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NCT03811561Active, not recruitingPhase 3

A Research Study to Look at How Semaglutide Compared to Placebo Affects Diabetic Eye Disease in People With Type 2 Diabetes

Long-term Effects of Semaglutide on Diabetic Retinopathy in Subjects With Type 2 Diabetes

Source: ClinicalTrials.gov · Last updated 7 Oct 2026

Brief summary (registry, in English)

This study will look at the long-term effects of semaglutide (active medicine) on diabetic eye disease when compared to placebo (dummy medicine). The study will be performed in people with type 2 diabetes. Participants will either get semaglutide or placebo in addition to their diabetes medicines - which treatment the participant gets is decided by chance. Participants will inject the study medicine using a pen-injector. The medicine must be injected in a skin fold in the stomach, thigh or upper arm once a week. The study will last for 5 years.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
1500 (estimated)
First submitted
18 Jan 2019
Start date
8 May 2019
Primary completion date
7 Nov 2027
Lead sponsor
Novo Nordisk A/S
NCT number
NCT03811561
EU CT number
2023-506827-26-00
EudraCT number
2017-003619-20

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 1500
  • From 8 May 2019 to the primary completion date, 7 Nov 2027
  • 208 sites in 19 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

  • Any of the following: myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within the past 60 days prior to the day of screening
  • Concurrent treatment with any GLP-1 receptor agonist or DPP-4 inhibitor from randomisation.
  • Receipt of any investigational medicinal product within 30 days before screening
  • Previous participation in this trial. Participation is defined as randomisation

Other illness

  • Subjects presently classified as being in New York Heart Association (NYHA) Class IV
  • Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma
  • Presence or history of malignant neoplasms within the past 5 years prior to the day of screening. Basal and squamous cell skin cancer and any carcinoma in-situ are allowed
  • Known or suspected hypersensitivity to trial products or related products
  • Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol

Lab values

  • Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of eGFR less than 30 ml/min/1.73 m\^2

Other

  • Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
  • Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using highly effective contraceptive methods

Who the study is looking for

  • Male or female, age greater than or equal to 18 years at the time of signing informed consent
  • Diagnosed with type 2 diabetes mellitus.
  • HbA1c of 7.0-10.0% (53-86 mmol/mol) (both inclusive).
  • Eye inclusion criteria (both eyes must meet all criteria):
  • Early Treatment Diabetic Retinopathy Study (ETDRS) level of 10-75 (both inclusive) evaluated by fundus photography and confirmed by central reading centre
  • No ocular or intraocular treatment for diabetic retinopathy or diabetic macular oedema six months prior to the day of screening.
  • No anticipated need for ocular or intraocular treatment for diabetic retinopathy or diabetic macular oedema within three months after randomisation.
  • Best-corrected visual acuity greater than or equal to 30 letters using the ETDRS visual acuity protocol
  • No previous treatment with pan-retinal laser photocoagulation
  • No substantial non-diabetic ocular condition that, in the opinion of the ophthalmologist, would impact diabetic retinopathy or diabetic macular oedema progression during the trial
  • No substantial media opacities that would preclude successful imaging

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

Full criteria on ClinicalTrials.gov

Sites (208)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
MBAL Sveti Pantaleimon OOD
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PlevenBulgariaActive, not recruiting
Diagnostic-Consultative Center I Pleven EOOD
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PlevenBulgariaActive, not recruiting
University Multiprofile Hospital For Active Treatment Saint Georgi EAD
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PlovdivBulgariaActive, not recruiting
MBAL Med Line Clinic AD
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PlovdivBulgariaActive, not recruiting
Multiprofile Hospital For Active Treatment Medical Complex Sveti Ivan Rilski EOOD
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PlovdivBulgariaActive, not recruiting
Diagnostic Consultation Center XX-Sofia EOOD
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SofiaBulgariaActive, not recruiting
Fourth Multiprofile Hospital For Active Treatment-Sofia EAD
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SofiaBulgariaActive, not recruiting
Diagnostic Consulting Center VII-Sofia EOOD
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SofiaBulgariaActive, not recruiting
Meditsinski Tsentar Vitklinik EOOD
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SofiaBulgariaActive, not recruiting
Multiprofile Hospital For Active Treatment Knyaginya Klementina Sofia EAD
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SofiyaBulgariaActive, not recruiting
University Specialized Hospital For Active Treatment In Endocrinology Akad. Iv. Penchev EAD
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SofiyaBulgariaActive, not recruiting
CPQuali Pesquisa Clínica Ltda
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São PauloBrazilUnknown status
LMC Clinical Res Thornhill
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ConcordCanadaUnknown status
Alberta Diabetes Institute
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EdmontonCanadaUnknown status
LMC Endo Ctr (Etobicoke) Ltd
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EtobicokeCanadaUnknown status
LMC Clinical Research, Inc. (Montreal Glen)
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MontrealCanadaUnknown status
LMC Oakville
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OakvilleCanadaUnknown status
The Ottawa Hospital - Riverside Campus
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OttawaCanadaUnknown status
Centricity Res Pointe-Claire
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Pointe-ClaireCanadaUnknown status
LMC Clin Rsrch Inc. (Montreal)
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Saint-LaurentCanadaUnknown status
LMC Endo Centres Ltd.(Bayview)
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TorontoCanadaUnknown status
Fakultni nemocnice Brno
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BrnoCzechiaCompleted
Fakultni Nemocnice Hradec Kralove
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Novy Hradec KraloveCzechiaCompleted
Institute for Clinical and Experimental Medicine
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PragueCzechiaCompleted
Diainmed s.r.o.
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PragueCzechiaCompleted
Fakultní Nemocnice Královské Vinohrady
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Prague 10CzechiaCompleted
MUDr. Michala Pelikanova s.r.o.
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Prague 4CzechiaCompleted
Wendisch/Dahl Hamburg
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HamburgGermanyActive, not recruiting
Diabetes Zentrum Wilhelmsburg GbR
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HamburgGermanyActive, not recruiting
Institut fuer Diabetesforschung Muenster GmbH
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MuensterGermanyActive, not recruiting
Praxis Dr. med. Wenzl-Bauer
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Rehlingen-SiersburgGermanyActive, not recruiting
Schwerpunktpraxis für Diabetes und Ernährungsmedizin
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-GermanyActive, not recruiting
Complexo Hospitalario Universitario A Coruña
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A CoruñaSpainCompleted
Hospital Universitari Vall d'Hebron
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BarcelonaSpainCompleted
Bellvitge University Hospital
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L'hospitalet De LlobregatSpainCompleted
Clínica Universidad de navarra
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PamplonaSpainCompleted
Hospital Universitario Virgen De La Macarena
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SevillaSpainCompleted
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainCompleted
Harrogate District Hospital
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HarrogateUnited KingdomUnknown status
King's College Hospital
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LondonUnited KingdomUnknown status
Norfolk and Norwich University Hospital
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NorfolkUnited KingdomUnknown status
Queen's Medical Centre University Hospital
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NottinghamUnited KingdomUnknown status
University Hospital, Queens Medical Centre
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NottinghamUnited KingdomUnknown status
George Eliot Hospital NHS Trust
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NuneatonUnited KingdomUnknown status
George Eliot Hospital
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NuneatonUnited KingdomUnknown status
Clinical Research Unit
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SomersetUnited KingdomUnknown status
Royal Cornwall Hospital (Treliske)
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TruroUnited KingdomUnknown status
Yeovil Hospital
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YeovilUnited KingdomUnknown status
Laiko General Hospital of Athens
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AthensGreeceActive, not recruiting
Athens Medical Center S.A.
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AthensGreeceActive, not recruiting
University General Hospital Attikon
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AthensGreeceActive, not recruiting
Thermi Clinic S.A.
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ThessalonikiGreeceActive, not recruiting
Hippokration Hospital
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ThessalonikiGreeceActive, not recruiting
Rambam MC - Diabetes and obesity center of excellence
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HaifaIsraelUnknown status
Hadassah Ein Karam MC - Diabetes Unit
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JerusalemIsraelUnknown status
Meir MC - Diabetes unit
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Kfar SabaIsraelUnknown status
Rabin MC Beilinson - Endo unit
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Petah TikvaIsraelUnknown status
Sourasky MC - Institute of Endocrinology, metabolism and hypertension
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Tel AvivIsraelUnknown status
Sheba MC - Endocrinology Clinic
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Tel HaShomerIsraelUnknown status
All India Institute of Medical Sciences
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Ansari Nagar, New Delhi 110029IndiaUnknown status
Narayana Hrudayalya Institute of Cardiac Sciences
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BangaloreIndiaUnknown status
Diacon Hospital Private Limited
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BangaloreIndiaUnknown status
Madras Diabetes Research Foundation
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ChennaiIndiaUnknown status
Apollo Hospital
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DelhiIndiaUnknown status
Indraprastha Apollo Hospital
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DelhiIndiaUnknown status
Endolife Specialty Hospitals
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GunturIndiaUnknown status
Care Hospital
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HyderabadIndiaUnknown status
Amrita Institute of Medical Sciences & Research Centre
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KochiIndiaUnknown status
SSKM
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KolkataIndiaUnknown status
Apollo Gleneagles Hospital
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KolkataIndiaUnknown status
Apollo Multispeciality Hospital, Kolkata
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KolkataIndiaUnknown status
Dayanand Medical College & Hospital_Ludhiana
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LudhianaIndiaUnknown status
Christian Medical College and Hospital
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LudhianaIndiaUnknown status
Arthur Asirvatham hospital,
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MaduraiIndiaUnknown status
Aditya Jyot Hospital
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MumbaiIndiaUnknown status
Seth GS medical college and KEM Hospital
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MumbaiIndiaUnknown status
BYL Nair Hospital and T N Medical College Department of endo
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MumbaiIndiaUnknown status
Government Medical College and Super Speciality Hospital, Nagpur
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NagpurIndiaUnknown status
DEW Medicare & Trinity hospital
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NagpurIndiaUnknown status
All India Institute of Medical Sciences
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New DehliIndiaUnknown status
Deenanath Mangeshkar Hospital & Research Centre
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PuneIndiaUnknown status
Nirmal Hospital Pvt Ltd.
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SuratIndiaUnknown status
Indian Institute of Diabetes
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ThiruvananthapuramIndiaUnknown status
Indian Institute of Diabetes
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ThiruvnanthapuramIndiaUnknown status
Zemgales diabeta centrs SIA
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JelgavaLatviaActive, not recruiting
Daces Teterovskas arsta prakse endokrinologija SIA
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OgreLatviaActive, not recruiting
Pauls Stradins Clinical University Hospital
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RigaLatviaActive, not recruiting
Veselibas centru apvieniba AS
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RigaLatviaActive, not recruiting
Instituto Nacional de Nutricion - Unidad de Inv de Enf Metab
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Distrito FederalMexicoUnknown status
Hospital Universitario Dr. José Eleuterio González_Monterrey
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MonterreyMexicoUnknown status
Uniwersytecki Szpital Kliniczny w Bialymstoku
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BialystokPolandActive, not recruiting
In- Vivo Sp. z o. o.
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BydgoszczPolandActive, not recruiting
Futuremeds Sp. z o.o.
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CracowPolandActive, not recruiting
Gdanska Poradnia Cukrzycowa Sp. z o.o.
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GdanskPolandActive, not recruiting
Synexus Polska Sp z o.o.
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GdanskPolandActive, not recruiting
Pratia S.A.
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KatowicePolandActive, not recruiting
Prywatny Gabinet Lekarski Jan Ruxer
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LodzPolandActive, not recruiting
Santa SP. z o.o
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LodzPolandActive, not recruiting
Gaja Poradnie Lekarskie Maciej Wiza
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PoznanPolandActive, not recruiting
NZOZ "DiabMed" Poradnia Diabetologiczna
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PoznanPolandActive, not recruiting
Samodzielny Publiczny Szpital Kliniczny Nr 1 Im.Prof.Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego W Katowicach
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ZabrzePolandActive, not recruiting
Hospital Garcia De Orta E.P.E.
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AlmadaPortugalActive, not recruiting
Centro Hospitalar Do Baixo Vouga E.P.E. (CHBV E.P.E.)
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AveiroPortugalActive, not recruiting
Centro Hospitalar E Universitărio de Coimbra E.P.E.
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CoimbraPortugalActive, not recruiting
Hospital da Senhora da Oliveira Guimarães, E.P.E.
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GuimarãesPortugalActive, not recruiting
APDP - Associação Protectora dos Diabéticos de Portugal
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LisbonPortugalActive, not recruiting
Centro Hospitalar Universitario Sao Joao E.P.E.
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PortoPortugalActive, not recruiting
Unidade Local De Saude De Matosinhos E.P.E.
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Senhora Da HoraPortugalActive, not recruiting
Unidade Local de Saude da Arrabida E. P. E
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SetúbalPortugalActive, not recruiting
Clinica Diabnutrimed S.R.L.
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BucharestRomaniaActive, not recruiting
Spitalul Universitar de Urgenta Militar Central 'Dr. Carol Davila'
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BucharestRomaniaActive, not recruiting
Institutul National De Diabet Nutritie Si Boli Metabolice Prof.Dr.N.Paulescu Bucuresti
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BucharestRomaniaActive, not recruiting
Spitalul Clinic Judetean De Urgenta Cluj
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Cluj-NapocaRomaniaActive, not recruiting
Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara
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TimisoaraRomaniaActive, not recruiting
Endocrinology, Diabetes and Metabolism Diseases Clinic
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BelgradeSerbiaUnknown status
CHC Zvezdara, Clinical department for endocrinology
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BelgradeSerbiaUnknown status
Clinical hospital center Bezanijska Kosa
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BelgradeSerbiaUnknown status
Clinical Centre Nis, Endocrinology, Diabetes and Metabolism
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NišSerbiaUnknown status
Clin. Centre Vojvodina, Clin. endocr., diab. and met. dis.
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Novi SadSerbiaUnknown status
Multispecialty Medical Clinic Anturium LLC
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BarnaulRussiaUnknown status
Kazan Federal University
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Kazan'RussiaUnknown status
PIH "Clin Hosp "RZD-Medicina" former Kazan OJSC Rus Railways
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Kazan'RussiaUnknown status
FSBI 'I.I. Dedov National Medical Research Center of Endocrinology' of the MH of Russia
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MoscowRussiaUnknown status
National Medical Research Center of Endocrinology
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MoscowRussiaUnknown status
Branch of limited liability company "Hadassah Medical LTD"
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MoscowRussiaUnknown status
State Novosibirsk Regional Clinical Hospital
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NovosibirskRussiaUnknown status
Llc "International Medical Center "Time"
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Saint-PeterburgRussiaUnknown status
Diagnistic Centre "Energo"
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Saint PetersburgRussiaUnknown status
Consultative & Diagnostic Center with a Outpatient Hospital
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Saint PetersburgRussiaUnknown status
City Consultative & Diagnostic Centre #1
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Saint PetersburgRussiaUnknown status
Regional clinical cardiology dispensary
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SaratovRussiaUnknown status
SHI Saratov City Clinical Hospital #9
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SaratovRussiaUnknown status
Sverdlovsk Regional Clinical Hospital #1
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YekaterinburgRussiaUnknown status
University Hospital Bratislava
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BratislavaSlovakiaActive, not recruiting
DIA Zilina s.r.o.
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ZilinaSlovakiaActive, not recruiting
Medivasa s.r.o.
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ŽilinaSlovakiaActive, not recruiting
University of New Mexico
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AlbuquerqueUnited StatesUnknown status
Lovelace Scientific Resources, Inc.
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AlbuquerqueUnited StatesUnknown status
Michigan Medicine
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Ann ArborUnited StatesUnknown status
Mountain Diabetes & Endocrine Center
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AshevilleUnited StatesUnknown status
Atlanta Diabetes Associates
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AtlantaUnited StatesUnknown status
Barbara Davis Center
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AuroraUnited StatesUnknown status
Rocky Mount Reg VA Med-DN
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AuroraUnited StatesUnknown status
Central Texas Clinical Research
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AustinUnited StatesUnknown status
Texas Diab & Endo, P.A.
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AustinUnited StatesUnknown status
American Health Network of Indiana, LLC_Avon
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AvonUnited StatesUnknown status
Brigham & Women's Hospital
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BostonUnited StatesUnknown status
Joslin Center For Diabetes
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BostonUnited StatesUnknown status
Boston Medical Center_Cary
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BostonUnited StatesUnknown status
Joslin Diabetes Center
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BostonUnited StatesUnknown status
Holston Medical Group Pc
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BristolUnited StatesUnknown status
University of North Carolina
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Chapel HillUnited StatesUnknown status
Onsite Clinical Solutions, LLC
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CharlotteUnited StatesUnknown status
Univ Diab & Endo Consultants
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ChattanoogaUnited StatesUnknown status
Diabetes & Endo Specialists Inc
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ChesterfieldUnited StatesUnknown status
The University Of Chicago
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ChicagoUnited StatesUnknown status
Apex Medical Research Inc
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ChicagoUnited StatesUnknown status
Innovative Research of W FL
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ClearwaterUnited StatesUnknown status
Southern California Res Ctr
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CoronadoUnited StatesUnknown status
FDRC
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Costa MesaUnited StatesUnknown status
UT Southwestern Med Cntr
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DallasUnited StatesUnknown status
Velocity Clinical Res-Dallas
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DallasUnited StatesUnknown status
American Health Network of Indiana, LLC_Greenfield
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GreenfieldUnited StatesUnknown status
Advanced Investigative Medicine, Inc.
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HawthorneUnited StatesUnknown status
Diabetes/Lipid Mgmt & Res Ctr
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Huntington BeachUnited StatesUnknown status
MedStar Hlth Res Institute
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HyattsvilleUnited StatesUnknown status
Est Cst Inst for Rsrch,Jksnvil
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JacksonvilleUnited StatesUnknown status
Holston Medical Group.
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KingsportUnited StatesUnknown status
Scripps Whittier Diabetes Inst
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La JollaUnited StatesUnknown status
Palm Research Center Inc-Vegas
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Las VegasUnited StatesUnknown status
The Research Group of Lexington LLC
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LexingtonUnited StatesUnknown status
VA Medical Center
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LexingtonUnited StatesUnknown status
Kentucky Diabetes-Endocrinology Center
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LexingtonUnited StatesUnknown status
Torrance Clin Res Inst, Inc.
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LomitaUnited StatesUnknown status
Downtown LA Res Ctr. Inc.
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Los AngelesUnited StatesUnknown status
Angel City Research, Inc.
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Los AngelesUnited StatesUnknown status
L-MARC Research Center
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LouisvilleUnited StatesUnknown status
Your Diabetes Endocrine Nutrition Group, Inc.
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MentorUnited StatesUnknown status
Reyes Clinical Research, Inc
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MiamiUnited StatesUnknown status
Riverside University Health System - Medical Center
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Moreno ValleyUnited StatesUnknown status
Synexus Clinical Research US, INC.
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MurrayUnited StatesUnknown status
Southern New Hampshire Diabete
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NashuaUnited StatesUnknown status
Vanderbilt Diab Obes Clin Tri
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NashvilleUnited StatesUnknown status
NYC Research Inc.
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New YorkUnited StatesUnknown status
Renstar Medical Research
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OcalaUnited StatesUnknown status
Harold Hamm Diabetes Center
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Oklahoma CityUnited StatesUnknown status
Four Rivers Clinical Research Inc
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PaducahUnited StatesUnknown status
Aria Endocrine Metabolic Assoc
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PhiladelphiaUnited StatesUnknown status
Tristar Clin Investigations, PC
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PhiladelphiaUnited StatesUnknown status
Synexus Rsch /Cnt Phnx Med C
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PhoenixUnited StatesUnknown status
Rancho Cucamonga Clinical Research
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Rancho CucamongaUnited StatesUnknown status
Synexus Clinical Research US, Inc._Tempe_0
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RichfieldUnited StatesUnknown status
Endo Res Solutions Inc
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RoswellUnited StatesUnknown status
Clinical Trials Research_Sacramento_0
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SacramentoUnited StatesUnknown status
Clinical Trials of Texas LLC
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San AntonioUnited StatesUnknown status
VIP Trials
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San AntonioUnited StatesUnknown status
UCLA Diabetes Center at Santa Monica
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Santa MonicaUnited StatesUnknown status
Consano Clinical Research, LLC
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Shavano ParkUnited StatesUnknown status
MultiCare Inst for Res & Innov
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SpokaneUnited StatesUnknown status
Simcare Medical Research, LLC
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Sugar LandUnited StatesUnknown status
University of Toledo Medical Center
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ToledoUnited StatesUnknown status
South Arizona VA Healthcare System
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TucsonUnited StatesUnknown status
Synexus Cln Rsrch Inc - Orange Gro FP
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TucsonUnited StatesUnknown status
Del Sol Research Management, LLC
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TucsonUnited StatesUnknown status
Coastal Metabolic Research Center
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VenturaUnited StatesUnknown status
Diablo Clinical Research, Inc.
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Walnut CreekUnited StatesUnknown status
Chase Medical Research, LLC
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WaterburyUnited StatesUnknown status
Iowa Diab & Endo Res Center
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West Des MoinesUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.