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AMBITION 7: A Research Study Investigating How Well Zenagamtide Lowers Blood Sugar and Body Weight Compared to Insulin Glargine in People With Type 2 Diabetes and Increased Risk of Diseases That Affect the Heart and Blood Vessels Treated With 1-3 Other Diabetes Medications (AMBITION 7)

26. august 2026 opdateret af: Novo Nordisk A/S

Efficacy and Safety of Zenagamtide s.c. Once Weekly Compared to Insulin Glargine s.c. Once Daily in Participants With Type 2 Diabetes and Increased Cardiovascular Risk Inadequately Controlled on 1-3 Oral Glucose-lowering Medications (AMBITION 7)

This study is being conducted to find out how well zenagamtide works and how safe it is compared to insulin glargine in participants with type 2 diabetes who are at higher risk of heart and blood vessel problems and are already taking 1 to 3 diabetes medications. There are 2 study treatments in this study taken as injections under the skin once a week. Participants will either get zenagamtide, (the treatment being tested) or insulin glargine (a comparator) and which treatment participants get is decided by chance.

Studieoversigt

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

1778

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

      • Buenos Aires, Argentina, C1425AGC
        • Ikke rekrutterer endnu
        • Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli
      • Buenos Aires, Argentina, C1015
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        • OMI- Organización Médica de Investigación
      • Buenos Aires, Argentina, C1419
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        • Hospital Sirio Libanês
      • CABA, Argentina, C1120AAC
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        • Centro Medico Viamonte SRL
      • CABA, Argentina, C1061AAS
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        • CIPREC Arenales
      • CABA, Argentina, C1440AAD
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        • CENUDIAB Centro Médico de Nutrición v Diabetes
      • Córdoba, Argentina, X5008
        • Ikke rekrutterer endnu
        • Centro Medico Privado CEMAIC
      • Córdoba, Argentina, 5000
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        • Centro Diabetologico Cordoba Dr. Waitman
      • Godoy Cruz, Argentina, M5501ARP
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        • CIPADI
      • San Miguel de Tucumán, Argentina, T4000IHE
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        • Clínica Mayo de Urgencias Médicas Cruz Blanca
    • Buenos Aires
      • Bahía Blanca, Buenos Aires, Argentina, B8000
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        • Instituto de Investigaciones Clínicas Bahia Blanca
      • CABA, Buenos Aires, Argentina, C1440CFD
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        • CEMEDIC
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1048
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        • Dolz Investigacion Clinica
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1426
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        • Fundacion Respirar
      • Mar del Plata, Buenos Aires, Argentina, B7600GNY
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        • Centro de Investigaciones Medicas Mar del Plata
    • Mendoza Province
      • San Rafael, Mendoza Province, Argentina, M5602GGS
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        • CIMRO
    • San Juan Province
      • San Juan, San Juan Province, Argentina, J5400
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        • Centro Oncológico de Excelencia (COE)
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, S2000DEJ
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        • Fundacion Estudios Clinicos
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      • Uberlândia, Minas Gerais, Brasilien, 38400-500
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      • Newquay, Cornwall, Det Forenede Kongerige, TR7 1RU
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      • Rotherham, South Yorkshire, Det Forenede Kongerige, S65 1DA
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        • Clifton Medical Centre
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35294
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        • Univ of Alabama Birmingham
      • Fairhope, Alabama, Forenede Stater, 36532
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    • Arizona
      • Scottsdale, Arizona, Forenede Stater, 85258
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        • Honor Health
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        • N America Res Inst - San Dimas
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    • Florida
      • Clearwater, Florida, Forenede Stater, 33756
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        • Innovative Research of W FL
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        • Nature Coast Clin Rsrch_Crystal River
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        • Florida Premier Cardiology
      • Hollywood, Florida, Forenede Stater, 33024
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        • Encore Medical Research LLC
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        • East Coast Institute for Research
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        • Jacksonville Ctr for Clin Res
      • Lakeland, Florida, Forenede Stater, 33805
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        • Clinical Research of Cent FL
      • Miami, Florida, Forenede Stater, 33130
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        • Life Spring Research Foundation LLC
      • Miami, Florida, Forenede Stater, 33135
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        • Optimus U, Corp
      • Miami, Florida, Forenede Stater, 33138
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        • Flourish Research - North Miami
      • Miami Lakes, Florida, Forenede Stater, 33014
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        • San Marcus Res Clin Miami Lakes
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        • Inpatient Research Clinic LLC
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        • Trujillo Medical Centers
      • New Port Richey, Florida, Forenede Stater, 34652
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        • Suncoast Clinical Research, Inc.
      • Ocala, Florida, Forenede Stater, 34471
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        • Ocala Cardiovascular Research
      • Palm Harbor, Florida, Forenede Stater, 34684
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        • Suncoast Clinical Research, Inc.
      • Pembroke Pines, Florida, Forenede Stater, 33024
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        • Suncoast Research Associates LLC
      • Saint Augustine, Florida, Forenede Stater, 32086
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        • St Johns Center for Clin. Res
    • Georgia
      • Albany, Georgia, Forenede Stater, 31707
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        • Javara/Privia Med Grp GA,LLC
      • Cordele, Georgia, Forenede Stater, 31015
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        • David Kavtaradze MD, Inc.
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        • Atlanta Heart Specialist
    • Idaho
      • Idaho Falls, Idaho, Forenede Stater, 83404
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        • Rocky Mountain Diab&Osteo Ctr
    • Illinois
      • Gurnee, Illinois, Forenede Stater, 60031
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        • Genesis Orthopedics & Sports Medicine
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        • Methodist Medical Center of Illinois
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      • Franklin, Indiana, Forenede Stater, 46131
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        • American Health Network of IN LLC
    • Iowa
      • Council Bluffs, Iowa, Forenede Stater, 51501
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        • West Broadway Clinic
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        • University of Iowa Prev Inter Ctr
      • West Des Moines, Iowa, Forenede Stater, 50266
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        • Iowa Diab & Endo Res Center
    • Kansas
      • Topeka, Kansas, Forenede Stater, 66606
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    • Kentucky
      • Lexington, Kentucky, Forenede Stater, 40503
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        • The Research Group of Lexington LLC
    • Louisiana
      • Covington, Louisiana, Forenede Stater, 70433
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        • Louisiana Heart Center
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21229
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        • Ascension Saint Agnes Heart Ca
      • Baltimore, Maryland, Forenede Stater, 21239
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        • MedStar Good Samaritan Hosp
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02115
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        • Brigham & Women's Hospital
    • Michigan
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        • Henry Ford Health System
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        • Elite Research Center
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        • Arcturus Healthcare, PLC.
      • Ypsilanti, Michigan, Forenede Stater, 48197
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        • Trinity Health Michigan Heart
    • Missouri
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        • Johnson County ClinTrials
      • St Louis, Missouri, Forenede Stater, 63128
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        • Amicis Centers of Clinical Research
    • Nebraska
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        • Methodist Phys. Clinic
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      • Las Vegas, Nevada, Forenede Stater, 89128
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        • Palm Research Center Inc-Vegas
    • New York
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        • Mid Hudson Med Res-New Windsor
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        • Harlem Cardiology_Madison ave
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        • NYC Health + Hospitals/Lincoln
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        • Southgate Medical Group, LLP
    • North Carolina
      • Morehead City, North Carolina, Forenede Stater, 28557
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        • Carteret Medical Group
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        • Piedmont Healthcare/Research
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        • Accellacare
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45267
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        • Univ of Cincinnati Med Cent
      • Maumee, Ohio, Forenede Stater, 43537
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        • Advanced Med Res Maumee
    • Oklahoma
      • Norman, Oklahoma, Forenede Stater, 73072
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        • Lynn Institute of Norman
    • Pennsylvania
      • Beaver, Pennsylvania, Forenede Stater, 15009
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        • Heritage Valley Medical Group
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    • South Carolina
      • Fort Mill, South Carolina, Forenede Stater, 29707
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        • Piedmont Research Partners, LLC
      • Mt. Pleasant, South Carolina, Forenede Stater, 29464
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        • Accellacare US Inc._SC
      • Myrtle Beach, South Carolina, Forenede Stater, 29572
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        • Trial Management Associates
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        • Holston Medical Group Pc
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        • The Alliance for Multispecialty Research LLC AMR
      • Nashville, Tennessee, Forenede Stater, 37203
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        • MidState Endocrine Associates
    • Texas
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        • PharmaTex Research
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        • Pinnacle Clinical Research
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        • Javara Inc. / Privia Medical Group Gulf Coast PLLC
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        • Osvaldo A. Brusco MD
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        • Thyroid Endocrinology & Diabetes PA
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        • Baylor Jack and Jane Hamilton
      • Fort Worth, Texas, Forenede Stater, 76132
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        • Diabetes and Thyroid Ctr of FW
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        • Primecare Medical Group
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        • JCCT- Juno NW Houston
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        • DCOL Ctr for Clin Res
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        • Texas Inst, Kdny & Endo Disor
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        • PRX Research
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        • NE Clin Res of San Antonio
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        • Univ Of Texas Hlth Science Cntr
      • San Antonio, Texas, Forenede Stater, 78212
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        • Clinical Advancement Center
      • San Antonio, Texas, Forenede Stater, 78229
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        • The IMA Group IMA Clinical Trials of America Inc. CTA
      • Sugar Land, Texas, Forenede Stater, 77478
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        • Simcare Medical Research, LLC
      • Weslaco, Texas, Forenede Stater, 78596
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        • Valley Diab. & Endo Comp Ctr
    • Utah
      • Bountiful, Utah, Forenede Stater, 84010
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        • Progressive Clinical Research UT
      • Layton, Utah, Forenede Stater, 84041
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        • Alpine Research Association
      • Salt Lake City, Utah, Forenede Stater, 84107
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        • Wasatch Clinical Research, LLC
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      • Manassas, Virginia, Forenede Stater, 20109
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        • Carient Heart and Vascular
      • Richmond, Virginia, Forenede Stater, 23219
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        • Dominion Medical Associates
      • Salem, Virginia, Forenede Stater, 24153
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        • VA Medical Center_Salem
      • Winchester, Virginia, Forenede Stater, 22601-3834
        • Rekruttering
        • Selma Medical Associates
      • Athens, Grækenland, 115 27
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        • Laiko General Hospital Of Athens - 1st department of Internal Medicine
      • Athens, Grækenland, 10676
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        • Evangelismos S.A. - Endocrinology department
      • Athens, Grækenland, 115 25
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        • 251 Air Force General Hospital - Department of Endocrinology & Diabetes
      • Athens, Grækenland, 11527
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        • General Hospital Of Athens G Gennimatas - Department of Endocrinology
      • Efkarpia, Grækenland, 564 29
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        • General Hospital Of Thessaloniki Papageorgiou - 3rd Department of Internal Medicine
      • Heraklion, Grækenland, 71500
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        • University General Hospital Of Heraklion - Nephrology Department
      • Peristeri, Grækenland, 121 31
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        • Athens Medical Center S.A. (Iatriko Peristeriou) - Diabetes, obesity and cardiometabolic diseases department
      • Rio, Patra, Grækenland, 26504
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        • General University Hospital of Patras,Nephrology clinic
      • Thessaloniki, Grækenland, 546 42
        • Ikke rekrutterer endnu
        • Ippokratio General Hospital Of Thessaloniki - 2nd Propaedeutic Department of Internal Medicine
      • Thessaloniki, Grækenland, 546 42
        • Ikke rekrutterer endnu
        • Ippokratio General Hospital Of Thessaloniki - B' Internal Medicine clinic
      • Thessaloniki, Grækenland, 570 10
        • Ikke rekrutterer endnu
        • Geniko Nosokomeio Thessalonikis George Papanikolaou - Internal Medicine and Diabetes Department
      • Νikaia, Grækenland, 184 54
        • Ikke rekrutterer endnu
        • Geniko Nosokomeio Nikaias Peiraia Ag. Panteleimon Geniko Nosokomeio Dytikis Attikis I - Nephrology Department
      • Jaipur, Indien, 302004
        • Ikke rekrutterer endnu
        • SMS Hospital
      • New Delhi, Indien, 110029
        • Ikke rekrutterer endnu
        • All India Institute of Medical Sciences (AIIMS)
    • Andhra Pradesh
      • Guntur, Andhra Pradesh, Indien, 522001
        • Ikke rekrutterer endnu
        • Endolife Specialty Hospitals
    • Chhattisgarh
      • Raipur, Chhattisgarh, Indien, 492099
        • Ikke rekrutterer endnu
        • All India Institute of Medical Sciences (AIIMS), Raipur
    • Gujarat
      • Surat, Gujarat, Indien, 395001
        • Ikke rekrutterer endnu
        • Nirmal Hospital Pvt. Ltd.
      • Vadodara, Gujarat, Indien, 390001
        • Ikke rekrutterer endnu
        • SSG Hospital, Baroda
    • Karnataka
      • Bangalore, Karnataka, Indien, 560092
        • Ikke rekrutterer endnu
        • Life Care Hospital and Research Centre
    • Kerala
      • Kochi, Kerala, Indien, 682041
        • Ikke rekrutterer endnu
        • Amrita Institute of Medical Sciences & Research Centre
      • Kozhikode, Kerala, Indien, 673008
        • Ikke rekrutterer endnu
        • Government Medical College, Kozhikode
    • Madhya Pradesh
      • Indore, Madhya Pradesh, Indien, 452010
        • Ikke rekrutterer endnu
        • TOTALL Diabetes Hormone Institute
    • Maharashtra
      • Mumbai, Maharashtra, Indien, 400058
        • Ikke rekrutterer endnu
        • BSES MG Hospital
      • Nagpur, Maharashtra, Indien, 440010
        • Ikke rekrutterer endnu
        • Sunil's Diabetes Care n' Research Centre Pvt Ltd
      • Pune, Maharashtra, Indien, 411021
        • Ikke rekrutterer endnu
        • Chellaram Diabetes Institute
      • Thane, Maharashtra, Indien, 421004
        • Ikke rekrutterer endnu
        • Ashirwad Hospital and Research Centre
    • Odisha
      • Bhubaneswar, Odisha, Indien, 751019
        • Ikke rekrutterer endnu
        • All India Institute of Medical Sciences (AIIMS), Bhubaneswar
    • Punjab
      • Ludhiana, Punjab, Indien, 141002
        • Ikke rekrutterer endnu
        • Deep Healthcare Private Limited.
    • Rajasthan
      • Jaipur, Rajasthan, Indien, 302006
        • Ikke rekrutterer endnu
        • Diabetes, Thyroid and Endocrine Centre
    • Tamil Nadu
      • Coimbatore, Tamil Nadu, Indien, 641018
        • Ikke rekrutterer endnu
        • KG Hospital and PG Medical Institute & Research Centre
      • Vellore, Tamil Nadu, Indien, 632004
        • Ikke rekrutterer endnu
        • Christian Medical College Hospital, Vellore
    • Telangana
      • Hyderabad, Telangana, Indien, 500082
        • Ikke rekrutterer endnu
        • Nizam's Institute of Medical Sciences
      • Hyderabad, Telangana, Indien, 500012
        • Ikke rekrutterer endnu
        • Osmania General Hospital_Hyderabad
      • Milan, Italien, 20142
        • Ikke rekrutterer endnu
        • ASST Santi Paolo e Carlo - Ospedale San Paolo - Diabetologia
    • Abruzzo
      • Chieti, Abruzzo, Italien, 66100
        • Ikke rekrutterer endnu
        • Università degli studi G. D'Annunzio di Chieti - CAST - Centro Ricera Clinica (CRC)
    • Calabria
      • Catanzaro, Calabria, Italien, 88100
        • Ikke rekrutterer endnu
        • AOU Renato Dulbecco - Unità Operativa Complessa Medicina Interna
    • Campania
      • Naples, Campania, Italien, 80131
        • Ikke rekrutterer endnu
        • AOU Federico II Di Napoli - DAI Endocr. Diab. Andro. e Nutr. - UOC Endocrinologia Diabetologia e Andrologia
    • Emilia-Romagna
      • Ravenna, Emilia-Romagna, Italien, 48121
        • Ikke rekrutterer endnu
        • AUSL Romagna - Medicine Specialistiche Ravenna - UO Servizio di Diabetologia di Ravenna
    • Liguria
      • Chiavari, Liguria, Italien, 16043
        • Ikke rekrutterer endnu
        • Polo Ospedaliero di Chiavari - S.S.D. Diabetologia e Malattia Metaboliche
    • Lombardy
      • Milan, Lombardy, Italien, 20132
        • Ikke rekrutterer endnu
        • Ospedale San Raffaele S.r.l. - Medicina Generale Indirizzo Diabetologico ed Endocrino-Metabolico
    • RM
      • Roma, RM, Italien, 00161
        • Ikke rekrutterer endnu
        • Policlinico Umberto I Seconda Clinica Medica
    • Tuscany
      • Lucca, Tuscany, Italien, 55100
        • Ikke rekrutterer endnu
        • AUSL Toscana Nord Ovest - Cittadella della Salute Campo di Marte - Diabetologia Lucca e Valle del Serchio
    • Anhui
      • Hefei, Anhui, Kina, 230012
        • Ikke rekrutterer endnu
        • The Second People's Hospital of Hefei-Endocrinology
      • Hefei, Anhui, Kina, 230061
        • Ikke rekrutterer endnu
        • The Second Hospital of Anhui Medical University-Endocrinology
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina, 100044
        • Ikke rekrutterer endnu
        • Peking University People's Hospital-Endocrinology
      • Beijing, Beijing Municipality, Kina, 100037
        • Ikke rekrutterer endnu
        • Chinese Academy of Medical Sciences Fuwai Hospital-Endocrinology
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, Kina, 400010
        • Ikke rekrutterer endnu
        • The Second Affiliated Hospital of Chongqing Medical University-Endocrinology
      • Chongqing, Chongqing Municipality, Kina, 404199
        • Ikke rekrutterer endnu
        • Chongqing University Three Gorges Hospital-Endocrinology
    • Guangdong
      • Shenzhen, Guangdong, Kina, 518035
        • Ikke rekrutterer endnu
        • The Second People's Hospital of Shenzhen-Endocrinology
    • Hebei
      • Cangzhou, Hebei, Kina, 061000
        • Ikke rekrutterer endnu
        • Cangzhou People's Hospital-Endocrinology
      • Langfang, Hebei, Kina, 065099
        • Ikke rekrutterer endnu
        • Hebei PetroChina Central Hospital-Endocrinology
      • Shijiazhuang, Hebei, Kina, 050000
        • Ikke rekrutterer endnu
        • The Second Hospital of Hebei Medical University-Endocrinology
      • Shijiazhuang, Hebei, Kina, 050023
        • Ikke rekrutterer endnu
        • The First Hospital of Hebei Medical University-Endocrinology
    • Henan
      • Kaifeng, Henan, Kina, 475000
        • Ikke rekrutterer endnu
        • Huaihe Hospital of Henan University-Endocrinology
      • Luoyang, Henan, Kina, 471003
        • Ikke rekrutterer endnu
        • The First Affiliated Hospital of Henan University of Science and Technology-Endocrinology
      • Luoyang, Henan, Kina, 471002
        • Ikke rekrutterer endnu
        • Luoyang First People's Hospital-Endocrinology
      • Nanyang, Henan, Kina, 473058
        • Ikke rekrutterer endnu
        • The First Affiliated Hospital of Nanyang Medical College-Endocrinology
      • Zhengzhou, Henan, Kina, 450003
        • Ikke rekrutterer endnu
        • The Second Affiliated Hospital of Zhengzhou University-Endocrinology
      • Zhengzhou, Henan, Kina, 450052
        • Ikke rekrutterer endnu
        • The First Affiliated Hospital of Zhengzhou University-Endocrinology
    • Hubei
      • Shiyan, Hubei, Kina, 442008
        • Ikke rekrutterer endnu
        • Shiyan Taihe Hospital (Affiliated Hospital of Hubei University of Medicine)-Endocrinology
    • Hunan
      • Changde, Hunan, Kina, 415003
        • Ikke rekrutterer endnu
        • The First People's Hospital of Changde City-Endocrinology
    • Jiangsu
      • Changzhou, Jiangsu, Kina, 213004
        • Ikke rekrutterer endnu
        • The First People's Hospital of Changzhou-Endocrinology
      • Changzhou, Jiangsu, Kina, 213164
        • Ikke rekrutterer endnu
        • Changzhou No.2 People's Hospital-Endocrinology
      • Nanjing, Jiangsu, Kina, 210011
        • Ikke rekrutterer endnu
        • The Second Affiliated Hospital of Nanjing Medical University-Endocrinology
      • Nanjing, Jiangsu, Kina, 210006
        • Ikke rekrutterer endnu
        • Nanjing First Hospital-Endocriniology
      • Nanjing, Jiangsu, Kina, 211199
        • Ikke rekrutterer endnu
        • Nanjing Jiangning Hospital-Endocrinology
      • Suzhou, Jiangsu, Kina, 215004
        • Ikke rekrutterer endnu
        • The Second Affiliated Hospital of Soochow University-Endocrinology
      • Zhenjiang, Jiangsu, Kina, 212001
        • Ikke rekrutterer endnu
        • The Affiliated Hospital of Jiangsu University-Endocrinology
    • Jilin
      • Changchun, Jilin, Kina, 130061
        • Ikke rekrutterer endnu
        • The First Bethune hospital of Jilin University-Endocrinology
      • Jilin City, Jilin, Kina, 130041
        • Ikke rekrutterer endnu
        • The Second Norman Bethune Hospital of Jilin University-Endocrinology
    • Liaoning
      • Panjin, Liaoning, Kina, 124120
        • Ikke rekrutterer endnu
        • Panjin Liaoyou Gemflower Hospital-Endocrinology
    • Qinghai
      • Xining, Qinghai, Kina, 810007
        • Ikke rekrutterer endnu
        • Qinghai Provincial People's Hospital-Endocrinology
    • Shandong
      • Jinan, Shandong, Kina, 250013
        • Ikke rekrutterer endnu
        • Jinan Central Hospital-General Medicine
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Kina, 201199
        • Ikke rekrutterer endnu
        • Central Hospital of Minhang District, Shanghai-Endocrinology
    • Sichuan
      • Chengdu, Sichuan, Kina, 610071
        • Ikke rekrutterer endnu
        • Sichuan Academy of Medical Science & Sichuan Provincial People's Hospital; Affiliated Hospital of UESTC-Endocrinology
    • Zhejiang
      • Huzhou, Zhejiang, Kina, 313000
        • Ikke rekrutterer endnu
        • Huzhou Central Hospital-Endocrinology
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44670
        • Ikke rekrutterer endnu
        • Centro de Investigacion Clinica Endocrinologica de Jalisco
      • Guadalajara, Jalisco, Mexico, 44600
        • Ikke rekrutterer endnu
        • Instituto Jalisciense de Investigacion en Diabetes y Obesidad
      • Guadalajara, Jalisco, Mexico, 44600
        • Ikke rekrutterer endnu
        • Diseño y Planeación en Investigación Médica S.C.
    • Mexico City
      • Tlalpan, Mexico City, Mexico, 14080
        • Ikke rekrutterer endnu
        • Instituto Nacional de Ciencias Médicas y Nutrición
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64020
        • Ikke rekrutterer endnu
        • Alliance CEINV Salud S.A. de C.V.
    • Sonora
      • Hermosillo, Sonora, Mexico, 83280
        • Ikke rekrutterer endnu
        • Investigación Médica Sonora S.C.
    • Tamaulipas
      • Ciudad Madero, Tamaulipas, Mexico, 89440
        • Ikke rekrutterer endnu
        • Centro de Estudios de Investigación Metabólicos y Cardio
      • Ciudad Madero, Tamaulipas, Mexico, 89450
        • Ikke rekrutterer endnu
        • SIYODE S.A. de C.V. Unimeden
    • Yucatán
      • Merida Centro, Yucatán, Mexico, 97070
        • Ikke rekrutterer endnu
        • Centro de Desarrollo Biomédico S.C.P.
      • Mérida, Yucatán, Mexico, 97070
        • Ikke rekrutterer endnu
        • Medical Care and Research S. A de C.V
      • Bialystok, Polen, 15-351
        • Ikke rekrutterer endnu
        • Osteo-Medic s.c. A. Racewicz, J. Supronik
      • Bialystok, Polen, 15-481
        • Ikke rekrutterer endnu
        • Kresmed Sp. z o. o.
      • Bialystok, Polen, 15-269
        • Ikke rekrutterer endnu
        • Uniwersytecki Szpital Kliniczny w Bialymstoku
      • Bolesławiec, Polen, 59-700
        • Ikke rekrutterer endnu
        • Zespol Opieki Zdrowotnej w Boleslawcu
      • Chorzów, Polen, 41-516
        • Ikke rekrutterer endnu
        • Diab Serwis Popenda Spółka Jawna
      • Katowice, Polen, 40-600
        • Ikke rekrutterer endnu
        • Gyncentrum Sp. z o. o.
      • Libiąż, Polen, 32-590
        • Ikke rekrutterer endnu
        • Centrum Medyczne MBB-MED Marta Blach-Burek
      • Lodz, Polen, 90-132
        • Ikke rekrutterer endnu
        • Gabinet Lekarski Malgorzata Saryusz-Wolska
      • Lodz, Polen, 91-495
        • Ikke rekrutterer endnu
        • Amicare Sp. z o.o. S.K.
      • Lublin, Polen, 20-362
        • Ikke rekrutterer endnu
        • Velocity Nova Sp. z o.o.
      • Olsztyn, Polen, 10-117
        • Ikke rekrutterer endnu
        • Etyka Osrodek Badan Klinicznych Tomasz Pesta S.K.A.
      • Piotrkow Trybunalski, Polen, 97-300
        • Ikke rekrutterer endnu
        • Irmed Klimkiewicz Rudziewicz-Kowalska sp. j.
      • Poznan, Polen, 61-251
        • Ikke rekrutterer endnu
        • Maciej Wiza Gaja Poradnie Lekarskie
      • Poznan, Polen, 60-589
        • Ikke rekrutterer endnu
        • Centrum Zdrowia Metabolicznego Paweł Bogdański
      • Puławy, Polen, 24-100
        • Ikke rekrutterer endnu
        • Velocity Nova Sp. z o.o.
      • Rzeszów, Polen, 35-055
        • Ikke rekrutterer endnu
        • Centrum Medyczne Medyk Sp.zo.o. Sp.k.
      • Torun, Polen, 87-100
        • Ikke rekrutterer endnu
        • Medicover Integrated Clinical Services Sp. z o.o.
      • Warsaw, Polen, 02-507
        • Ikke rekrutterer endnu
        • Państwowy Instytut Medyczny MSWiA
      • Warsaw, Polen, 00-739
        • Ikke rekrutterer endnu
        • Szpital Czerniakowski Sp. z o.o.
      • Wroclaw, Polen, 50-127
        • Ikke rekrutterer endnu
        • Regionalna Poradnia Diabetologiczna-Zytkiewicz-Jaruga, Stasinska Spolka Partnerska Lekarzy
      • Zamość, Polen, 22-400
        • Ikke rekrutterer endnu
        • Velocity Nova Sp. z o.o.
      • Żyrardów, Polen, 96-300
        • Ikke rekrutterer endnu
        • Prywatna Praktyka Lekarska Anna Chudoba
    • Lublin Voivodeship
      • Lublin, Lublin Voivodeship, Polen, 20-601
        • Ikke rekrutterer endnu
        • Zana-Med Medical Group Sp. z o.o.
    • Podlaskie Voivodeship
      • Bialystok, Podlaskie Voivodeship, Polen, 15-879
        • Ikke rekrutterer endnu
        • NZOZ Vita-Diabetica Malgorzata Buraczyk
    • Silesian Voivodeship
      • Chorzów, Silesian Voivodeship, Polen, 41-500
        • Ikke rekrutterer endnu
        • M2M Med. Badania Sp. z o.o.
      • A Coruña, Spanien, 15006
        • Ikke rekrutterer endnu
        • CHUAC_Endocrinología
      • Barcelona, Spanien, 08035
        • Ikke rekrutterer endnu
        • Hosp. Vall d'Hebrón_Endocrinología
      • Barcelona, Spanien, 08036
        • Ikke rekrutterer endnu
        • Clinic Barcelona_Endocrinología
      • Móstoles, Spanien, 28935
        • Ikke rekrutterer endnu
        • Hospital de Mostoles_Endocrinología
      • Sanlúcar de Barrameda, Spanien, 11540
        • Ikke rekrutterer endnu
        • H Virgen del Camino_Sanlúcar_Medicina Interna
      • Santiago de Compostela, Spanien, 15706
        • Ikke rekrutterer endnu
        • CHUS_Endocrinología
      • Segovia, Spanien, 40002
        • Ikke rekrutterer endnu
        • Hospital General de Segovia_Endocrinología
      • Valencia, Spanien, 46014
        • Ikke rekrutterer endnu
        • Hospital General de Valencia_Endocrinología
      • Brno, Tjekkiet, 615 00
        • Ikke rekrutterer endnu
        • EFERTUS healthcare s.r.o.
      • Broumov, Tjekkiet, 550 01
        • Ikke rekrutterer endnu
        • Edumed s.r.o.
      • Dolní Břežany, Tjekkiet, 252 41
        • Ikke rekrutterer endnu
        • Poliklinika Dolní Břežany
      • Hradec Králové, Tjekkiet, 500 02
        • Ikke rekrutterer endnu
        • Medika Hradec Králové s.r.o.
      • Náchod, Tjekkiet, 547 01
        • Ikke rekrutterer endnu
        • Edumed s.r.o.
      • Ostrava, Tjekkiet, 700 30
        • Ikke rekrutterer endnu
        • MUDr. SRPOVÁ s.r.o.
      • Ostrava, Tjekkiet, 710 00
        • Ikke rekrutterer endnu
        • Donmed s.r.o.
      • Pardubice, Tjekkiet, 530 02
        • Ikke rekrutterer endnu
        • Pratia Pardubice a.s.
      • Pilsen, Tjekkiet, 326 00
        • Ikke rekrutterer endnu
        • MUDr. Jitka Zemanova - diabetologie a interna, s.r.o.
      • Prague, Tjekkiet, 140 21
        • Ikke rekrutterer endnu
        • IKEM
      • Prague, Tjekkiet, 140 00
        • Ikke rekrutterer endnu
        • MEDICON a.s.
      • Prague, Tjekkiet, 17000
        • Ikke rekrutterer endnu
        • Diantel s.r.o.
      • Český Krumlov, Tjekkiet, 381 01
        • Ikke rekrutterer endnu
        • Nemocnice Český Krumlov, a.s.
      • Adana, Tyrkiet (Türkiye), 01060
        • Ikke rekrutterer endnu
        • Adana Şehir Eğitim ve Araştırma Hastanesi
      • Adana /yüreği̇r, Tyrkiet (Türkiye), 01240
        • Ikke rekrutterer endnu
        • Başkent Üniversitesi Adana Dr. Turgut Noyan Uygulama ve Araştırma Merkezi -Endokrinoloji
      • Adapazarı/Turkiye, Tyrkiet (Türkiye), 54100
        • Ikke rekrutterer endnu
        • Sakarya Egitim ve Arastirma Hastanesi-Nefroloji
      • Afyonkarahisar, Tyrkiet (Türkiye), 03200
        • Ikke rekrutterer endnu
        • Afyonkarahisar Sağlık Bilimleri Üniversitesi Sağlık Uygulama Ve Araştırma Merkezi- Nefroloji
      • Ankara, Tyrkiet (Türkiye), 06800
        • Ikke rekrutterer endnu
        • Ankara Bilkent Şehir Hastanesi-Dahiliye
      • Gaziantep, Tyrkiet (Türkiye), 27070
        • Ikke rekrutterer endnu
        • Gaziantep Üniversitesi Hastanesi- Endokrinoloji
      • Istanbul, Tyrkiet (Türkiye), 34722
        • Ikke rekrutterer endnu
        • Göztepe Prof. Dr.Süleyman Yalçın Şehir Hastanesi- Dahiliye
      • Izmir, Tyrkiet (Türkiye), 35100
        • Ikke rekrutterer endnu
        • Ege Üniversitesi Tip Fakultesi Hastanesi - Nefroloji
      • Kayseri, Tyrkiet (Türkiye), 38039
        • Ikke rekrutterer endnu
        • Erciyes Üniversitesi Hastanesi- Kardiyoloji
      • Kocaeli, Tyrkiet (Türkiye), 41380
        • Ikke rekrutterer endnu
        • Kocaeli Üniversitesi Araştıma ve Uygulama Hastanesi - Nefroloji
      • Nilüfer/Bursa, Tyrkiet (Türkiye), 16140
        • Ikke rekrutterer endnu
        • Bursa Yüksek İhtisas Eğitim ve Araştırma Merkezi-Endokrinoloji
      • Odunpazarı /Eskişehir, Tyrkiet (Türkiye), 26080
        • Ikke rekrutterer endnu
        • Eskişehir Şehir Hastanesi- Kardiyoloji
      • Sivas, Tyrkiet (Türkiye), 58140
        • Ikke rekrutterer endnu
        • Sivas Cumhuriyet Üniversitesi Hastanesi -Endokrinoloji
      • Sur / Diyarbakır, Tyrkiet (Türkiye), 21280
        • Ikke rekrutterer endnu
        • Dicle Üniversitesi Tıp Fakültesi Sağlık Ve Araştırma Hastanesi- Nefroloji
    • Melikgazi
      • Kayseri, Melikgazi, Tyrkiet (Türkiye), 38039
        • Ikke rekrutterer endnu
        • Erciyes Üniversitesi Hastanesi - Nefroloji
      • Deggingen, Tyskland, 73326
        • Ikke rekrutterer endnu
        • Medizinisches Versorgungszentrum Jung GbR
      • Essen, Tyskland, 45355
        • Ikke rekrutterer endnu
        • Praxis am Markt Dr. Becker
      • Gelnhausen, Tyskland, 63571
        • Ikke rekrutterer endnu
        • MVZ Diabeteszentrum Dr. Tews GmbH
      • Hamburg, Tyskland, 21109
        • Ikke rekrutterer endnu
        • Diabetes-Zentrum-Wilhelmsburg GbR
      • Hamburg, Tyskland, 22041
        • Ikke rekrutterer endnu
        • Diabetes Zentrum Wandsbek Berufsausuebungsgemeinschaft GbR
      • Hohenmölsen, Tyskland, 06679
        • Ikke rekrutterer endnu
        • Dr. Milek medikum
      • Jerichow, Tyskland, 39319
        • Ikke rekrutterer endnu
        • Praxisgemeinschaft Jerichow
      • Leipzig, Tyskland, 04249
        • Ikke rekrutterer endnu
        • Gemeinschaftspraxis Dr. Täschner/Dr. Bonigut
      • Ratingen, Tyskland, 40882
        • Ikke rekrutterer endnu
        • Sanos Clinic GmbH Ratingen

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
  • Male or female (sex assigned at birth, inclusive of all gender identities).
  • Age 45 years or above at the time of signing the informed consent.
  • Diagnosed with type 2 diabetes (T2D) greater than or equal to (≥) 180 days before screening.
  • Treatment with 1-3 marketed oral glucose-lowering medications (metformin, glinide, thiazolidinedione, sodium-glucose cotransporter-2 inhibitors (SGLT2i), α-glucosidase inhibitors (AGI), or sulfonylureas (SU) as a single agent or in combination) according to local label. Treatment with oral glucose-lowering medications must be stable (same drug(s), stable daily dose(s)) before screening.
  • Have HbA1c as determined by central laboratory at screening, if background glucose-lowering medications does not include a SU, or if background glucose-lowering medications includes a SU.
  • Increased risk of cardiovascular events as evidenced by at least one of the following (a-e):
  • Prior myocardial infarction (MI)
  • Documented coronary artery disease defined by at least one of the following:

    -≥ 50% stenosis of coronary artery on angiography or other imaging modality.

  • Ischaemia documented by stress test with any imaging modality.
  • Prior unstable angina with electrocardiogram (ECG) changes.
  • Prior coronary artery bypass graft or prior percutaneous coronary intervention.
  • Prior stroke (ischemic or haemorrhagic stroke).
  • History of chronic kidney disease based on medical records or as judged by the investigator as determined by central laboratory at screening.
  • Symptomatic peripheral arterial disease (PAD) defined as at least one of the following:
  • Intermittent claudication with an ankle-brachial index (ABI) < 0.85 at rest.
  • Intermittent claudication with a ≥ 50% stenosis in a lower extremity peripheral artery documented by X-ray angiography, magnetic resonance (MR) angiography, computer tomography (CT) angiography or Doppler ultrasound.
  • Prior revascularisation procedure of a lower extremity peripheral artery.
  • Lower extremity amputation at or above ankle due to atherosclerotic disease (excluding e.g., trauma or osteomyelitis)

Exclusion Criteria:

  • Myocardial infarction, stroke, transient ischaemic attack or hospitalisation for unstable angina pectoris within 60 days before screening.
  • Planned coronary, carotid or peripheral artery revascularisation.
  • Chronic or intermittent haemodialysis or peritoneal dialysis within 90 days before screening.

Diabetes- or weight related:

  • Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria before screening. However, insulin treatment for gestational diabetes is allowed as well as short term insulin treatment for a maximum of 14 consecutive days.
  • Treatment with glucagon-like-peptide-1 (GLP-1) receptor agonists (RA), dual GLP1/gastric inhibitory peptide (GIP) RAs (or any other GLP-1 based treatment), dipeptidyl peptidase 4 (DPP-4) inhibitors or amylin analogues before screening.
  • Participant with diabetic retinopathy or maculopathy who received treatment with retinal photocoagulation, vitrectomy or anti-Vascular Endothelial Growth Factor (anti-VEGF) within 180 days before screening or are expected to require treatment within 180 days after screening. Diabetic retinopathy or maculopathy must be verified by an eye examination performed 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.
  • Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire question.
  • Any episodes of diabetic ketoacidosis before screening.
  • Uncontrolled thyroid disease as per investigator's discretion.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Zenagamtide
Participants will receive zenagamtide subcutaneously once weekly to one of the body parts: thigh, abdomen or upper arm.
Zenagamtide will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm (administration to the same body part throughout the study).
Aktiv komparator: Insulin glargine U-100
Participants will receive Insulin glargine U-100 subcutaneously once daily to one of the body parts: thigh, abdomen or upper arm.
Insulin glargine U-100 will be administered subcutaneously using SoloSTAR pen-injector to one of the body parts: thigh, abdomen or upper arm (rotation of the injection site within body parts).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Non-inferiority of zenagamtide versus insulin glargine: change in haemoglobin A1c (HbA1c)
Tidsramme: From baseline (week 0) to week 52
Measured as percentage (%)-points
From baseline (week 0) to week 52

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time to first occurrence of a 4-point major adverse cardiovascular events (MACE) endpoint consisting of: Cardiovascular (CV) death, non-fatal myocardial infarction, non-fatal stroke and hospitalisation for unstable angina
Tidsramme: From baseline (week 0) to 104 weeks or more
Measured as days
From baseline (week 0) to 104 weeks or more
Relative change in body weight
Tidsramme: From baseline (week 0) to week 52
Measured as percentage (%) change
From baseline (week 0) to week 52
Superiority of zenagamtide versus insulin: Change in HbA1c
Tidsramme: From baseline (week 0) to week 52
Measured as %-points
From baseline (week 0) to week 52
Time to first occurrence of a 3-point MACE endpoint consisting of: CV death, non-fatal myocardial infarction and non-fatal stroke
Tidsramme: From baseline (week 0) to 104 weeks or more
Measured as Days
From baseline (week 0) to 104 weeks or more
Change in waist circumference
Tidsramme: From baseline (week 0) to week 52
Measured as centimeters
From baseline (week 0) to week 52
Change in systolic blood pressure
Tidsramme: From baseline (week 0) to week 52
Measured as millimeters of mercury (mmHg)
From baseline (week 0) to week 52
Change in high-sensitivity C-reactive protein (hsCRP)
Tidsramme: From baseline (week 0) to week 52
Measured as ratio to baseline
From baseline (week 0) to week 52
Change in Triglycerides
Tidsramme: From baseline (week 0) to week 52
Measured as ratio to baseline
From baseline (week 0) to week 52
Change in Non-high-density lipoprotein (non-HDL) cholesterol
Tidsramme: From baseline (week 0) to week 52
Measured as ratio to baseline
From baseline (week 0) to week 52

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

24. august 2026

Primær færdiggørelse (Anslået)

31. juli 2028

Studieafslutning (Anslået)

20. september 2028

Datoer for studieregistrering

Først indsendt

26. august 2026

Først indsendt, der opfyldte QC-kriterier

26. august 2026

Først opslået (Faktiske)

1. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • NN9490-8665
  • U1111-1333-6446 (Anden identifikator: UTN Number)
  • 2026-525209-11 (Anden identifikator: European Medical Agency (EMA))

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

According to the Novo Nordisk disclosure commitment on novonordisktrials.com

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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