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AzTrials

Diabetes Mellitus, Type 1Phase 3ONWARDS 11NCT07076199

A Research Study to See How a Weekly Insulin, Insulin Icodec, Helps in Reducing the Blood Sugar Compared to Daily Insulin Glargine, Both in Combination With Insulin Aspart, in Adults With Type 1 Diabetes

A Phase 3 study testing Insulin icodec, Insulin glargine and Insulin aspart in people with Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 182 sites in 8 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This study compares insulin icodec, an insulin taken once a week to insulin glargine, an insulin taken once a day. The study medicine will be investigated in participants with type 1 diabetes. The study will look at how well insulin icodec taken weekly controls blood sugar compared to insulin glargine taken daily. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Type 1
What is being tested?
Insulin icodec, Insulin glargine and Insulin aspart
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
877 participants
Where
182 sitesin 8 countries
Study dates
11 Aug 2025to 1 Mar 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 1 diabetes mellitus greater than or equal to (≥) 1 year before screening.
  • Treated with multiple daily insulin injections (daily basal insulin analogue and bolus insulin analogue regimen) ≥ 6 months before screening.
  • HbA1c from 7.0-10.0 percentage (%) (53.0-85.8 millimoles per mole (mmol/mol)), both inclusive, at screening confirmed by central laboratory analysis.
  • Ability and willingness to adhere to the protocol including performance of self-measured plasma glucose (SMPG) profiles, based on the investigator's judgement.

Who cannot join

  • Known or suspected hypersensitivity to study intervention(s) or related products.
  • Previous participation in this study. Participation is defined as signed informed consent.
  • Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method.
  • Exposure to an investigational medicinal product within 90 days or 5 half-lives of the investigational medicinal product (if known), whichever is longer, before screening.
  • Any condition, except for conditions associated with type 1 diabetes mellitus, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
  • Anticipated initiation or anticipated change in concomitant medications (for more than 15 consecutive days) known to affect weight or glucose metabolism (e.g., treatment with thyroid hormones, or systemic corticosteroids).
  • Known hypoglycaemic unawareness as indicated by the Investigator according to Clarke's questionnaire question.
  • Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator.

Trial locations and contacts

182 sites in 8 countries.

182 sites in 8 countries

United States103 sites
  • AMC Community Endocrinology

    Albany, New York, 12203

  • Albuquerque Clinical Trials Inc.

    Albuquerque, New Mexico, 87102

  • Amarillo Medical Specialists

    Amarillo, Texas, 79124

  • Atlanta Diabetes Associates

    Atlanta, Georgia, 30318

  • Texas Diab Endo ATX N Mopac EXPR

    Austin, Texas, 78731

  • Texas Diabetes & Endocrinology

    Austin, Texas, 78749

  • Brigham & Women's Hospital

    Boston, Massachusetts, 02115-5804

  • Holston Medical Group_Bristol

    Bristol, Tennessee, 37620

  • Diab & Endo Assoc of Stark Co

    Canton, Ohio, 44718

  • University Diabetes & Endocrine Consultants

    Chattanooga, Tennessee, 37411

  • Northwestern University

    Chicago, Illinois, 60611

  • University Of Chicago

    Chicago, Illinois, 60637-1447

  • Profound Research LLC

    Clarkston, Michigan, 48346

  • Cleveland Clinic_Cleveland

    Cleveland, Ohio, 44195

  • Centricity Research Columbus

    Columbus, Georgia, 31904

  • The Ohio State University Medical Center

    Columbus, Ohio, 43203

  • John Muir Health

    Concord, California, 94520

  • Cullman Clinical Trials

    Cullman, Alabama, 35055

  • Alliance Clinical Network

    Dallas, Texas, 75203

  • Thyroid Endocrinology & Diabetes PA

    Dallas, Texas, 75208

  • Velocity Clinical Res-Dallas

    Dallas, Texas, 75230

  • North Texas Endocrine Center

    Dallas, Texas, 75231

  • Research Institute Of Dallas

    Dallas, Texas, 75231

  • Precision Endo - Revival

    Denton, Texas, 76210

  • Epic Medical Research

    DeSoto, Texas, 75115

  • Frontier Medical Ctr

    El Paso, Texas, 79935

  • Denver Endocrinology Diabetes and Thyroid Center

    Englewood, Colorado, 80113

  • Headlands Research California, LLC

    Escondido, California, 92025

  • Profound Research LLC

    Farmington Hills, Michigan, 48334

  • Northeast Research Institute

    Fleming Island, Florida, 32003

  • Elite Clinical Research Center

    Flint, Michigan, 48532

  • N. Texas Diab & Endo - Prime

    Flower Mound, Texas, 75028

  • Diabetes and Thyroid Center of Fort Worth

    Fort Worth, Texas, 76132

  • Clinical Res of Central Ca

    Fresno, California, 93704

  • Providence Medical Foundation

    Fullerton, California, 92835

  • Optumcare Clinical Trials,LLC-Golden

    Golden, Colorado, 80401

  • Prevea Health

    Green Bay, Wisconsin, 54303

  • Physicians East Endocrinology

    Greenville, North Carolina, 27834

  • Prisma Health Endo Spc Thy Ctr

    Greenville, South Carolina, 29605

  • Encore Medical Research LLC

    Hollywood, Florida, 33024

  • Houston Endocrinology Center

    Houston, Texas, 77040

  • The Endocrine Center

    Houston, Texas, 77079

  • Amir Ali Hassan, MD, PA

    Houston, Texas, 77089

  • Rocky Mt Clin Res, LLC

    Idaho Falls, Idaho, 83404-7596

  • Indiana Uni School of Med-Ped

    Indianapolis, Indiana, 46202-5209

  • Northeast Research Institute

    Jacksonville, Florida, 32204

  • Scripps Whittier Diabetes Inst

    La Jolla, California, 92037

  • Palm Research Center Inc.

    Las Vegas, Nevada, 89148

  • Physicians Research Assoc. LLC

    Lawrenceville, Georgia, 30046

  • Loma Linda University Faculty Medical Clinics

    Loma Linda, California, 92354

  • Pacific Clinical Studies

    Los Alamitos, California, 90720

  • Los Angeles Institute for Metabolic Research

    Los Angeles, California, 90015

  • Robley Rex VA Medical Center

    Louisville, Kentucky, 40206

  • RGV Endocrine Center

    McAllen, Texas, 78503

  • Tekton Research

    McKinney, Texas, 75069

  • Life Spring Research Foundation LLC

    Miami, Florida, 33130

  • International Diabetes Center

    Minneapolis, Minnesota, 55416

  • Centricity Rsrch MHCity Multi

    Morehead City, North Carolina, 28557

  • MidState Endocrine Associates

    Nashville, Tennessee, 37203

  • Vanderbilt Medical Center_Nashville

    Nashville, Tennessee, 37212

  • Centricity Res New Bern Multispeciality

    New Bern, North Carolina, 28562

  • Suncoast Clinical Research, Inc.

    New Port Richey, Florida, 34652

  • NYC Research, Inc.

    New York, New York, 10016

  • NYU Langone Orthopedic Center

    New York, New York, 10017

  • Alliance for Multispecialty Research

    Norman, Oklahoma, 73069

  • Lynn Institute of Norman

    Norman, Oklahoma, 73069

  • West Orange Endocrinology

    Ocoee, Florida, 34761

  • Rio Clinical Trials

    Ogden, Utah, 84404

  • Lynn Institute - East OKC

    Oklahoma City, Oklahoma, 73111

  • MedStar Health Research Institute

    Olney, Maryland, 20832

  • QCR Network

    Omaha, Nebraska, 68114

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • Suncoast Clinical Research, Inc.

    Palm Harbor, Florida, 34684

  • Pasadena Clinical Trials

    Pasadena, California, 91101

  • Center for Diab,Obes & Metab

    Pembroke Pines, Florida, 33024

  • SRA Trials-Broward

    Pembroke Pines, Florida, 33024

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • WestenU Health

    Pomona, California, 91766

  • Hanson Clinical Research Center

    Port Charlotte, Florida, 33952

  • Accellacare of Raleigh

    Raleigh, North Carolina, 27609

  • Rainier Clin Res Ctr Inc

    Renton, Washington, 98057

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Endocrine Research Solutions, Inc

    Roswell, Georgia, 30076

  • Be Well Clinical Studies

    Round Rock, Texas, 78681

  • Texas Diabetes & Endocrinology_Round Rock

    Round Rock, Texas, 78681

  • Northeast Clinical Research of San Antonio

    San Antonio, Texas, 78233

  • Alliance Clinical Network

    San Diego, California, 92120

  • Mills Health Center

    San Mateo, California, 94401

  • Center for Endocrine DM and Metabolic Disorders

    Santa Clarita, California, 91321

  • Endeavor Health

    Skokie, Illinois, 60077

  • UVM Endocrinology

    South Burlington, Vermont, 05403

  • Saint Louis University

    St Louis, Missouri, 63103

  • Washington University

    St Louis, Missouri, 63110

  • Latin Clinical Trial Ctr

    Tamarac, Florida, 33321

  • Bayside Clinical Research

    Tampa, Florida, 33607

  • Cotton O'Neil Diabetes & Endocrinology

    Topeka, Kansas, 66606

  • University Clin Investigators

    Tustin, California, 92780

  • Diablo Clinical Research, Inc.

    Walnut Creek, California, 94598

  • Valley Diab. & Endo Comp Ctr

    Weslaco, Texas, 78596

  • Iowa Diabetes Research

    West Des Moines, Iowa, 50266

  • Metabolic Research Institute Inc

    West Palm Beach, Florida, 33401

  • University at Buffalo

    Williamsville, New York, 14221

  • Accellacare Wilmington

    Wilmington, North Carolina, 28401

Other trials in United States

Canada17 sites
  • Centricity Research Brampton Endocrinology

    Brampton, Ontario, L6S 0C6

  • Centricity Research Calgary Endocrinology

    Calgary, Alberta, T2H 2G4

  • University of Calgary

    Calgary, Alberta, T2T 5C7

  • Centricity Research Etobicoke Endocrinology

    Etobicoke, Ontario, M9R 4E1

  • Nova Scotia Health Authority

    Halifax, Nova Scotia, B3H 2Y9

  • Premier Clinical Trial Research Network (PCTRN)

    Hamilton, Ontario, L8L 5G4

  • Ctr de recherche Clinique de Laval

    Laval, Quebec, H7T 2P5

  • Western University Centre for Studies in Fam Med

    London, Ontario, N6G 2M1

  • Centricity Research Mirabel

    Mirabel, Quebec, J7J 2K8

  • McGill University Health Centre

    Montreal, Quebec, H4A 3J1

  • Clinique Endocrinologie OASIS.

    Montreal, Quebec, H4J 1E3

  • Clinique des Maladies Lipidiques de Quebec Inc.

    Québec, G1V 4W2

  • Centre de Médecine Métabolique de Lanaudière

    Terrebonne, Quebec, J6X 4P7

  • Centricity Research Toronto LMC Multispec

    Toronto, Ontario, M4G 3E8

  • Centricity Research LMC (Toronto)

    Toronto, Ontario, M9W 4L6

  • Vancouver General Hospital_Vancouver_0

    Vancouver, British Columbia, V5Z 1M9

  • Winnipeg Clinic

    Winnipeg, Manitoba, R3C 0N2

Other trials in Canada

Poland17 sites
  • Centrum Medyczne Intercor Sp. z o.o.

    Bydgoszcz, 85-605

  • Uniwersyteckie Centrum Kliniczne (UCK)

    Gdansk, 80-214

  • Med. Cent. Diabet. Endo. Metabol. DIAB-ENDO-MET

    Krakow, Lesser Poland Voivodeship, 31-261

  • Beata Miklaszewicz & Dariusz Dabrowski "CARDIAMED" s.j.

    Legnica, Lower Silesian Voivodeship, 59-220

  • Gabinet Lekarski Malgorzata Saryusz-Wolska

    Lodz, 90-132

  • Zanamed Medical Clinic Sp. z o.o.

    Lublin, 20-601

  • Reumed Sp. z o.o.

    Lublin, 20-607

  • ENDOPRACTICA W.Beker, D.Mielczarek, P.Mielczarek, J.Struzik spolka cywilna

    Opole, 45-301

  • Formed 2 Sp. z o.o.

    Oświęcim, Lesser Poland Voivodeship, 32-600

  • Formed 2 Sp. z o.o.

    Oświęcim, 32-600

  • Irmed Klimkiewicz Rudziewicz-Kowalska sp. j.

    Piotrkow Trybunalski, 97-300

  • Uniwersyteckie Centrum Stomatologii i Medycyny Specjalistycznej Sp. z o.o.

    Poznan, 60-354

  • Maciej Wiza Gaja Poradnie Lekarskie

    Poznan, 61-251

  • Metabolica Sp. z o.o.

    Tarnów, Lesser Poland Voivodeship, 33-100

  • PANSTWOWY INSTYTUT MEDYCZNY MSWiA

    Warsaw, 02-507

  • Zespol Wojewodzkich Przychodni Specjalistycznych W Katowicach SPZOZ

    Zabrze, 41-800

  • Etg Zamosc Sp. z o.o.

    Zamość, 22-400

Other trials in Poland

Germany16 sites
  • Diabetespraxis Mergentheim

    Bad Mergentheim, 97980

  • Herz- und Diabeteszentrum NRW - Bad Oeynhausen

    Bad Oeynhausen, 32545

  • Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR

    Berlin, 13597

  • DSP Bochum, Diabetes- und Stoffwechselpraxis

    Bochum, 44869

  • Uniklinik TU Dresden - Med. Klinik III

    Dresden, 01307

  • Praxis für Diabetologie, Angiologie und Innere Medizin Eisenach

    Eisenach, 99817

  • InnoDiab Forschung GmbH

    Essen, 45136

  • MVZ Diabeteszentrum Dr. Tews GmbH

    Gelnhausen, 63571

  • Diabetes-Zentrum-Wilhelmsburg GbR

    Hamburg, 21109

  • Diabetes Zentrum Wandsbek Berufsausuebungsgemeinschaft GbR

    Hamburg, 22041

  • Wendisch - Dahl Hamburg - DZHW

    Hamburg, 22607

  • Die Praxis am Ludwigsplatz

    Ludwigshafen, 67059

  • MedicalCenter am Clemenshospital - Schwerpunktpraxis für Diabetologie und Ernährungsmedizin

    Münster, 48153

  • Institut für Diabetesforschung Osnabrück

    Osnabrück, 49080

  • Zentrum für klinische Studien Alexander Segner

    Saint Ingbert-Oberwürzbach, 66386

  • Zentrum für klinische Studien Allgäu Oberschwaben

    Wangen, 88239

Other trials in Germany

Romania14 sites
  • CMI Dr. Pletea Noemi SRL

    Bacau, 600154

  • Minimed S.R.L.

    Bacau, 600238

  • Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed

    Brasov, 500283

  • SC Nutrilife SRL

    Bucharest, 013764

  • Diabs&Nutricare Srl

    Bucharest, 040172

  • Spitalul Clinic Judetean De Urgenta Sfantul Apostol Andrei Constanta

    Constanța, 900591

  • S.C. Top Diabet Srl

    Craiova, Dolj, 200515

  • SC Diamed Obesity SRL

    Galati, 800291

  • Diabmed Dr Popescu Alexandrina SRL

    Ploieşti, Prahova, 100179

  • S.C. Dianutrilife Medica S.R.L.

    Ploieşti, 100561

  • Clinica Korall S.R.L. Satu Mare

    Satu Mare, 440055

  • Spitalul Clinic Judetean de Urgenta Sibiu

    Sibiu, 550245

  • Spitalul Judetean De Urgenta Sfantul Ioan Cel Nou Suceava

    Suceava, 720224

  • Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara

    Timișoara, 300723

Other trials in Romania

Australia7 sites
  • St Vincent's Hospital Melbourne - Endocrinology & Diabetes Department

    Fitzroy, Victoria, 3065

  • Austin Health, Metabolic Disorders Centre

    Heidelberg Heights, Victoria, 3081

  • Macquarie University - Clinical Trials Unit

    Macquarie Park, New South Wales, 2109

  • Southern Adelaide Diabetes & Endocrine Services

    Oaklands Park, South Australia, 5046

  • The Royal Melbourne Hospital - Diabetes & Endocrinology Department

    Parkville, Victoria, 3050

  • Townsville University Hospital

    Townsville, Queensland, 4814

  • Illawarra Diabetes Service Clinical Trials & Research Unit

    Wollongong, New South Wales, 2500

Other trials in Australia

Slovakia6 sites
  • DIABEDA s.r.o.

    Bratislava, 831 06

  • MEDISPEKTRUM s.r.o.

    Bratislava, 851 01

  • Diab - Int, s.r.o.

    Bytča, 014 01

  • DIOLI s.r.o.

    Košice, 040 01

  • HUMAN-CARE, s.r.o.

    Košice, 040 01

  • DIADAN, s.r.o. Kosice

    Košice, 04011

Other trials in Slovakia

Puerto Rico2 sites
  • Centro de Endo Altagracia

    Bayamón, 00959

  • Advanced Clinical Research LLC

    Bayamón, 00961

Other trials in Puerto Rico

About this study

Official title: A 26-week Study Comparing the Efficacy and Safety of Once-weekly Insulin Icodec and Once-daily Insulin Glargine U100, Both in Combination With Insulin Aspart, in Adults With Type 1 Diabetes

This study compares insulin icodec, an insulin taken once a week to insulin glargine, an insulin taken once a day. The study medicine will be investigated in participants with type 1 diabetes. The study will look at how well insulin icodec taken weekly controls blood sugar compared to insulin glargine taken daily. The study will last for about 8.5 months.

Being tested
Insulin icodec, Insulin glargine, Insulin aspart
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

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

  • Insulin icodecDrug

    Insulin icodec will be administered as subcutaneous injection

  • Insulin glargineDrug

    Insulin glargine will be administered as subcutaneous injection.

  • Insulin aspartDrug

    Insulin aspart will be administered as a subcutaneous injection.

Study groups in NCT07076199
Study groupRoleWhat they receive
Insulin icodec + insulin aspartExperimentalParticipants will receive subcutaneously once weekly insulin icodec in combination with 2-4 times daily insulin aspart .
Receives: Drug: Insulin icodec; Drug: Insulin aspart
Insulin glargine+ insulin aspartActive comparatorParticipants will receive subcutaneously once daily insulin glargine in combination with 2-4 times daily insulin aspart.
Receives: Drug: Insulin glargine; Drug: Insulin aspart

What is being measured

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

  1. Change in glycosylated haemoglobin (HbA1c)

    Measured in percentage (%)-points.

    Measured: From baseline (week 0) to week 26

Secondary outcomes (9)
  1. Change in time in range 3.9-10.0 millimoles per liter (mmol/L) (70-180 milligrams per deciliter (mg/dL))

    Measured in %-points.

    Measured: From baseline (week-2-0) to week 22-26

  2. Time spent less than (<)3.0 mmol/L (54 mg/dL)

    Measured in % of time.

    Measured: From week 22 to week 26

  3. Change in time spent greater than (>)10.0 mmol/L (180 mg/dL)

    Measured in %-points.

    Measured: From baseline (week-2-0) to week 22-26

  4. Number of severe hypoglycaemic episodes (level 3)

    Measured as number of episodes.

    Measured: From baseline (week 0) to week 31

  5. Number of clinically significant hypoglycaemicepisodes (level 2) (<3.0mmol/L [54 mg/dL],confirmed by blood glucose (BG) meter)

    Measured as number of episodes.

    Measured: From baseline (week 0) to week 31

  6. Number of clinically significant hypoglycaemic episodes (level 2) (< 3.0 mmol/L [54 mg/dL], severe hypoglycaemic confirmed by BG meter) or episodes (level 3)

    Measured as number of episodes.

    Measured: From baseline (week 0) to week 31

  7. Number of continuous glucose continuous glucose (CGM)-based clinically significant hypoglycaemic episodes (level 2) (< 3.0 mmol/L [54 mg/dL])

    Measured as number of episodes.

    Measured: From baseline (week 0) to week 31

  8. Mean total weekly insulin dose

    Measured in insulin units.

    Measured: From week 24 to week 26

  9. Change in body weight

    Measured in Kilogram (kg).

    Measured: From baseline (week 0) to week 26

Timeline

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

  1. First posted22 Jul 2025
  2. Study start11 Aug 2025
  3. Primary completion25 Jan 2027 (estimated)
  4. Study completion1 Mar 2027 (estimated)

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
877 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07076199
Sponsor's protocol ID
NN1436-8182
Other IDs
U1111-1310-7017, 2024-519945-31
Acronym
ONWARDS 11
Status last verified
Sep 2026
First submitted
14 Jul 2025
Last updated
25 Sep 2026
Results posted
No
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 Insulin icodec, Insulin glargine and Insulin aspart in people with Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 182 sites in 8 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 4 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 182 sites in United States, Canada, Poland, Germany, Romania and 3 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?

This study is still under way. Results are not available in the source record yet.

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 glycosylated haemoglobin (HbA1c) (time frame: From baseline (week 0) to week 26). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 25 Sep 2026.

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