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NCT05275400CompletedPhase 3

A Study of Insulin Efsitora Alfa (LY3209590) Compared With Insulin Degludec in Participants With Type 2 Diabetes Currently Treated With Basal Insulin

A Phase 3, Multicenter, Randomized, Parallel-Design, Open-Label Trial to Evaluate the Efficacy and Safety of LY3209590 Compared With Insulin Degludec in Participants With Type 2 Diabetes Currently Treated With Basal Insulin (QWINT-3)

Source: ClinicalTrials.gov · Last updated 3 Jun 2025

Brief summary (registry, in English)

The reason for this study is to see if the study drug insulin efsitora alfa (LY3209590) is safe and effective in participants with Type 2 diabetes that have already been treated with basal insulin. The study consists of a 3-week screening/lead-in period, a 78-week treatment period and a 5-week safety follow-up period. The study will last up to 86 weeks.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
986 (actual)
First submitted
3 Mar 2022
Start date
8 Mar 2022
Primary completion date
15 May 2024
Lead sponsor
Eli Lilly and Company
NCT number
NCT05275400
EudraCT number
2021-002569-16

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 986
  • From 8 Mar 2022 to the primary completion date, 15 May 2024
  • 127 sites in 10 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

  • Have received anytime in the past 6 months, any of the following insulin therapies:
    • prandial insulin
    • insulin mixtures
    • inhaled insulin
    • U-500 insulin, or
    • continuous subcutaneous insulin infusion therapy
  • Gastrointestinal: have undergone gastric bypass (bariatric) surgery, restrictive bariatric surgery (Lap-Band) or sleeve gastrectomy within 1 year prior to screening

Other illness

  • Have Type 1 diabetes mellitus
  • Have acute or chronic hepatitis, cirrhosis, or obvious clinical signs or symptoms of any other liver disease, except Nonalcoholic Fatty Liver Disease (NAFLD)
  • Have active or untreated malignancy
  • Have had any of New York Heart Association Class IV heart failure or any of the following CV conditions in the past 3 months:
    • acute myocardial infarctions
    • cerebrovascular accident (stroke), or
    • coronary bypass surgery

Lab values

  • Estimated glomerular filtration rate (eGFR) \<20 milliliters/minute/1.73 square meter (m²)

Other

  • Are pregnant
  • Have a significant weight gain or loss the past 3 months

Who the study is looking for

  • Have been diagnosed with Type 2 diabetes according to the World Health Organization (WHO) criteria treated with basal insulin
  • Are receiving ≥10 units of basal insulin per day and ≤110 units per day at screening
  • Have HbA1c value of 6.5% - 10% inclusive, at screening
  • Have a Body mass index (BMI) less than or equal to 45 kilogram/square meter (kg/m²)
  • Have been treated with one of the following stable insulin regimens at least 90 days prior to screening:
    • once daily U100 or U200 of insulin degludec
    • once daily U100 or U300 of insulin glargine
    • once or twice daily U100 of insulin detemir, or
    • once or twice daily human insulin NPH
  • acceptable non insulin glucose lowering therapies may include 0 to up to 3 of the following:
    • dipeptidyl peptidase (DPP-4) IV inhibitors
    • SGLT2 inhibitors
    • metformin
    • alphaglucosidase inhibitors or,
    • Glucagon-Like Peptide-1 (GLP-1) receptor agonists
    • Participants must be willing to stay on stable dose throughout the study

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

Full criteria on ClinicalTrials.gov

Sites (127)

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

SiteCityCountrySite status
CEMEDIC
Coordinator of this site? Confirm its status
Buenos AiresArgentinaUnknown status
Mautalen Salud e Investigación
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Buenos AiresArgentinaUnknown status
Centro Médico Viamonte
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Buenos AiresArgentinaUnknown status
Instituto Centenario
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CABAArgentinaUnknown status
Centro Medico Privado CEMAIC
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CapitalArgentinaUnknown status
Consultorio de Investigación Clínica EMO SRL
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Ciudad Autonoma de Buenos AireArgentinaUnknown status
Centro de Investigaciones Metabólicas (CINME)
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Ciudad Autónoma de Buenos AireArgentinaUnknown status
CENUDIAB
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Ciudad Autónoma de Buenos AireArgentinaUnknown status
Stat Research S.A.
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Ciudad Autónoma de Buenos AireArgentinaUnknown status
Centro Diabetológico Dr. Waitman
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CórdobaArgentinaUnknown status
CIPADI - Centro Integral de Prevencion y Atencion en Diabetes
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Godoy CruzArgentinaUnknown status
Instituto de Investigaciones Clinicas Mar del Plata
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Mar del PlataArgentinaUnknown status
Instituto Médico Catamarca IMEC
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RosarioArgentinaUnknown status
Go Centro Medico San Nicolas
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San Nicolás de los ArroyosArgentinaUnknown status
CHUAC-Complejo Hospitalario Universitario A Coruña
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A CoruñaSpainUnknown status
Centro Periférico de Especialidades Bola Azul
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AlmeríaSpainUnknown status
Hospital Universitario de La Ribera
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AlziraSpainUnknown status
Hospital Universitari Vall d'Hebron
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BarcelonaSpainUnknown status
Hospital Universitario Virgen de la Victoria
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MálagaSpainUnknown status
Clínica Juaneda
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Palma de MallorcaSpainUnknown status
Hospital Universitario Marqués de Valdecilla
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SantanderSpainUnknown status
Hospital Quiron Infanta Luisa
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SevilleSpainUnknown status
Vithas Hospital Sevilla
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SevilleSpainUnknown status
Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)
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SevilleSpainUnknown status
Hospital General Universitario de Valencia
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ValenciaSpainUnknown status
DRC Gyógyszervizsgáló Központ
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BalatonfüredHungaryUnknown status
Szent János Kórház
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BudapestHungaryUnknown status
Szent Margit Rendelointézet
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BudapestHungaryUnknown status
Strazsahegy Medicina Bt.
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BudapestHungaryUnknown status
Kanizsai Dorottya Korhaz
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NagykanizsaHungaryUnknown status
Zala Megyei Szent Rafael Korhaz
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ZalaegerszegHungaryUnknown status
Fukuwa Clinic
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Chuo-kuJapanUnknown status
The Institute of Medical Science, Asahi Life Foundation
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Chuo-kuJapanUnknown status
Tokyo-Eki Center-building Clinic
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Chuo-kuJapanUnknown status
Medical Corporation Chiseikai Tokyo Center Clinic
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Chuo-kuJapanUnknown status
Matoba Internal Medicine Clinic
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EbinaJapanUnknown status
Takai Internal Medicine Clinic
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Kamakura-shiJapanUnknown status
Shiraiwa Medical Clinic
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KashiharaJapanUnknown status
Jinnouchi Hospital
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KumamotoJapanUnknown status
Tokuyama Clinic
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Mihama-ku,Chiba CityJapanUnknown status
Nakamoto Internal Medicine Clinic
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MitoJapanUnknown status
Kozawa Eye Hospital and Diabetes Center
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MitoJapanUnknown status
Heiwadai Hospital
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MiyazakiJapanUnknown status
Abe Clinic
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ŌitaJapanUnknown status
AMC Nishiumeda Clinic
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OsakaJapanUnknown status
Oyama East Clinic
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OyamaJapanUnknown status
Shimizu Clinic Fusa
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Saitama-shiJapanUnknown status
Yuri Ono Clinic
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SapporoJapanUnknown status
Takatsuki Red Cross Hospital
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TakatsukiJapanUnknown status
Noritake Clinic
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UshikuJapanUnknown status
Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic
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Yamato-shiJapanUnknown status
Korea University Ansan Hospital
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Ansan-siSouth KoreaUnknown status
Kangwon National University Hospital
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ChuncheonSouth KoreaUnknown status
Hanyang University Guri Hospital
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Guri-siSouth KoreaUnknown status
Yeungnam Univeristy Medical Center
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Gyeongsan-siSouth KoreaUnknown status
Asan Medical Center
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SeoulSouth KoreaUnknown status
Kyung Hee University Hospital at Gangdong
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SeoulSouth KoreaUnknown status
Inje University Sanggye Paik Hospital
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SeoulSouth KoreaUnknown status
Seoul National University Hospital
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SeoulSouth KoreaUnknown status
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaUnknown status
Hallym University Kangnam Sacred Heart Hospital
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SeoulSouth KoreaUnknown status
Ulsan University Hospital
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UlsanSouth KoreaUnknown status
Yonsei University Wonju Severance Christian Hospital
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WŏnjuSouth KoreaUnknown status
Centrum Badan Klinicznych PI-House sp. z o.o.
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GdanskPolandUnknown status
NZOZ Diab-Endo-Met
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KrakowPolandUnknown status
Centrum Terapii Wspolczesnej J.M.Jasnorzewska Spolka Komandytowo-Akcyjna
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LódzPolandUnknown status
NZOZ Medica
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LublinPolandUnknown status
CenterMed Lublin NZOZ
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LublinPolandUnknown status
Gabinety TERPA
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LublinPolandUnknown status
IRMED
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Piotrkow TrybunalskiPolandUnknown status
Gaja Poradnie Lekarskie Maciej Wiza
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PoznanPolandUnknown status
OMEDICA Medical Center
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PoznanPolandUnknown status
NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki
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Ruda ŚląskaPolandUnknown status
Private Practice - Dr. Robert Witek
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TarnówPolandUnknown status
GCM Medical Group, PSC - Hato Rey Site
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San JuanPuerto RicoUnknown status
Mgcendo Llc
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San JuanPuerto RicoUnknown status
Diacrin .s.ro.
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BratislavaSlovakiaUnknown status
ENDIAMED s.r.o
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Dolný KubínSlovakiaUnknown status
HUMAN-CARE, s.r.o.
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KošiceSlovakiaUnknown status
MediVet s.r.o.
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MalackySlovakiaUnknown status
DIA-MED CENTRUM s.r.o.
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PúchovSlovakiaUnknown status
MEDI-DIA s.r.o.
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SabinovSlovakiaUnknown status
Areteus s.r.o.
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TrebišovSlovakiaUnknown status
Fu Jen Catholic University Hospital
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New Taipei CityTaiwanUnknown status
Taichung Veterans General Hospital
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TaichungTaiwanUnknown status
Chung Shan Medical University Hospital
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TaichungTaiwanUnknown status
National Cheng Kung University Hospital
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TainanTaiwanUnknown status
Chi Mei Medical Center
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TainanTaiwanUnknown status
Taipei Veterans General Hospital
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TaipeiTaiwanUnknown status
Albany Medical College, Division of Community Endocrinology
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AlbanyUnited StatesUnknown status
Gadolin Research
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BeaumontUnited StatesUnknown status
Heritage Valley Medical Group, Inc.
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BeaverUnited StatesUnknown status
Aventiv Research Inc
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ColumbusUnited StatesUnknown status
John Muir Physician Network Research Center
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ConcordUnited StatesUnknown status
Dallas Diabetes Research Center
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DallasUnited StatesUnknown status
AMCR Institute
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EscondidoUnited StatesUnknown status
Lillestol Research
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FargoUnited StatesUnknown status
SKY Clinical Research Network Group - Hall
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FayetteUnited StatesUnknown status
Encore Medical Research
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HollywoodUnited StatesUnknown status
Biopharma Informatic, LLC
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HoustonUnited StatesUnknown status
Juno Research
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HoustonUnited StatesUnknown status
National Research Institute - Huntington Park
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Huntington ParkUnited StatesUnknown status
Rocky Mountain Clinical Research
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Idaho FallsUnited StatesUnknown status
Scripps Whittier Diabetes Institute
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La JollaUnited StatesUnknown status
Palm Research Center Tenaya
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Las VegasUnited StatesUnknown status
Balanced Life Health Care Solutions/SKYCRNG
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LawrencevilleUnited StatesUnknown status
Medical Investigations
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Little RockUnited StatesUnknown status
L-MARC Research Center
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LouisvilleUnited StatesUnknown status
Southern Endocrinology Associates
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MesquiteUnited StatesUnknown status
New Horizon Research Center
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MiamiUnited StatesUnknown status
HealthPartners Institute dba International Diabetes Center
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MinneapolisUnited StatesUnknown status
Suncoast Clinical Research, Inc.
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New Port RicheyUnited StatesUnknown status
NYC Research
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New YorkUnited StatesUnknown status
Intend Research, LLC
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NormanUnited StatesUnknown status
West Orange Endocrinology
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OcoeeUnited StatesUnknown status
Diabetes Associates Medical Group
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OrangeUnited StatesUnknown status
Jefferson Clinical Research Institute (JCRI)
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PhiladelphiaUnited StatesUnknown status
Rainier Clinical Research Center
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RentonUnited StatesUnknown status
Endocrine and Metabolic Consultants
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RockvilleUnited StatesUnknown status
Texas Diabetes & Endocrinology, P.A.
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Round RockUnited StatesUnknown status
Consano Clinical Research, LLC
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Shavano ParkUnited StatesUnknown status
Clinvest Research, LLC
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SpringfieldUnited StatesUnknown status
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
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TroyUnited StatesUnknown status
University Clinical Investigators, Inc.
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TustinUnited StatesUnknown status
Preferred Primary Care Physicians
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UniontownUnited StatesUnknown status
Chase Medical Research, LLC
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WaterburyUnited StatesUnknown status
Iowa Diabetes and Endocrinology Research Center
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West Des MoinesUnited StatesUnknown status

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