72143, United States
San Fernando Valley Hlth Inst, LLC
Canoga Park, California, 91304, United States
Velocity Clin Res-Chula Vista
Chula Vista, California, 91911, United States
John Muir Physicians Network
Concord, California, 94520, United States
Valley Research
Fresno, California, 93720, United States
Ascada Research
Fullerton, California, 92835, United States
Providence Medical Foundation
Fullerton, California, 92835, United States
Velocity Clinical Research Huntington Park
Huntington Park, California, 90255, United States
Scripps Memorial Hospital La Jolla
La Jolla, California, 92037, United States
Velocity Clin Res San Diego
La Mesa, California, 91942, United States
First Valley Medical Group
Lancaster, California, 93534, United States
Loma Linda Univ Hlth Cr Endo
Loma Linda, California, 92354, United States
Torrance Clin Res Inst, Inc.
Lomita, California, 90717, United States
NRC Research Institute
Los Angeles, California, 90015, United States
Downtown LA Res Ctr. Inc.
Los Angeles, California, 90017, United States
Velocity Clin Res Los Angeles
Los Angeles, California, 90017, United States
Valley Clinical Trials, Inc.
Northridge, California, 91325, United States
San Diego Family Care_San Diego
San Diego, California, 92111, United States
Wetlin Research Associates, Inc.
San Diego, California, 92120, United States
University Clin Investigators
Tustin, California, 92780, United States
Velocity Clin Res, Denver
Denver, Colorado, 80209, United States
Chase Medical Research LLC
Waterbury, Connecticut, 06708, United States
Indago Research & Health Center Inc.
Hialeah, Florida, 33012, United States
Encore Medical Research LLC
Hollywood, Florida, 33024, United States
Northeast Res Inst. Inc.
Jacksonville, Florida, 32204, United States
Jacksonville Ctr For Clin Res
Jacksonville, Florida, 32216, United States
Care-Partners-Clinical-Research, LLC
Jacksonville, Florida, 32277, United States
Suncoast Research Group, LLC
Miami, Florida, 33135, United States
New Horizon Research Center
Miami, Florida, 33165, United States
Elite Research Center
Miami, Florida, 33169, United States
Diverse Clinical Research Miami
Miami, Florida, 33175, United States
Reyes Clinical Research, Inc
Miami, Florida, 33175, United States
International Research Associates, LLC_Miami
Miami, Florida, 33183, United States
South Broward Research LLC
Miramar, Florida, 33027, United States
Suncoast Clin Res Port Richey
New Port Richey, Florida, 34652, United States
Suncoast Clinical Research, Inc._New Port Richey
New Port Richey, Florida, 34652, United States
Renstar Medical Research
Ocala, Florida, 34470, United States
Clinical Research Trials of Florida
Tampa, Florida, 33607, United States
CVS Store Number: 7689
Atlanta, Georgia, 30329-4015, United States
East Coast Institute for Res
Canton, Georgia, 30114, United States
Coastal Heritage Clinical Research
Hinesville, Georgia, 31313, United States
East Coast Institute for Res
Macon, Georgia, 31210, United States
Endocrine Research Solutions
Roswell, Georgia, 30076, United States
CVS Store Number: 05520
Savannah, Georgia, 31405-6901, United States
Solaris Clinical Research
Meridian, Idaho, 83646, United States
Cedar-Crosse Research Center
Chicago, Illinois, 60607, United States
WellNow Urgent Care
Chicago, Illinois, 60661, United States
Brengle Family Medicine
Indianapolis, Indiana, 46260, United States
West Broadway Clinic
Council Bluffs, Iowa, 51501, United States
Iowa Diab & Endo Res Center
West Des Moines, Iowa, 50265, United States
Iowa Diab & Endo Res Center
West Des Moines, Iowa, 50266, United States
Cotton O'Neil Diab & Endo Ctr
Topeka, Kansas, 66606, United States
The Research Group of Lexington LLC
Lexington, Kentucky, 40503, United States
L-MARC Research Center
Louisville, Kentucky, 40213, United States
Arthritis And Diabetes Clinic, Inc.
Monroe, Louisiana, 71203, United States
AMR New Orleans
New Orleans, Louisiana, 70119, United States
Ileana J. Tandron, MD APMC (a private medical office)
Slidell, Louisiana, 70461, United States
MedStar Hlth Res Institute
Hyattsville, Maryland, 20782, United States
Endo And Metab Cons
Rockville, Maryland, 20852, United States
Brigham & Women's Hospital
Boston, Massachusetts, 02115, United States
Joslin Diabetes Center
Boston, Massachusetts, 02215, United States
Northern Pines Hlth Ctr, PC
Buckley, Michigan, 49620, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Elite Research Center
Flint, Michigan, 48532, United States
Arcturus HC PLC Troy Med Res
Troy, Michigan, 48098, United States
StudyMetrix Research LLC
City of Saint Peters, Missouri, 63303, United States
Mercury Str Med Grp, PLLC
Butte, Montana, 59701, United States
Clinical Research Advantage, Inc./Skyline Medical Center, PC
Elkhorn, Nebraska, 68022, United States
Methodist Physicians Clinic
Fremont, Nebraska, 68025, United States
Velocity Clin Res, Norfolk
Norfolk, Nebraska, 68701, United States
Midwest Regional Health Services
Omaha, Nebraska, 68144, United States
Univ of Nebraska Medical CTR
Omaha, Nebraska, 68198-3020, United States
Palm Research Center Inc-Vegas
Las Vegas, Nevada, 89128, United States
Southern New Hampshire Diabetes and Endocrinology
Nashua, New Hampshire, 03060, United States
Premier Research Inc.
Trenton, New Jersey, 08611, United States
AMC Community Endocrinology
Albany, New York, 12203, United States
Dr. Alexander Perkelvald
Brooklyn, New York, 11229, United States
Mid Hudson Med Res-New Windsor
New Windsor, New York, 12553, United States
Great Lakes Medical Research
Westfield, New York, 14787, United States
University of North Carolina Medical Center
Chapel Hill, North Carolina, 27514, United States
Physicians East Endocrinology
Greenville, North Carolina, 27834, United States
Carteret Medical Group
Morehead City, North Carolina, 28557, United States
Centricity Rsrch MHCity Multi
Morehead City, North Carolina, 28557, United States
Lillestol Research LLC
Fargo, North Dakota, 58104, United States
Velocity Clin Res Cleveland
Beachwood, Ohio, 44122, United States
Diab & Endo Assoc of Stark Co
Canton, Ohio, 44718, United States
Velocity Clin Res_Cincinnati
Cincinnati, Ohio, 45219, United States
Albert J Weisbrot
Mason, Ohio, 45040, United States
Advanced Med Res Maumee
Maumee, Ohio, 43537, United States
University of Toledo Medical Center
Toledo, Ohio, 43614, United States
University of Toledo_Toledo
Toledo, Ohio, 43614, United States
Intend Research
Norman, Oklahoma, 73069, United States
Lynn Institute of Norman
Norman, Oklahoma, 73069, United States
Velocity Clinical Res Medford
Medford, Oregon, 97504, United States
Heritage Valley Multispeciality Group Inc
Beaver, Pennsylvania, 15009, United States
Richard M Kastelic MD Assoc
Johnstown, Pennsylvania, 15905, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Preferred Primary Care Physicians, Inc.
Uniontown, Pennsylvania, 15401, United States
Carolina Health Specialists
Myrtle Beach, South Carolina, 29572, United States
Palmetto Clinical Research
Summerville, South Carolina, 29485, United States
Chattanooga Medical Research, LLC
Chattanooga, Tennessee, 37404, United States
Univ Diab & Endo Consultants
Chattanooga, Tennessee, 37411, United States
Jackson Clinic
Jackson, Tennessee, 38305, United States
Holston Medical Group
Kingsport, Tennessee, 37660, United States
Accellacare US Inc., d/b/a Accellacare of Knoxville
Knoxville, Tennessee, 37938, United States
Clinical Neuroscience Solutions
Memphis, Tennessee, 38119, United States
Amarillo Med Spec LLP
Amarillo, Texas, 79106, United States
Arlington Family Res. Ctr Inc
Arlington, Texas, 76012-4637, United States
Central Texas Clinical Research
Austin, Texas, 78705, United States
Velocity Clin Res Austin
Cedar Park, Texas, 78613, United States
Thyroid Endocrinology & Diabetes PA
Dallas, Texas, 75208, United States
Velocity Clinical Res-Dallas
Dallas, Texas, 75230, United States
Academy of Diabetes, T&E
El Paso, Texas, 79935, United States
Diabetes and Thyroid Ctr of FW
Fort Worth, Texas, 76132, United States
Gonzalez Family & Occupational Medicine
Houston, Texas, 77029, United States
JCCT- Juno NW Houston
Houston, Texas, 77040, United States
Houston Institute for Clinical Research
Houston, Texas, 77074, United States
Protenium Clinical Research
Hurst, Texas, 76054, United States
DCOL Ctr for Clin Res
Longview, Texas, 75605, United States
Tekton Research
McKinney, Texas, 75069, United States
Clinical Investigations Of Texas
Plano, Texas, 75075, United States
San Antonio Prem Int Med
San Antonio, Texas, 78220, United States
Briggs Clinical Research, LLC
San Antonio, Texas, 78224, United States
Diabetes Glandular Diseases Clinic
San Antonio, Texas, 78229, United States
VIP Trials
San Antonio, Texas, 78230, United States
Diabetes Glandular Diseases Clinic
San Antonio, Texas, 78240, United States
Consano Clinical Research, LLC
Shavano Park, Texas, 78231, United States
Med-Olam Clinical Reseach LLC
Sugar Land, Texas, 77479, United States
Hillcrest Family Health Center
Waco, Texas, 76708, United States
Advanced Research Institute
Ogden, Utah, 84405, United States
South Ogden Family Medicine/ CCT Research
Ogden, Utah, 84405, United States
Olympus Family Medicine
Salt Lake City, Utah, 84117, United States
Chrysalis Clinical Research
St. George, Utah, 84790, United States
Velocity Clin Res-Salt Lk City
West Jordan, Utah, 84088, United States
Virginia Endo Res, LLC
Chesapeake, Virginia, 23321, United States
York Clinical Research LLC
Norfolk, Virginia, 23504, United States
CVS Store Number: 01396
Reston, Virginia, 20191-4327, United States
CVS Store Number: 1537
Richmond, Virginia, 23230-3005, United States
Amherst Family Practice P.C.
Winchester, Virginia, 22601, United States
WVU Medicine
Morgantown, West Virginia, 26506, United States
Prevea Health
Green Bay, Wisconsin, 54303, United States
EDUMED s.r.o.
Náchod, 547 01, Czechia
Diahelp - diabetologie
Pardubice, 530 02, Czechia
MUDr. Jitka Zemanova - diabetologie a interna, s.r.o.
Plzen - Vychodni Predmesti, 326 00, Czechia
Diabet2 s.r.o.
Prague, 110 00, Czechia
MUDr. Michala Pelikanova
Prague, 140 00, Czechia
ResTrial s.r.o.
Prague, 18100, Czechia
University Hospital of Athens ATTIKON
Athens, Attica, 12462, Greece
University Hospital of Alexandroupolis
Alexandroupoli, 68100, Greece
"Laiko" General Hospital of Athens
Athens, 11527, Greece
Alexandra General Hospital, Therapeutic Clinic
Athens, 11528, Greece
Alexandra General Hospital, Therapeutic Clinic
Athens, GR-11528, Greece
Geniko Nosokomeio Nikaias Peiraia Ag. Panteleimon Geniko Nosokomeio Dytikis Attikis I - Diabetes Department
Nikaia, GR-18454, Greece
Geniko Nosokomeio Peiraia Tzaneio
Piraeus, 18536, Greece
AHEPA General University Hospital
Thessaloniki, 54636, Greece
EUROMEDICA Gen Clinic The/ki, Endocrin,Metabolism,Diabetes
Thessaloniki, 54645, Greece
"Thermi" Private Hosital
Thessaloniki, 57001, Greece
General Hospital of Thessaloniki "G.Papanikolaou"
Thessaloniki, 57010, Greece
"Thermi" Private Hosital
Thessaloniki, GR-57001, Greece
A.O.U. Università Studi della Campania "Luigi Vanvitelli"
Naples, Campania, 80138, Italy
Ospedale Santa Maria Goretti - UOD Diabetologia
Latina, LT, 04100, Italy
Azienda Unita' Sanitaria Locale Toscana Nord Ovest - Cittadella della Salute Campo di Marte
Lucca, LU, 55100, Italy
Istituto Scientifico San Raffaele
Milan, MI, 20132, Italy
Policlinico Umberto I Seconda Clinica Medica
Roma, RM, 00161, Italy
Azienda Ospedaliera di Perugia;Ospedale S. Maria della Misericordia
Perugia, Umbria, 06129, Italy
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, 24127, Italy
Policlinico Mater Domini Università di Catanzaro
Catanzaro, 88100, Italy
ASST degli Spedali Civili di Brescia-Presidio Ospedaliero di Montichiari
Montichiari, 25018, Italy
A.O.U. Università Studi della Campania "Luigi Vanvitelli"
Naples, 80138, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Dipartimento di scienze Mediche e Chirurgiche
Rome, 00168, Italy
ULS De Matosinhos E.P.E.- Hospital Pedro Hispano
Senhora Da Hora, Matosinhos, Matosinhos, 4464-513, Portugal
ULS De Almada-Seixal E.P.E. - Hospital Garcia de Orta
Almada, 2805-267, Portugal
ULS Da Regiao De Aveiro E.P.E. - Hospital Infante D. Pedro
Aveiro, 3814-501, Portugal
ULS De Braga, E.P.E. - Hospital de Braga
Braga, 4710-243, Portugal
ULS Do Oeste E.P.E. - Unidade Caldas da Rainha
Caldas da Rainha, 2500-176, Portugal
ULS Da Região De Leiria E.P.E.- Hospital de Santo André
Leiria, 2410-197, Portugal
Unidade Local De Saúde De São José, E.P.E. - Hospital Curry Cabral
Lisbon, 1050-099, Portugal
Unidade Local De Saúde De Lisboa Ocidental E.P.E. - Hospital Egas Moniz
Lisbon, 1349-019, Portugal
ULS De Santo António, E.P.E. - Hospital de Santo António
Porto, 4099-001, Portugal
ULS De São João, E.P.E. - Hospital de São João
Porto, 4200-319, Portugal
ULS Do Alto Minho E.P.E. - Hospital de Santa Luzia
Viana do Castelo, 4904-858, Portugal
Caribbean Medical Research Center
San Juan, 00918, Puerto Rico
Medical Practice SRL
Oradea, Bihor County, 410001, Romania
Grandmed SRL
Oradea, Bihor County, 410159, Romania
Spitalul Judetean de Urgenta Targoviste
Targoviste, Dâmbovița County, 130083, Romania
CMI Dr Pop Lavinia
Baia Mare, Maramureş, 430222, Romania
Novus Medical Clinica SRL
Ploieşti, Prahova, 100018, Romania
Centrul Medical Sfantul Stefan
Timișoara, Timiș County, 300125, Romania
Mariodiab Clinic SRL
Brasov, 500101, Romania
Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed
Brasov, 500283, Romania
Clinica Grivitei 224 S.R.L.
Brăila, 810197, Romania
Diabs&Nutricare Srl
Bucharest, 040172, Romania
Clinic of Diabetes Constanta
Constanța, 900591, Romania
Clinical Emergency Sf. Apostol Andrei Hospital
Galati, 800578, Romania
SC Consultmed SRL
Iași, 700547, Romania
S.C. Dianutrilife Medica S.R.L.
Ploieşti, 100561, Romania
Clinica Korall S.R.L. Satu Mare
Satu Mare, 440055, Romania
Dentosim Queen Srl
Târgu Mureş, 540098, Romania
Volosevich First City Clinical Hospital
Arkhangelsk, 163001, Russia
SPb SBHI "Snegirev Maternity Hospital No. 6"
Saint Petersburg, 191014, Russia
Medinet LLC
Saint Petersburg, 194356, Russia
SPb SBHI City polyclinic #117
Saint Petersburg, 194358, Russia
Medical Research Institute LLC
Saint Petersburg, 196084, Russia
Solovyev Clinical Emergency Hospital
Yaroslavl, 150003, Russia
Solovyov Clinical Emergency Hospital
Yaroslavl, 150003, Russia
DIA - CLARUS s.r.o.
Bojnice, 97201, Slovakia
MediTask, s.r.o
Bratislava, 83103, Slovakia
MEDISPEKTRUM s.r.o.
Bratislava, 851 01, Slovakia
DIA-MAX s.r.o.
Levice, 93401, Slovakia
IN-DIA s.r.o.
Lučenec, 984 01, Slovakia
DIA - SANTMART, s.r.o., Ambulancia diabetologie a poruch latkovej premeny a vyzivy
Martin, 036 01, Slovakia
FUNKYSTUFF s.r.o
Nové Zámky, 940 59, Slovakia
Diakom, spol. s r.o.
Poprad, 05801, Slovakia
DIALIPID, s.r.o.
Prešov, 080 01, Slovakia
Tatratrial s.r.o.
Rožňava, 04801, Slovakia
Amb. Diabetologie a prouch latkovej premeny a vyzivy ENDIANT s.r.o.
Sereď, 926 01, Slovakia
BENROD s.r.o.
Štúrovo, 943 01, Slovakia
MUDr. Korecova, metabolicke centrum s.r.o.
Trenčín, 911 01, Slovakia
Diabetes Care Centre & CDE Centre
Benoni, Gauteng, 1501, South Africa
East Rand Physicians
Benoni, Gauteng, 1501, South Africa
East Rand Physicians
Johannesburg, Gauteng, 1501, South Africa
Centre for Diabetes
Johannesburg, Gauteng, 2198, South Africa
Dr J Reddy
Durban, KwaZulu-Natal, 4450, South Africa
Dr Pillay's Rooms
Durban, KwaZulu-Natal, 4450, South Africa
Dr T Padayachee
eMkhomazi, KwaZulu-Natal, 4170, South Africa
Centro Periférico de Especialidades Bola Azul
Almería, 04009, Spain
ABS La Roca del Vallés_Endocrinología
La Roca Del Vallés, 08430, Spain
ABS La Roca del Vallés
La Roca Del Vallés, 08430, Spain
Hospital Infanta Leonor
Madrid, 28031, Spain
Hospital Son Espases
Palma de Mallorca, 07120, Spain
H. Infanta Luisa_Endocrino y Obesidad
Seville, 41010, Spain
Kharkiv Regional Clinical Hospital - Endocrinology department
Kharkiv, 61058, Ukraine
Khmelnytskyi Regional Hospital - Endocrinology department
Khmelnytskyi, 29000, Ukraine
Ternopil Central District Hospital - Outpatient department
Ternopil, 46001, Ukraine
Medical centre"Elitmedservis"LLC
Zaporizhzhia, 69037, Ukraine
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Reporting Office (2834)
- Organization
- Novo Nordisk A/S
Study Officials
- STUDY DIRECTOR
Clinical Transparency (dept. 2834)
Novo Nordisk A/S
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 22, 2022
First Posted
August 24, 2022
Study Start
August 29, 2022
Primary Completion
March 5, 2025
Study Completion
April 9, 2025
Last Updated
May 11, 2026
Results First Posted
May 11, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com