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NCT05514535CompletedPhase 3

A Research Study to Look Into How Semaglutide, Together With a Lower Dose of Insulin Glargine, Compares to a Higher Dose of Insulin Glargine Alone in People With Type 2 Diabetes (SUSTAIN OPTIMIZE)

Efficacy and Safety of Once-weekly Semaglutide S.C. 2.0 mg as Add-on to Dose-reduced Insulin Glargine vs Titrated Insulin Glargine in Participants With Type 2 Diabetes and Overweight

Source: ClinicalTrials.gov · Last updated 11 May 2026

Brief summary (registry, in English)

This study compares semaglutide, together with a lower dose of insulin glargine, to a higher dose of insulin glargine in participants with type 2 diabetes. The study looks at how well the study medicines control blood glucose levels. Participants will either get semaglutide together with a lower dose of insulin glargine or a higher dose of insulin glargine. The study will last for about 47 weeks (approximately 11 months). Participants will have 9 clinic visits, 15 phone/video calls and 1 home visit. Participants will be asked to wear a sensor that measures their blood sugar all the time in 2 periods of 10 days during the study.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
573 (actual)
First submitted
22 Aug 2022
Start date
29 Aug 2022
Primary completion date
5 Mar 2025
Lead sponsor
Novo Nordisk A/S
NCT number
NCT05514535
EudraCT number
2021-004392-13

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 573
  • From 29 Aug 2022 to the primary completion date, 5 Mar 2025
  • 234 sites in 12 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

  • Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
  • Any episodes of diabetic ketoacidosis within 90 days before screening.

Other illness

  • Presence or history of pancreatitis (acute or chronic).

Lab values

  • Potentially missed diagnosis of Type 1 diabetes (T1D) or latent autoimmune diabetes in adults (LADA) verified by C-peptide less than 0.26 nanomoles per litre (nmol/L) (or 260 picomoles per liter \[pmol/L\] \[0.78 nanograms per millilitre {ng/mL}\]) or antibodies to glutamic acid decarboxylase (anti-GAD) greater than 5 units/millilitre, as measured by the central laboratory at screening.
  • Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of less than 30 millilitre per minute per 1.73 meter square at screening as defined by Kidney Disease: Improving Global Outcomes (KDIGO) 2012 classification.

Other

  • Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire question 8.

Who the study is looking for

  • Diagnosed with Type 2 Diabetes Mellitus (T2D) mellitus greater than or equal to (\>=) 180 days before screening.
  • Glycated haemoglobin (HbA1c) of 7-10 percentage \[(53-86 millimoles per mole (mmol/mol)\] (both inclusive) as assessed by central laboratory on the day of screening.
  • Body mass index (BMI) greater than or equal to (\>=) 25 kilograms per meter square (kg/m\^2) on the day of screening.
  • Stable daily dose(s) greater than or equal to (\>=) 90 days before screening of any of the following anti-diabetic drugs or combination regimens:
  • Any metformin formulations greater than or equal to (\>=) 1500 milligrams (mg) or maximum tolerated or effective dose.
  • Any metformin combination formulation greater than or equal to (\>=) 1500 mg or maximum tolerated or effective dose.
    • The treatment can be with or without sodium glucose cotransporter 2 (SGLT-2) inhibitors.
  • Treated with a once daily basal insulin (e.g. insulin glargine Unit 100 or U300, neutral protamine hagedorn (NPH) insulin, insulin detemir, insulin degludec) less than or equal to (\<=) 40 units/day (U/day) for greater than or equal to (\>=) 90 days before screening. Short-term bolus insulin treatment for a maximum of 14 days before screening is allowed.

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

Full criteria on ClinicalTrials.gov

Sites (234)

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

SiteCityCountrySite status
Edumed s.r.o.
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NáchodCzechiaUnknown status
Diahelp - diabetologie
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PardubiceCzechiaUnknown status
MUDr. Jitka Zemanova - diabetologie a interna, s.r.o.
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Plzen - Vychodni PredmestiCzechiaUnknown status
MUDr. Michala Pelikanova
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PragueCzechiaUnknown status
ResTrial s.r.o.
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PragueCzechiaUnknown status
Diabet2 s.r.o.
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PragueCzechiaUnknown status
Centro Periférico de Especialidades Bola Azul
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AlmeríaSpainUnknown status
ABS La Roca del Vallés
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La Roca Del VallésSpainUnknown status
ABS La Roca del Vallés_Endocrinología
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La Roca Del VallésSpainUnknown status
Hospital Infanta Leonor
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MadridSpainUnknown status
Hospital Son Espases
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Palma de MallorcaSpainUnknown status
H. Infanta Luisa_Endocrino y Obesidad
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SevilleSpainUnknown status
University Hospital of Alexandroupolis
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AlexandroupoliGreeceUnknown status
Laiko General Hospital of Athens
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AthensGreeceUnknown status
University Hospital of Athens ATTIKON
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AthensGreeceUnknown status
Alexandra General Hospital, Therapeutic Clinic
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AthensGreeceUnknown status
Geniko Nosokomeio Nikaias Peiraia Ag. Panteleimon Geniko Nosokomeio Dytikis Attikis I - Diabetes Department
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NikaiaGreeceUnknown status
Geniko Nosokomeio Peiraia Tzaneio
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PiraeusGreeceUnknown status
AHEPA General University Hospital
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ThessalonikiGreeceUnknown status
EUROMEDICA Gen Clinic The/ki, Endocrin,Metabolism,Diabetes
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ThessalonikiGreeceUnknown status
General Hospital of Thessaloniki "G. Papanikolaou"
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ThessalonikiGreeceUnknown status
"Thermi" Private Hosital
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ThessalonikiGreeceUnknown status
Azienda Ospedaliera Papa Giovanni XXIII
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BergamoItalyUnknown status
Policlinico Mater Domini Università di Catanzaro
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CatanzaroItalyUnknown status
Ospedale Santa Maria Goretti - UOD Diabetologia
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LatinaItalyUnknown status
Azienda Unita' Sanitaria Locale Toscana Nord Ovest - Cittadella della Salute Campo di Marte
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LuccaItalyUnknown status
Istituto Scientifico San Raffaele
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MilanItalyUnknown status
ASST degli Spedali Civili di Brescia-Presidio Ospedaliero di Montichiari
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MontichiariItalyUnknown status
A.O.U. Università Studi della Campania "Luigi Vanvitelli"
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NaplesItalyUnknown status
Azienda Ospedaliera di Perugia;Ospedale S. Maria della Misericordia
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PerugiaItalyUnknown status
Policlinico Umberto I Seconda Clinica Medica
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RomaItalyUnknown status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Dipartimento di scienze Mediche e Chirurgiche
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RomeItalyUnknown status
Caribbean Medical Research Center
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San JuanPuerto RicoUnknown status
ULS de Almada -Seixal, E. P. E. - Hospital Garcia de Orta
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AlmadaPortugalUnknown status
ULS Da Regiao De Aveiro E.P.E. - Hospital Infante D. Pedro
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AveiroPortugalUnknown status
ULS De Braga, E.P.E. - Hospital de Braga
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BragaPortugalUnknown status
ULS Do Oeste E.P.E. - Unidade Caldas da Rainha
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Caldas da RainhaPortugalUnknown status
ULS Da Região De Leiria E.P.E.- Hospital de Santo André
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LeiriaPortugalUnknown status
Unidade Local De Saúde De São José, E.P.E. - Hospital Curry Cabral
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LisbonPortugalUnknown status
Unidade Local De Saúde De Lisboa Ocidental E.P.E. - Hospital Egas Moniz
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LisbonPortugalUnknown status
ULS De Santo António, E.P.E. - Hospital de Santo António
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PortoPortugalUnknown status
ULS De São João, E.P.E. - Hospital de São João
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PortoPortugalUnknown status
ULS De Matosinhos E.P.E.- Hospital Pedro Hispano
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Senhora Da Hora, MatosinhosPortugalUnknown status
ULS Do Alto Minho E.P.E. - Hospital de Santa Luzia
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Viana do CasteloPortugalUnknown status
CMI Dr Pop Lavinia
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Baia MareRomaniaUnknown status
Clinica Grivitei 224 S.R.L.
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BrăilaRomaniaUnknown status
Mariodiab Clinic SRL
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BrasovRomaniaUnknown status
Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed
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BrasovRomaniaUnknown status
Diabs&Nutricare Srl
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BucharestRomaniaUnknown status
Clinic of Diabetes Constanta
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ConstanțaRomaniaUnknown status
Clinical Emergency Sf. Apostol Andrei Hospital
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GalatiRomaniaUnknown status
SC Consultmed SRL
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IașiRomaniaUnknown status
Medical Practice SRL
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OradeaRomaniaUnknown status
Grandmed SRL
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OradeaRomaniaUnknown status
S.C. Dianutrilife Medica S.R.L.
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PloieştiRomaniaUnknown status
Novus Medical Clinica SRL
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PloieştiRomaniaUnknown status
Clinica Korall S.R.L. Satu Mare
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Satu MareRomaniaUnknown status
Spitalul Judetean de Urgenta Targoviste
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TargovisteRomaniaUnknown status
Dentosim Queen Srl
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Târgu MureşRomaniaUnknown status
Centrul Medical Sfantul Stefan
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TimișoaraRomaniaUnknown status
Volosevich First City Clinical Hospital
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ArkhangelskRussiaUnknown status
SPb SBHI "Snegirev Maternity Hospital No. 6"
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Saint PetersburgRussiaUnknown status
Medinet LLC
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Saint PetersburgRussiaUnknown status
Medical Research Institute LLC
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Saint PetersburgRussiaUnknown status
SPb SBHI City polyclinic #117
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Saint PetersburgRussiaUnknown status
Solovyov Clinical Emergency Hospital
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YaroslavlRussiaUnknown status
Solovyev Clinical Emergency Hospital
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YaroslavlRussiaUnknown status
DIA - CLARUS s.r.o.
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BojniceSlovakiaUnknown status
MediTask, s.r.o
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BratislavaSlovakiaUnknown status
Medispektrum s.r.o
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BratislavaSlovakiaUnknown status
DIA-MAX s.r.o.
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LeviceSlovakiaUnknown status
IN-DIA s.r.o.
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LučenecSlovakiaUnknown status
DIA - SANTMART, s.r.o., Ambulancia diabetologie a poruch latkovej premeny a vyzivy
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MartinSlovakiaUnknown status
FUNKYSTUFF s.r.o.
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Nové ZámkySlovakiaUnknown status
Diakom, spol. s r.o.
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PopradSlovakiaUnknown status
DIALIPID, s.r.o.
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PrešovSlovakiaUnknown status
Tatratrial s.r.o.
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RožňavaSlovakiaUnknown status
Amb. Diabetologie a prouch latkovej premeny a vyzivy ENDIANT s.r.o.
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SereďSlovakiaUnknown status
BENROD s.r.o.
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ŠtúrovoSlovakiaUnknown status
MUDr. Korecova, metabolicke centrum s.r.o.
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TrenčínSlovakiaUnknown status
Kharkiv Regional Clinical Hospital - Endocrinology department
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KharkivUkraineUnknown status
Khmelnytskyi Regional Hospital - Endocrinology department
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KhmelnytskyiUkraineUnknown status
Ternopil Central District Hospital - Outpatient department
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TernopilUkraineUnknown status
Medical centre"Elitmedservis"LLC
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ZaporizhzhyaUkraineUnknown status
AMC Community Endocrinology
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AlbanyUnited StatesUnknown status
Amarillo Med Spec LLP
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AmarilloUnited StatesUnknown status
Arlington Family Res. Ctr Inc
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ArlingtonUnited StatesUnknown status
CVS Store Number: 7689
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AtlantaUnited StatesUnknown status
Central Texas Clinical Research
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AustinUnited StatesUnknown status
Velocity Clin Res Cleveland
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BeachwoodUnited StatesUnknown status
Heritage Valley Multispeciality Group Inc
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BeaverUnited StatesUnknown status
Joslin Diabetes Center
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BostonUnited StatesUnknown status
Brigham & Women's Hospital
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BostonUnited StatesUnknown status
Dr. Alexander Perkelvald
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BrooklynUnited StatesUnknown status
Northern Pines Hlth Ctr, PC
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BuckleyUnited StatesUnknown status
Mercury Str Med Grp, PLLC
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ButteUnited StatesUnknown status
San Fernando Valley Hlth Inst, LLC
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Canoga ParkUnited StatesUnknown status
Diab & Endo Assoc of Stark Co
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CantonUnited StatesUnknown status
East Coast Institute for Res
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CantonUnited StatesUnknown status
Velocity Clin Res Austin
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Cedar ParkUnited StatesUnknown status
University of North Carolina Medical Center
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Chapel HillUnited StatesUnknown status
Chattanooga Medical Research, LLC
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ChattanoogaUnited StatesUnknown status
Univ Diab & Endo Consultants
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ChattanoogaUnited StatesUnknown status
Virginia Endo Res, LLC
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ChesapeakeUnited StatesUnknown status
Cedar Crosse Research Center
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ChicagoUnited StatesUnknown status
WellNow Urgent Care
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ChicagoUnited StatesUnknown status
Velocity Clin Res-Chula Vista
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Chula VistaUnited StatesUnknown status
Velocity Clin Res_Cincinnati
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CincinnatiUnited StatesUnknown status
StudyMetrix Research, LLC
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City of Saint PetersUnited StatesUnknown status
John Muir Physicians Network
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ConcordUnited StatesUnknown status
West Broadway Clinic
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Council BluffsUnited StatesUnknown status
Velocity Clinical Res-Dallas
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DallasUnited StatesUnknown status
Thyroid Endocrinology & Diabetes PA
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DallasUnited StatesUnknown status
Velocity Clin Res, Denver
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DenverUnited StatesUnknown status
Henry Ford Health System
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DetroitUnited StatesUnknown status
Clinical Research Advantage, Inc./Skyline Medical Center, PC
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ElkhornUnited StatesUnknown status
Academy of Diabetes, T&E
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El PasoUnited StatesUnknown status
Lillestol Research, LLC
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FargoUnited StatesUnknown status
Elite Research Center
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FlintUnited StatesUnknown status
Diabetes and Thyroid Ctr of FW
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Fort WorthUnited StatesUnknown status
Methodist Physicians Clinic
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FremontUnited StatesUnknown status
Valley Research
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FresnoUnited StatesUnknown status
Providence Medical Foundation
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FullertonUnited StatesUnknown status
Ascada Research
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FullertonUnited StatesUnknown status
Lenzmeier Fam Med CCT Research
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GlendaleUnited StatesUnknown status
Prevea Health
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Green BayUnited StatesUnknown status
Physicians East Endocrinology
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GreenvilleUnited StatesUnknown status
Indago Research & Health Center, Inc
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HialeahUnited StatesUnknown status
Coastal Heritage Clinical Research
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HinesvilleUnited StatesUnknown status
Encore Medical Research LLC
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HollywoodUnited StatesUnknown status
Gonzalez Family & Occupational Medicine
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HoustonUnited StatesUnknown status
Houston Institute for Clinical Research
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HoustonUnited StatesUnknown status
JCCT- Juno NW Houston
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HoustonUnited StatesUnknown status
Velocity Clinical Research-Huntington Park
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Huntington ParkUnited StatesUnknown status
Protenium Clinical Research
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HurstUnited StatesUnknown status
MedStar Hlth Res Institute
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HyattsvilleUnited StatesUnknown status
Brengle Family Medicine
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IndianapolisUnited StatesUnknown status
Jackson Clinic
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JacksonUnited StatesUnknown status
Care-Partners-Clinical-Research, LLC
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JacksonvilleUnited StatesUnknown status
Jacksonville Ctr for Clin Res
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JacksonvilleUnited StatesUnknown status
Northeast Res Inst. Inc.
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JacksonvilleUnited StatesUnknown status
Richard M Kastelic MD Assoc
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JohnstownUnited StatesUnknown status
Holston Medical Group.
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KingsportUnited StatesUnknown status
Accellacare US Inc., d/b/a Accellacare of Knoxville
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KnoxvilleUnited StatesUnknown status
Scripps Memorial Hospital La Jolla
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La JollaUnited StatesUnknown status
Velocity Clin Res San Diego
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La MesaUnited StatesUnknown status
First Valley Medical Group
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LancasterUnited 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
Loma Linda Univ Hlth Cr Endo
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Loma LindaUnited StatesUnknown status
Torrance Clin Res Inst, Inc.
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LomitaUnited StatesUnknown status
DCOL Ctr for Clin Res
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LongviewUnited StatesUnknown status
NRC Research Institute
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Los AngelesUnited StatesUnknown status
Velocity Clin Res Los Angeles
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Los AngelesUnited StatesUnknown status
Downtown LA Res Ctr. Inc.
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Los AngelesUnited StatesUnknown status
L-MARC Research Center
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LouisvilleUnited StatesUnknown status
East Coast Institute for Res
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MaconUnited StatesUnknown status
Albert J Weisbrot
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MasonUnited StatesUnknown status
Advanced Med Res Maumee
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MaumeeUnited StatesUnknown status
Tekton Research
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McKinneyUnited StatesUnknown status
Velocity Clinical Res Medford
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MedfordUnited StatesUnknown status
Clinical Neuroscience Solutions
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MemphisUnited StatesUnknown status
Solaris Clinical Research
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MeridianUnited StatesUnknown status
Synexus Clinical Research US, Inc./Desert Clinical Research,
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MesaUnited StatesUnknown status
New Horizon Research Center
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MiamiUnited StatesUnknown status
International Research Associates, LLC_Miami
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MiamiUnited StatesUnknown status
Elite Research Center
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MiamiUnited StatesUnknown status
Suncoast Research Group, LLC
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MiamiUnited StatesUnknown status
Reyes Clinical Research, Inc
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MiamiUnited StatesUnknown status
Diverse Clinical Research Miami
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MiamiUnited StatesUnknown status
South Broward Research LLC
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MiramarUnited StatesUnknown status
Arthritis And Diabetes Clinic, Inc.
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MonroeUnited StatesUnknown status
Carteret Medical Group
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Morehead CityUnited StatesUnknown status
Centricity Rsrch MHCity Multi
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Morehead CityUnited StatesUnknown status
WVU Medicine
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MorgantownUnited StatesUnknown status
Carolina Health Specialists
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Myrtle BeachUnited StatesUnknown status
Southern New Hampshire Diabetes and Endocrinology
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NashuaUnited StatesUnknown status
AMR New Orleans
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New OrleansUnited StatesUnknown status
Suncoast Clin Res Port Richey
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New Port RicheyUnited StatesUnknown status
Suncoast Clinical Research, Inc._New Port Richey
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New Port RicheyUnited StatesUnknown status
Mid Hudson Med Res-New Windsor
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New WindsorUnited StatesUnknown status
York Clinical Research LLC
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NorfolkUnited StatesUnknown status
Velocity Clin Res, Norfolk
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NorfolkUnited StatesUnknown status
Lynn Institute of Norman
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NormanUnited StatesUnknown status
Intend Research
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NormanUnited StatesUnknown status
Valley Clinical Trials, Inc.
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NorthridgeUnited StatesUnknown status
Renstar Medical Research
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OcalaUnited StatesUnknown status
South Ogden Family Medicine/ CCT Research
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OgdenUnited StatesUnknown status
Advanced Research Institute
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OgdenUnited StatesUnknown status
Midwest Regional Health Services
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OmahaUnited StatesUnknown status
Univ of Nebraska Medical CTR
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OmahaUnited StatesUnknown status
Thomas Jefferson University
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PhiladelphiaUnited StatesUnknown status
Clinical Investigations of Texas
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PlanoUnited StatesUnknown status
CVS Store Number: 01396
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RestonUnited StatesUnknown status
CVS Store Number: 1537
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RichmondUnited StatesUnknown status
Endo And Metab Cons
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RockvilleUnited StatesUnknown status
Endocrine Research Solutions
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RoswellUnited StatesUnknown status
Olympus Family Medicine
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Salt Lake CityUnited StatesUnknown status
VIP Trials
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San AntonioUnited StatesUnknown status
Diabetes Glandular Diseases Clinic
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San AntonioUnited StatesUnknown status
San Antonio Prem Int Med
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San AntonioUnited StatesUnknown status
Briggs Clinical Research, LLC
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San AntonioUnited StatesUnknown status
Wetlin Research Associates, Inc.
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San DiegoUnited StatesUnknown status
San Diego Family Care_San Diego
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San DiegoUnited StatesUnknown status
CVS Store Number: 05520
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SavannahUnited StatesUnknown status
Unity Health-Searcy Medical Center
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SearcyUnited StatesUnknown status
OneLife Direct Care Inc.
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SearcyUnited StatesUnknown status
Consano Clinical Research, LLC
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Shavano ParkUnited StatesUnknown status
Shoals Primary Care
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SheffieldUnited StatesUnknown status
Ileana J. Tandron, MD APMC (a private medical office)
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SlidellUnited StatesUnknown status
Chrysalis Clinical Research
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St. GeorgeUnited StatesUnknown status
Med-Olam Clinical Reseach LLC
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Sugar LandUnited StatesUnknown status
Palmetto Clinical Research
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SummervilleUnited StatesUnknown status
Clinical Research Trials of Florida
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TampaUnited StatesUnknown status
University of Toledo_Toledo
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ToledoUnited StatesUnknown status
University of Toledo Medical Center
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ToledoUnited StatesUnknown status
Cotton O'Neil Diab & Endo Ctr
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TopekaUnited StatesUnknown status
Premier Research Inc.
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TrentonUnited StatesUnknown status
Arcturus HC PLC Troy Med Res
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TroyUnited StatesUnknown status
University Clin Investigators
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TustinUnited StatesUnknown status
Preferred Primary Care Physicians, Inc.
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UniontownUnited StatesUnknown status
Hillcrest Family Health Center
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WacoUnited 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
Great Lakes Medical Research
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WestfieldUnited StatesUnknown status
Velocity Clin Res-Salt Lk City
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West JordanUnited StatesUnknown status
Amherst Family Practice P.C.
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WinchesterUnited StatesUnknown status
Diabetes Care Centre & CDE Centre
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BenoniSouth AfricaUnknown status
East Rand Physicians
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BenoniSouth AfricaUnknown status
Dr J Reddy
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DurbanSouth AfricaUnknown status
Dr Pillay's Rooms
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DurbanSouth AfricaUnknown status
Dr T Padayachee
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eMkhomaziSouth AfricaUnknown status
Centre for Diabetes
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JohannesburgSouth AfricaUnknown status
East Rand Physicians
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JohannesburgSouth AfricaUnknown status

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