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NCT05486065CompletedPhase 2

A Research Study to Look Into How Well Semaglutide Medicine Works at Different Doses in People With Type 2 Diabetes and Overweight

Investigation of Once-weekly Semaglutide S.C. Dose-Response in Patients With Type 2 Diabetes and Overweight - a Participant- and Investigator-blinded and Sponsor Open-label Study

Source: ClinicalTrials.gov · Last updated 12 Dec 2025

Brief summary (registry, in English)

This study compares how three doses of semaglutide work in participants with type 2 diabetes (T2D) and overweight who are taking metformin. The study will look mainly at how well participant's blood sugar and participant's body weight are controlled when they are taking the study medicine at different doses. Participants will either get semaglutide \[2 milligrams (mg), 8 mg, or 16 mg\] or semaglutide placebo (a dummy medicine). Participants will take the study medicine with an injection pen called NovoPen®4. The injection pen is a medical tool with a needle used to inject the study medicine under the skin. The study will last for about 52 weeks. Participants will have 13 clinic visits and 4 phone calls.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
245 (actual)
First submitted
31 Jul 2022
Start date
8 Aug 2022
Primary completion date
12 Oct 2023
Lead sponsor
Novo Nordisk A/S
NCT number
NCT05486065
EudraCT number
2022-000882-41

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 245
  • From 8 Aug 2022 to the primary completion date, 12 Oct 2023
  • 130 sites in 5 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 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes.
  • Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to day of 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.

Lab values

  • Renal impairment measured as estimated glomerular filtration rate (eGFR) value of less than (\<) 30 milliliters per minute (mL/min)/1.73 meter square (m\^2) at screening.

Who the study is looking for

  • Male or female.
  • Aged 18-64 years (both inclusive) at the time of signing informed consent.
  • Diagnosed with type 2 diabetes mellitus greater than equal to (≥) 180 days prior to the day of screening.
  • Glycosylated haemoglobin (HbA1c) of 7.0 - 10.5 percentage (%) \[53 - 91 millimoles per mole (mmol/mol)\] (both inclusive).
  • Body Mass Index (BMI) ≥ 27.0 kilograms per meter square (kg/m\^2).
  • Stable daily dose(s) ≥ 90 days prior to the day of screening of any metformin formulations.

Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (130)

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

SiteCityCountrySite status
Gen Hospital of Athens Laiko,1st Dpt. of Propaedeutic Inter
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AthensGreeceUnknown status
University Hospital of Athens ATTIKON
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AthensGreeceUnknown status
Iatriko Psychicou Private Clinic
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AthensGreeceUnknown status
Alexandra General Hospital, Therapeutic Clinic
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AthensGreeceUnknown status
Iatriko Athinon (Athens Medical Canter)
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AthensGreeceUnknown status
Iatriko Athinon 'Palaiou Falirou'
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AthensGreeceUnknown status
Univ Gen Hospital Larisa
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LarissaGreeceUnknown status
EUROMEDICA Gen Clinic The/ki, Endocrin,Metabolism,Diabetes
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ThessalonikiGreeceUnknown status
General Hospital of Thessaloniki G. Gennimatas
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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
Ippokrateio General Hospital of Thessaloniki
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ThessalonikiGreeceUnknown status
MH Egészségügyi Központ
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BudapestHungaryUnknown status
ClinDiab Egészségügyi Szolgáltató és Kereskedelmi Kft.
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BudapestHungaryUnknown status
Szent Margit Rendelőintézet Nonprofit Kft
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BudapestHungaryUnknown status
Bajcsy-Zsilinszky Kórház
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BudapestHungaryUnknown status
Komaromi Selye Janos Korhaz
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KomáromHungaryUnknown status
Kanizsai Dorottya Korhaz
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NagykanizsaHungaryUnknown status
Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ
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SzegedHungaryUnknown status
Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz
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SzombathelyHungaryUnknown status
NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Małgorzata Arciszewska
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BialystokPolandUnknown status
NZOZ Vita-Diabetica Malgorzata Buraczyk
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BialystokPolandUnknown status
Pro Familia Altera Sp. z o.o.
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KatowicePolandUnknown status
Clinmedica Research sp. z o.o.
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SkierniewicePolandUnknown status
Velocity Nova Sp. z o.o.
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StaszowPolandUnknown status
KO-MED Centra Kliniczne Staszow
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StaszówPolandUnknown status
Nbr Polska Tomasz Klodawski
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WarsawPolandUnknown status
Nbr Polska
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WarsawPolandUnknown status
Manati Ctr For Clin Research
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ManatiPuerto RicoUnknown status
Appalachian Clinical Res LLC
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AdairsvilleUnited StatesUnknown status
Biofortis Clinical Research
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AddisonUnited StatesUnknown status
AMC Community Endocrinology
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AlbanyUnited StatesUnknown status
Amarillo Med Spec LLP
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AmarilloUnited StatesUnknown status
Velocity Clinical Res-Banning
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BanningUnited StatesUnknown status
Univ of Alabama Birmingham
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BirminghamUnited StatesUnknown status
University of Alabama Birmingham
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BirminghamUnited StatesUnknown status
Brigham & Women's Hospital
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BostonUnited StatesUnknown status
UNC Eastowne Clinical Research Unit
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Chapel HillUnited StatesUnknown status
Chattanooga Medical Research, LLC
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ChattanoogaUnited StatesUnknown status
Cedar Crosse Research Center
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ChicagoUnited StatesUnknown status
Velocity Clin Res-Chula Vista
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Chula VistaUnited StatesUnknown status
StudyMetrix Research, LLC
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City of Saint PetersUnited StatesUnknown status
Innovative Research of W FL
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ClearwaterUnited StatesUnknown status
Tampa Bay Medical Research
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ClearwaterUnited StatesUnknown status
Optumcare Clinical Trials,LLC-Golden
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Colorado SpringsUnited StatesUnknown status
Velocity Clinical Research, Columbia
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ColumbiaUnited StatesUnknown status
Alliance for Multispec Res
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Coral GablesUnited StatesUnknown status
Southern California Res Ctr
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CoronadoUnited StatesUnknown status
West Broadway Clinic
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Council BluffsUnited StatesUnknown status
Velocity Clinical Res-Dallas
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DallasUnited StatesUnknown status
UT Southwestern Med Cntr
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DallasUnited StatesUnknown status
Providence Health Partners Ctr
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DaytonUnited StatesUnknown status
University Clin Res-Deland
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DeLandUnited StatesUnknown status
Cedars-Sinai Medical Group
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EncinoUnited StatesUnknown status
Lillestol Research, LLC
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FargoUnited StatesUnknown status
Northeast Research Institute
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Fleming IslandUnited StatesUnknown status
Elite Research Center
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FlintUnited StatesUnknown status
Aa Mrc Llc
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FlintUnited StatesUnknown status
Velocity Clin Res Gardena
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GardenaUnited StatesUnknown status
Velocity Clin Res Grants Pass
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Grants PassUnited StatesUnknown status
St. Vincent Hosp-Prevea Health
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Green BayUnited StatesUnknown status
Velocity Clinical Research - Greenville
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GreenvilleUnited StatesUnknown status
Nova Health Management & Research Group, PC
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HerndonUnited StatesUnknown status
Indago Research & Health Center, Inc
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HialeahUnited StatesUnknown status
Murphy Research Center
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HumboldtUnited StatesUnknown status
Nat Res Inst Huntington Park
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Huntington ParkUnited StatesUnknown status
MedStar Community Clin Res Ctr
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HyattsvilleUnited StatesUnknown status
Rocky Mt Clin Res, LLC
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Idaho FallsUnited StatesUnknown status
Northeast Res Inst. Inc.
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JacksonvilleUnited StatesUnknown status
Lycoming Internal Medicine Inc
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Jersey ShoreUnited StatesUnknown status
Clinical Investigation Spec. Kenosha
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KenoshaUnited StatesUnknown status
Holston Medical Group.
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KingsportUnited StatesUnknown status
Scripps Whittier Diabetes Inst
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La JollaUnited StatesUnknown status
First Valley Med Grp Lancaster
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LancasterUnited StatesUnknown status
The Research Group of Lexington LLC
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LexingtonUnited StatesUnknown status
Velocity Clin Res Los Angeles
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Los AngelesUnited StatesUnknown status
Norton Healthcare Research Office
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LouisvilleUnited StatesUnknown status
Urban Family Practice Assoc
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MariettaUnited StatesUnknown status
Advanced Med Res Maumee
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MaumeeUnited 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
Velocity Clinical Res Boise
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MeridianUnited StatesUnknown status
Suncoast Clinical Research, Inc.
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MiamiUnited StatesUnknown status
Reyes Clinical Research, Inc
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MiamiUnited StatesUnknown status
Genesis Research Center, LLC
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MiamiUnited StatesUnknown status
New Life Medical
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MiamiUnited StatesUnknown status
San Marcus Res Clin Miami Lakes
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Miami LakesUnited StatesUnknown status
Coastal Carolina Res Ctr
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Mt. PleasantUnited StatesUnknown status
Trial Management Associates
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Myrtle BeachUnited StatesUnknown status
Barnum Medical Research Inc.
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NatchitochesUnited StatesUnknown status
Mid Hudson Med Res-New Windsor
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New WindsorUnited StatesUnknown status
Northport VA Med Ctr Northport
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NorthportUnited StatesUnknown status
Diabetes Assoc. Med Group
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OrangeUnited StatesUnknown status
Clinical Neuroscience Solution
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OrlandoUnited StatesUnknown status
Oviedo Medical Research, LLC
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OviedoUnited StatesUnknown status
MD Medical Research
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Oxon HillUnited StatesUnknown status
Family Clinical Trials
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Pembroke PinesUnited StatesUnknown status
Thomas Jefferson Univ Di Rsrch Ctr
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PhiladelphiaUnited StatesUnknown status
Clinical Research of Philadelphia
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PhiladelphiaUnited StatesUnknown status
CORE - Temple University
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PhiladelphiaUnited StatesUnknown status
Western University of Health Sciences
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PomonaUnited StatesUnknown status
Dominion Medical Associates
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RichmondUnited StatesUnknown status
Endo And Metab Cons
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RockvilleUnited StatesUnknown status
Northeast Research Institute
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Saint AugustineUnited StatesUnknown status
St Johns Center for Clin. Res
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Saint AugustineUnited StatesUnknown status
VIP Trials
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San AntonioUnited StatesUnknown status
Quality Research Inc
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San AntonioUnited StatesUnknown status
DCT-Stone Oak
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San AntonioUnited StatesUnknown status
Briggs Clinical Research, LLC
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San AntonioUnited StatesUnknown status
San Diego Family Care_San Diego
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San DiegoUnited StatesUnknown status
Mills-Peninsula Hlth Services
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San MateoUnited StatesUnknown status
Consano Clinical Research, LLC
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Shavano ParkUnited StatesUnknown status
Velocity Clinical Research Spokane
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SpokaneUnited StatesUnknown status
Encompass Clinical Research_Spring Valley
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Spring ValleyUnited StatesUnknown status
Dwayne O. Williams, M.D., P.A.
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Sugar LandUnited StatesUnknown status
Palmetto Clinical Research
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SummervilleUnited StatesUnknown status
Herman Clinical Research LLC
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SuwaneeUnited 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
Arcturus Healthcare, PLC.
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TroyUnited StatesUnknown status
Velocity Clinical Research Union
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UnionUnited StatesUnknown status
Hillcrest Family Health Center
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WacoUnited StatesUnknown status
Diablo Clinical Research, Inc.
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Walnut CreekUnited StatesUnknown status
Iowa Diab & Endo Res Center
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West Des MoinesUnited StatesUnknown status
Tower Health
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West ReadingUnited StatesUnknown status
Southgate Medical Group, LLP
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West SenecaUnited StatesUnknown status
Accellacare
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WilmingtonUnited StatesUnknown status
Amherst Family Practice P.C.
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WinchesterUnited StatesUnknown status

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