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NCT06065540CompletedPhase 3

A Research Study to See How Well CagriSema Compared to Semaglutide, Cagrilintide and Placebo Lowers Blood Sugar and Body Weight in People With Type 2 Diabetes Treated With Metformin With or Without an SGLT2 Inhibitor

Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) s.c. in Doses 2.4/2.4 mg and 1.0/1.0 mg Once Weekly Versus Semaglutide 2.4 mg and 1.0 mg, Cagrilintide 2.4 mg and Placebo in Participants With Type 2 Diabetes Inadequately Controlled on Metformin With or Without an SGLT2 Inhibitor

Source: ClinicalTrials.gov · Last updated 8 Jul 2026

Brief summary (registry, in English)

The study will look at how well CagriSema helps people lower their blood sugar and body weight. CagriSema is a new weekly medicine that combines two medicines called semaglutide and cagrilintide. CagriSema will be compared to the two medicines semaglutide and cagrilintide, when they are taken alone. CagriSema will also be compared to a "dummy" medicine without any active ingredient. The study will be done in participants who have type 2 diabetes. Participants will take the study medicine together with the current diabetes medicine (metformin with or without an SGLT2 inhibitor).

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
2734 (actual)
First submitted
26 Sept 2023
Start date
27 Sept 2023
Primary completion date
19 Nov 2025
Lead sponsor
Novo Nordisk A/S
NCT number
NCT06065540
EU CT number
2022-502678-18-00
EudraCT number
2022-502678-18

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 2734
  • From 27 Sept 2023 to the primary completion date, 19 Nov 2025
  • 389 sites in 32 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are allowed.
  • Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by an eye examination performed within 90 days before screening or in the period between screening and randomisation.

Lab values

  • Renal impairment with estimated Glomerular Filtration Rate (eGFR) less than 30 milliliters per minute per 1.73 square metre (mL/min/1.73 m\^2) as determined by central laboratory at screening.

Who the study is looking for

  • Male or female (sex at birth).
  • Age 18 years or above at the time of signing the informed consent.
  • Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days before screening.
  • Stable daily dose(s) greater than or equal to 90 days before screening of any of the following antidiabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose as judged by the investigator: metformin with or without Sodium-Glucose Cotransporter-2 (SGLT2) inhibitors.
  • Glycated haemoglobin (HbA1c) 7.0-10.5 percent (53-91 millimoles per mole \[mmol/mol\]) (both inclusive) as determined by central laboratory at screening.
  • Body Mass Index (BMI) greater than or equal to 25 kilogram per square metre ( kg/m\^2) at screening. BMI will be calculated in the electronic case report form (eCRF) based on height and body weight at screening.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (389)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli
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Buenos AiresArgentinaUnknown status
STAT Research
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Buenos AiresArgentinaUnknown status
CIPREC Arenales
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CABAArgentinaUnknown status
Sanatorio Guemes
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CABAArgentinaUnknown status
Mautalen- Salud e Investigacion
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CABAArgentinaUnknown status
Instituto de Investigaciones Clinicas Rosario
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RosarioArgentinaUnknown status
Charles Perkins Centre
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CamperdownAustraliaUnknown status
Momentum Clinical Research Darlinghurst
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DarlinghurstAustraliaUnknown status
St Vincent's Hospital Melbourne - Endocrinology & Diabetes Department
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FitzroyAustraliaUnknown status
Macquarie University - Clinical Trials Unit
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Macquarie ParkAustraliaUnknown status
Logan Hospital
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MeadowbrookAustraliaUnknown status
Baker Heart and Diabetes Institute
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MelbourneAustraliaUnknown status
Hunter Diabetes Centre
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MerewetherAustraliaUnknown status
Southern Adelaide Diabetes & Endocrine Services
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Oaklands ParkAustraliaUnknown status
Individual Practice For Specialized Medical Care Dr. Nikolay Kostadinov EOOD
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BurgasBulgariaCompleted
Dr. Tatyana Metalova Ambulatoria Za Individualna Praktika Za Spetsializirana Meditsinska EOOD
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Gotse DelchevBulgariaCompleted
Medical Center Zdrave Lom EOOD
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LomBulgariaCompleted
Razgrad Medical Center Ltd.
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RazgradBulgariaCompleted
Diagnostic Consultative Centre Ascendent OOD
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SofiaBulgariaCompleted
Medical Center Maria Med EOOD
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SofiyaBulgariaCompleted
MBAL Sveta Marina EAD
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VarnaBulgariaCompleted
Medcenter Nova Clinic Ltd.
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VarnaBulgariaCompleted
Cline Research Center
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CuritibaBrazilUnknown status
CPCLIN - Centro de Pesquisas Clínicas
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São PauloBrazilUnknown status
CPQuali Pesquisa Clínica Ltda
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São PauloBrazilUnknown status
Centricity Res. Barrie Endo
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BarrieCanadaUnknown status
Centricity Research Brampton Endocrinology
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BramptonCanadaUnknown status
Centricity Research Calgary Endocrinology
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CalgaryCanadaUnknown status
Centricity Research Calgary
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CalgaryCanadaUnknown status
Centricity Research Vaughn Endocrinology
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ConcordCanadaUnknown status
Medical Trust Clinics, Inc.
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CourticeCanadaUnknown status
Centricity Research Etobicoke Endocrinology
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EtobicokeCanadaUnknown status
Milestone Research
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LondonCanadaUnknown status
Western Univ. Cnt for Studies in Fam Med
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LondonCanadaUnknown status
My Endo Diabetes & Endo Cent
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MarkhamCanadaUnknown status
G.A. Research Associates, Ltd.
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MonctonCanadaUnknown status
Centre Medical Acadie
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MontrealCanadaUnknown status
Centricity Research Ottawa LMC
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NepeanCanadaUnknown status
Centricity Research Oshawa
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OshawaCanadaUnknown status
Centricity Res Pointe-Claire
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Pointe-ClaireCanadaUnknown status
Centre de Recherche Saint-Louis
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QuébecCanadaUnknown status
Alpha Recherche Clinique
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QuébecCanadaUnknown status
Clinique des Maladies Lipidiques de Quebec Inc.
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QuébecCanadaUnknown status
Diex Recherche Québec
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QuébecCanadaUnknown status
LMC Clin Rsrch Inc. (Montreal)
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Saint-LaurentCanadaUnknown status
Q&T Research Sherbrooke Inc.
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SherbrookeCanadaUnknown status
Synergy Wellness Clinic
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Sherwood ParkCanadaUnknown status
TLC Diabetes and Endocrinology
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SurreyCanadaUnknown status
Ocean West Research Clinic
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SurreyCanadaUnknown status
Hilltop Medical Clinic
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SurreyCanadaUnknown status
Guilford Med Clinic
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SurreyCanadaUnknown status
Ctr de Med Metab de Lanaudiere
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TerrebonneCanadaUnknown status
Centricity Research Toronto
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TorontoCanadaUnknown status
Diabetes Heart Research Centre
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TorontoCanadaUnknown status
Spectrum Health Clinic
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VancouverCanadaUnknown status
Diex Recherche Victoriaville
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VictoriavilleCanadaUnknown status
Chinese People's Liberation Army General Hospital-Endocrinology
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BeijingChinaUnknown status
Beijing Friendship Hospital, Capital Medical University-Endocrinology
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BeijingChinaUnknown status
Chongqing University Three Gorges Hospital
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ChongqingChinaUnknown status
Jinan Central Hospital
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Ji'nanChinaUnknown status
Jinan Central Hospital
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JinanChinaUnknown status
Huaihe Hospital of Henan University-Endocrinology
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KaifengChinaUnknown status
The Second Affiliated Hospital of Nanjing Medical University-Endocrinology
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NanjingChinaUnknown status
Suzhou Municipal Hospital-Endocrinology
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SuzhouChinaUnknown status
The Affiliated Hospital of Jiangsu University-Endocrinology
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ZhenjiangChinaUnknown status
Cimedical
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BarranquillaColombiaUnknown status
Clinica Imbanco SAS
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CaliColombiaUnknown status
FOSCAL
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FloridablancaColombiaUnknown status
IMAT - Oncomedica
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MonteríaColombiaUnknown status
Fakultni Nemocnice U Sv Anny V Brne
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Brno-StredCzechiaCompleted
Edumed s.r.o.
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BroumovCzechiaCompleted
Diahaza s.r.o.
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HolešovCzechiaCompleted
DIALINE s.r.o.
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Plzeň 3CzechiaCompleted
Diabet2 s.r.o.
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Prague 1CzechiaCompleted
MUDr. Michala Pelikanova s.r.o.
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Prague 4CzechiaCompleted
Institut Klinicke A Experimentalni Mediciny
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Prague 4CzechiaCompleted
Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR
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BerlinGermanyCompleted
Diabetologische Schwerpunktpraxis Daaden
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DaadenGermanyCompleted
Diabeteszentrum-Do Dres. K U. Ch. Busch GbR
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DortmundGermanyCompleted
Technische Universität Dresden
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DresdenGermanyCompleted
Zentrum fuer klinische Studien Suedbrandenburg GmbH
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ElsterwerdaGermanyCompleted
InnoDiab Forschung Gmbh
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EssenGermanyCompleted
BAG Diabeteszentrum Dr. Tews & Partner
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GelnhausenGermanyCompleted
Diabetes Zentrum Wandsbek Diabetologische Schwerpunktpraxis Berufsausuebungsgemeinschaft GbR
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HamburgGermanyCompleted
Diabetes Zentrum Wilhelmsburg GbR
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HamburgGermanyCompleted
Diabetologische Gemeinschaftspraxis Dr. Staudenmeyer und Dr. Schiwietz
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LingenGermanyCompleted
University of Luebeck
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LübeckGermanyCompleted
Die Praxis am Ludwigsplatz
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LudwigshafenGermanyCompleted
Medicover Neuroendokrinologie MVZ
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MuenchenGermanyCompleted
R.E.D. Institut fuer medizinische Studien und Fortbildung GmbH
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Oldenburg in HolsteinGermanyCompleted
Praxis Fuer Innere Medizin
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ZwenkauGermanyCompleted
Aarhus Universitetshospital
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AarhusDenmarkCompleted
Bispebjerg Hospital
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CopenhagenDenmarkCompleted
Steno Diabetes Center Copenhagen
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HerlevDenmarkCompleted
Nordsjaellands Hospital
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HilleroedDenmarkCompleted
Hvidovre Hospital
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HvidovreDenmarkCompleted
Odense University Hospital
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Odense CDenmarkCompleted
Complexo Hospitalario Universitario A Coruña
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A CoruñaSpainCompleted
Vall D'hebron Institut De Recerca
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BarcelonaSpainCompleted
Projectes Sanitaris I Socials S.A.
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La Roca Del VallesSpainCompleted
Hospital Universitario De Móstoles
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MóstolesSpainCompleted
Hospital General de Segovia
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SegoviaSpainCompleted
Hospital Quironsalud Infanta Luisa
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SevillaSpainCompleted
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainCompleted
Suomen Terveystalo Oy
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JyvaskylaFinlandCompleted
Etela-Pohjanmaan Sairaanhoitopiiri
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SeinajokiFinlandCompleted
Suomen Terveystalo Oy
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TampereFinlandCompleted
Pihlajalinna Laeaekaerikeskukset Oy
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TampereFinlandCompleted
Turku University Hospital
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TurkuFinlandCompleted
Aberdeen Royal Infirmary
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AberdeenUnited KingdomUnknown status
Aberdeen Royal Infirmary - Diabetes
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AberdeenUnited KingdomUnknown status
Oldfield Surgery
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BathUnited KingdomUnknown status
Oakenhurst Medical Practice
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BlackburnUnited KingdomUnknown status
Ninewells Hospital
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DundeeUnited KingdomUnknown status
Aintree University Hospital
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LiverpoolUnited KingdomUnknown status
Norfolk and Norwich University Hospital Trust
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NorwichUnited KingdomUnknown status
Pickering Medical Practice
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PickeringUnited KingdomUnknown status
Moorgreen Hospital
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SouthamptonUnited KingdomUnknown status
Lister Hospital
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StevenageUnited KingdomUnknown status
Joint Clinical Research Facility - Swansea
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SwanseaUnited KingdomUnknown status
Royal Cornwall Hospital (Treliske)
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TruroUnited KingdomUnknown status
Laiko General Hospital of Athens
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AthensGreeceCompleted
General Hospital of Athens "G. Gennimatas"
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AthensGreeceCompleted
University General Hospital Attikon
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AthensGreeceCompleted
Athens Medical Center S.A.
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AthensGreeceCompleted
General Hospital Of Thessaloniki Papageorgiou
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EfkarpiaGreeceCompleted
General University Hospital of Larissa
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LarissaGreeceCompleted
Athens Medical Center S.A.
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MaroussiGreeceCompleted
Hippokration Hospital
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ThessalonikiGreeceCompleted
University General Hospital of Thessaloniki - AHEPA
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ThessalonikiGreeceCompleted
Euromedica General Clinic of Thessaloniki
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ThessalonikiGreeceCompleted
Poliklinika Solmed d.o.o.
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Grad ZagrebCroatiaCompleted
Thalassotherapia Specijalna bolnica za medicinsku rehabilitaciju bolesti srca pluca i reumatizma
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OpatijaCroatiaCompleted
Poliklinika SLAVONIJA OSIJEK za opcu kirurgiju radiologiju baromedicinu ginekologiju i porodiljstvo i internu medicinu
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OsijekCroatiaCompleted
Clinical Hospital Centre Rijeka
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RijekaCroatiaCompleted
General Hospital Dr. Josip Bencevic
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Slavonski BrodCroatiaCompleted
Opca Bolnica Varazdin
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VarazdinCroatiaCompleted
Bajcsy-Zsilinszky Korhaz es Rendelointezet
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BudapestHungaryCompleted
Obudai Egeszsegugyi Centrum Kft.
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Budapest IIIHungaryCompleted
Central Hospital Of Northern Pest Military Hospital
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Budapest XIIIHungaryCompleted
University of Debrecen
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DebrecenHungaryCompleted
Somogy Vármegyei Kaposi Mór Oktató Kórház
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KaposvárHungaryCompleted
Kanizsai Dorottya Korhaz
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NagykanizsaHungaryCompleted
University of Szeged
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SzegedHungaryCompleted
University Teaching Hospital Markusovszky
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SzombathelyHungaryCompleted
Zala Megyei Szent Rafael Korhaz
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ZalaegerszegHungaryCompleted
Linn clinic - Clalit Health Services
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HaifaIsraelUnknown status
Linn clinic - Diabetes Unit
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HaifaIsraelUnknown status
Clalit sick fund Herzeliya
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HerzeliyaIsraelUnknown status
Clalit sick fund Herzlia
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HerzliyaIsraelUnknown status
Wolfson MC - Diabetes Clinic
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HolonIsraelUnknown status
Hadassah Ein Karam MC - Diabetes Unit
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JerusalemIsraelUnknown status
Kaplan MC - Metabolic Unit
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RehovotIsraelUnknown status
Kaplan MC
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RehovotIsraelUnknown status
Sheba MC - Endocrinology Clinic
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Tel HaShomerIsraelUnknown status
Swasthya Diabetes Care
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AhmedabadIndiaUnknown status
Lifecare Hospital and Research Centre
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BengaluruIndiaUnknown status
Post Graduate Institute of Medical Education & Research,
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ChandigarhIndiaUnknown status
Madras Diabetes Research Foundation
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ChennaiIndiaUnknown status
KG Hospital
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CoimbatoreIndiaUnknown status
Gauhati Medical college and Hospital
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GuwahatiIndiaUnknown status
Gleneagles Hospitals
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HyderabadIndiaUnknown status
Dr P V Rao - Diabetes Research Centre
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HyderabadIndiaUnknown status
SMS Medical College & Hospital
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JaipurIndiaUnknown status
Apollo Multispeciality Hospital, Kolkata
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KolkataIndiaUnknown status
BYL Nair Hospital and T N Medical College Department of endo
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MumbaiIndiaUnknown status
K R Hospital
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MysuruIndiaUnknown status
Lady Hardinge Medical College
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New DelhiIndiaUnknown status
Ashirwad Hospital and Research Centre
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ThaneIndiaUnknown status
Yalamanchi Hospitals and Research centres pvt ltd
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VijaywadaIndiaUnknown status
Azienda Sanitaria Usl Toscana Sud Est
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ArezzoItalyCompleted
Azienda Ospedaliera Papa Giovanni XXIII
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BergamoItalyCompleted
Azienda Ospedaliero Universitaria Renato Dulbecco
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CatanzaroItalyCompleted
Universita' Degli Studi G. D'annunzio Di Chieti
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ChietiItalyCompleted
Careggi University Hospital
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FlorenceItalyCompleted
Ospedale San Raffaele S.r.l.
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MilanItalyCompleted
ASST Fatebenefratelli Sacco
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MilanItalyCompleted
Azienda Ospedaliera Universitaria Federico II Di Napoli
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NaplesItalyCompleted
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
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PalermoItalyCompleted
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyCompleted
Azienda Ospealiero Universitaria Policlinico Umberto I
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RomeItalyCompleted
Azienda Ospedaliera Universitaria Integrata Verona
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VeronaItalyCompleted
Akaicho Clinic
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Chiba-shi, ChibaJapanUnknown status
Naka Kinen Clinic
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IbarakiJapanUnknown status
Naka Kinen Clinic_Internal medicine
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IbarakiJapanUnknown status
Seino Internal Medicine Clinic_Internal medicine
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Koriyama-shi, FukushimaJapanUnknown status
Minami Akatsuka Clinic_internal medicine
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Mito-shi, IbarakiJapanUnknown status
Abe Diabetes Clinic_Internal Medicine
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Oita-shi, Oita,JapanUnknown status
Medical Research Institute KITANO HOSPITAL_Diabetes & Endocrinology
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Osaka-shi, OsakaJapanUnknown status
Tokyo-Eki Center-building Clinic_Internal Medicine
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TokyoJapanUnknown status
Fukuwa Clinic_Internal Medicine
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TokyoJapanUnknown status
Fukuwa Clinic
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TokyoJapanUnknown status
The Catholic University of Korea, Bucheon St. Mary's Hospital
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Bucheon-siSouth KoreaUnknown status
Yeungnam University Medical Center
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DaeguSouth KoreaUnknown status
Chosun University Hospital
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GwangjuSouth KoreaUnknown status
KyungHee University Medical Center
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SeoulSouth KoreaUnknown status
Korea University Anam Hospital
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SeoulSouth KoreaUnknown status
Seoul National University Hospital
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SeoulSouth KoreaUnknown status
Kangbuk Samsung Hospital
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SeoulSouth KoreaUnknown status
Centro de Estudios de Investigación Metabólicos y Cardio
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Ciudad MaderoMexicoUnknown status
Instituto Jalisciense de Investigacion en Diabetes y Obesidad
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GuadalajaraMexicoUnknown status
Centro de Investigacion Clinica Endocrinologica de Jalisco
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GuadalajaraMexicoUnknown status
Centro de investigación en Artritis y Osteoporosis S.C.
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MexicaliMexicoUnknown status
Niepublicznego Zakladu Opieki Zdrowotnej Specjalistyczny Osrodek Internistyczno Diabetologiczny
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BialystokPolandCompleted
NZOZ Osteo-Medic S.C
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BiałystokPolandCompleted
Pratia S.A.
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BydgoszczPolandCompleted
American Heart of Poland S.A.
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ChrzanówPolandCompleted
American Heart of Poland S.A.
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Dąbrowa GórniczaPolandCompleted
Specjalistyczny Gabinet Diabetologiczny Radosław Rumianowski
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Gorzów WielkopolskiPolandCompleted
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
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LodzPolandCompleted
Velocity Nova Sp. z o.o.
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LublinPolandCompleted
Centrum Medyczne Medyk Sp. z o.o.
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RzeszowPolandCompleted
Velocity Nova Sp. z o.o.
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StaszowPolandCompleted
American Heart of Poland S.A.
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TychyPolandCompleted
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji
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WarsawPolandCompleted
Nbr Polska Tomasz Klodawski
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WarsawPolandCompleted
Instytut Diabetologii.sp.z.o.o.
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WarsawPolandCompleted
American Heart of Poland S.A.
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ZgierzPolandCompleted
Prywatna Praktyka Lekarska Anna Chudoba
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ŻyrardówPolandCompleted
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BacauRomaniaCompleted
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