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NCT07076199Active, not recruitingPhase 3

A Research Study to See How a Weekly Insulin, Insulin Icodec, Helps in Reducing the Blood Sugar Compared to Daily Insulin Glargine, Both in Combination With Insulin Aspart, in Adults With Type 1 Diabetes

A 26-week Study Comparing the Efficacy and Safety of Once-weekly Insulin Icodec and Once-daily Insulin Glargine U100, Both in Combination With Insulin Aspart, in Adults With Type 1 Diabetes

Source: ClinicalTrials.gov · Last updated 25 Sept 2026

Brief summary (registry, in English)

This study compares insulin icodec, an insulin taken once a week to insulin glargine, an insulin taken once a day. The study medicine will be investigated in participants with type 1 diabetes. The study will look at how well insulin icodec taken weekly controls blood sugar compared to insulin glargine taken daily. The study will last for about 8.5 months.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
877 (estimated)
First submitted
14 Jul 2025
Start date
11 Aug 2025
Primary completion date
25 Jan 2027
Lead sponsor
Novo Nordisk A/S
NCT number
NCT07076199
EU CT number
2024-519945-31-00
EudraCT number
2024-519945-31

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 877
  • From 11 Aug 2025 to the primary completion date, 25 Jan 2027
  • 178 sites in 8 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

  • Previous participation in this study. Participation is defined as signed informed consent.

Other illness

  • Known or suspected hypersensitivity to study intervention(s) or related products.
  • Any condition, except for conditions associated with type 1 diabetes mellitus, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.

Lab values

  • Anticipated initiation or anticipated change in concomitant medications (for more than 15 consecutive days) known to affect weight or glucose metabolism (e.g., treatment with thyroid hormones, or systemic corticosteroids).

Other

  • Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method.
  • Exposure to an investigational medicinal product within 90 days or 5 half-lives of the investigational medicinal product (if known), whichever is longer, before screening.
  • Known hypoglycaemic unawareness as indicated by the Investigator according to Clarke's questionnaire question.
  • Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator.

Who the study is looking for

  • Diagnosed with type 1 diabetes mellitus greater than or equal to (≥) 1 year before screening.
  • Treated with multiple daily insulin injections (daily basal insulin analogue and bolus insulin analogue regimen) ≥ 6 months before screening.
  • HbA1c from 7.0-10.0 percentage (%) (53.0-85.8 millimoles per mole (mmol/mol)), both inclusive, at screening confirmed by central laboratory analysis.
  • Ability and willingness to adhere to the protocol including performance of self-measured plasma glucose (SMPG) profiles, based on the investigator's judgement.

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

Full criteria on ClinicalTrials.gov

Sites (178)

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

SiteCityCountrySite status
St Vincent's Hospital Melbourne - Endocrinology & Diabetes Department
Coordinator of this site? Confirm its status
FitzroyAustraliaUnknown status
Austin Health, Metabolic Disorders Centre
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Heidelberg HeightsAustraliaUnknown status
Macquarie University - Clinical Trials Unit
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Macquarie ParkAustraliaUnknown status
Southern Adelaide Diabetes & Endocrine Services
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Oaklands ParkAustraliaUnknown status
The Royal Melbourne Hospital - Diabetes & Endocrinology Department
Coordinator of this site? Confirm its status
ParkvilleAustraliaUnknown status
Townsville University Hospital
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TownsvilleAustraliaUnknown status
Illawarra Diabetes Service Clinical Trials & Research Unit
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WollongongAustraliaUnknown status
Centricity Research Brampton Endocrinology
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BramptonCanadaUnknown status
University Of Calgary
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CalgaryCanadaUnknown status
Centricity Research Calgary Endocrinology
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CalgaryCanadaUnknown status
Centricity Research Etobicoke Endocrinology
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EtobicokeCanadaUnknown status
Nova Scotia Health Authority
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HalifaxCanadaUnknown status
Premier Clinical Trial Research Network (PCTRN)
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HamiltonCanadaUnknown status
Ctr de recherche Clinique de Laval
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LavalCanadaUnknown status
Western University Centre for Studies in Fam Med
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LondonCanadaUnknown status
Centricity Research Mirabel
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MirabelCanadaUnknown status
McGill University Health Centre
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MontrealCanadaUnknown status
Clinique Endocrinologie OASIS.
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MontrealCanadaUnknown status
Clinique des Maladies Lipidiques de Quebec Inc.
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QuébecCanadaUnknown status
Centre de Medecine Metabolique de Lanaudiere
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TerrebonneCanadaUnknown status
Centricity Research Toronto LMC Multispec
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TorontoCanadaUnknown status
Centricity Research LMC (Toronto)
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TorontoCanadaUnknown status
Vancouver General Hospital_Vancouver_0
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VancouverCanadaUnknown status
Winnipeg Clinic
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WinnipegCanadaUnknown status
MVZ DiaMedicum Bad Mergentheim GmbH
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Bad MergentheimGermanyActive, not recruiting
Herz Und Diabeteszentrum NRW Bad Oeynhausen Universitaetsklinik Der Ruhr-Universitaet Bochum
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Bad OeynhausenGermanyActive, not recruiting
Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR
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BerlinGermanyActive, not recruiting
DSP Diabetes- und Stoffwechselpraxis Bochum
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BochumGermanyActive, not recruiting
Technische Universitaet Dresden
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DresdenGermanyActive, not recruiting
Praxis für Diabetologie, Angiologie und Innere Medizin Eisenach
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EisenachGermanyActive, not recruiting
InnoDiab Forschung Gmbh
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EssenGermanyActive, not recruiting
MVZ Diabeteszentrum Dr. Tews GmbH
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GelnhausenGermanyActive, not recruiting
Diabetes Zentrum Wilhelmsburg GbR
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HamburgGermanyActive, not recruiting
Diabeteszentrum Hamburg West
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HamburgGermanyActive, not recruiting
Diabetes Zentrum Wandsbek Diabetologische Schwerpunktpraxis Berufsausuebungsgemeinschaft GbR
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HamburgGermanyActive, not recruiting
Die Praxis am Ludwigsplatz
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LudwigshafenGermanyActive, not recruiting
Schwerpunktpraxis für Diabetes und Ernährungsmedizin
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MünsterGermanyActive, not recruiting
Institut für Diabetesforschung Osnabrück
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OsnabrückGermanyActive, not recruiting
Zentrum für klinische Studien Alexander Segner
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St. Ingbert-OberwürzbachGermanyActive, not recruiting
Zentrum für klinische Forschung Allgäu-Oberschwaben
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WangenGermanyActive, not recruiting
Centrum Medyczne INTERCOR Sp. z o.o.
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BydgoszczPolandActive, not recruiting
Medyczne Centrum Diabetologiczno-Endokrynologiczno-Metaboliczne Diab-Endo-Met Sp. z o.o.
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CracowPolandActive, not recruiting
Beata Miklaszewicz & Dariusz Dabrowski Cardiamed Sp. j.
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LegnicaPolandActive, not recruiting
Gabinet Lekarski Malgorzata Saryusz-Wolska
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LodzPolandActive, not recruiting
Reumed Sp. z o.o.
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LublinPolandActive, not recruiting
Zanamed Medical Clinic Sp. z o.o.
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LublinPolandActive, not recruiting
Formed 2 Sp. z o.o.
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OswiecimPolandActive, not recruiting
Irmed Klimkiewicz Rudziewicz-Kowalska sp. j.
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Piotrkow TrybunalskiPolandActive, not recruiting
Uniwersyteckie Centrum Stomatologii i Medycyny Specjalistycznej Sp. z o.o.
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PoznanPolandActive, not recruiting
Metabolica Sp. z o.o.
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TarnówPolandActive, not recruiting
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji
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WarsawPolandActive, not recruiting
Zespół Wojewódzkich Przychodni Specjalistycznych w Katowicach
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ZabrzePolandActive, not recruiting
Etg Zamosc Sp. z o.o.
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ZamośćPolandActive, not recruiting
Centro de Endo Altagracia
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BayamónPuerto RicoUnknown status
Advanced Clinical Research, LLC
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BayamónPuerto RicoUnknown status
Sc Cmi Dr. Pletea Noemi S.R.L.
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BacauRomaniaActive, not recruiting
Minimed S.R.L.
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BacauRomaniaActive, not recruiting
Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L.
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BrasovRomaniaActive, not recruiting
Diabs&Nutricare S.R.L.
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BucharestRomaniaActive, not recruiting
Nutrilife S.R.L.
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BucharestRomaniaActive, not recruiting
Spitalul Clinic Judetean De Urgenta Sfantul Apostol Andrei Constanta
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ConstanțaRomaniaActive, not recruiting
Top Diabet S.R.L.
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CraiovaRomaniaActive, not recruiting
Diamed Obesity S.R.L.
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GalatiRomaniaActive, not recruiting
Dianutrilife Medica S.R.L.
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PloiestiRomaniaActive, not recruiting
Diabmed Dr. Popescu Alexandrina S.R.L.
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PloiestiRomaniaActive, not recruiting
Clinica Korall S.R.L.
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Satu MareRomaniaActive, not recruiting
Spitalul Clinic Judetean de Urgenta Sibiu
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SibiuRomaniaActive, not recruiting
Spitalul Judetean de Urgenta "Sfantul Ioan cel Nou" Suceava
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SuceavaRomaniaActive, not recruiting
Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara
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TimisoaraRomaniaActive, not recruiting
DIABEDA s.r.o.
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BratislavaSlovakiaActive, not recruiting
Diabint s.r.o.
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BytcaSlovakiaActive, not recruiting
DIADAN, s.r.o. Kosice
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KošiceSlovakiaActive, not recruiting
Human-Care s.r.o.
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Kosice 1SlovakiaActive, not recruiting
Dioli s.r.o.
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Kosice - SeverSlovakiaActive, not recruiting
Medispektrum s.r.o.
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PetrzalkaSlovakiaActive, not recruiting
AMC Community Endocrinology
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AlbanyUnited StatesUnknown status
Albuquerque Clinical Trials, Inc.
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AlbuquerqueUnited StatesUnknown status
Amarillo Medical Specialists
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AmarilloUnited StatesUnknown status
Atlanta Diabetes Associates
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AtlantaUnited StatesUnknown status
Texas Diab Endo ATX N Mopac EXPR
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AustinUnited StatesUnknown status
Texas Diabetes & Endocrinology
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AustinUnited StatesUnknown status
Brigham & Women's Hospital
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BostonUnited StatesUnknown status
Holston Medical Group_Bristol
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BristolUnited StatesUnknown status
Diab & Endo Assoc of Stark Co
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CantonUnited StatesUnknown status
University Diabetes & Endocrine Consultants
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ChattanoogaUnited StatesUnknown status
Northwestern University
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ChicagoUnited StatesUnknown status
University of Chicago
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ChicagoUnited StatesUnknown status
Profound Research LLC
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ClarkstonUnited StatesUnknown status
Cleveland Clinic - Cleveland
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ClevelandUnited StatesUnknown status
The Ohio State University Medical Center
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ColumbusUnited StatesUnknown status
Centricity Research Columbus
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ColumbusUnited StatesUnknown status
John Muir Health
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ConcordUnited StatesUnknown status
Cullman Clinical Trials
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CullmanUnited StatesUnknown status
Velocity Clinical Res-Dallas
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DallasUnited StatesUnknown status
Alliance Clinical Network
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DallasUnited StatesUnknown status
North Texas Endocrine Center
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DallasUnited StatesUnknown status
Research Institute Of Dallas
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DallasUnited StatesUnknown status
Thyroid Endocrinology & Diabetes PA
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DallasUnited StatesUnknown status
Precision Endo - Revival
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DentonUnited StatesUnknown status
Epic Medical Research
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DeSotoUnited StatesUnknown status
Frontier Medical Ctr
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El PasoUnited StatesUnknown status
Denver Endocrinology Diabetes and Thyroid Center
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EnglewoodUnited StatesUnknown status
Headlands Research California, LLC
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EscondidoUnited StatesUnknown status
Profound Research, LLC
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Farmington HillsUnited StatesUnknown status
Northeast Research Institute
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Fleming IslandUnited StatesUnknown status
Elite Clinical Research Center
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FlintUnited StatesUnknown status
N. Texas Diab & Endo - Prime
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Flower MoundUnited StatesUnknown status
Diabetes and Thyroid Center of Fort Worth
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Fort WorthUnited StatesUnknown status
Clinical Res of Central Ca
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FresnoUnited StatesUnknown status
Providence Medical Foundation
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FullertonUnited StatesUnknown status
Optumcare Clinical Trials,LLC-Golden
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GoldenUnited StatesUnknown status
Prevea Health
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Green BayUnited StatesUnknown status
Prisma Health Endo Spc Thy Ctr
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GreenvilleUnited StatesUnknown status
Physicians East Endocrinology
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GreenvilleUnited StatesUnknown status
Encore Medical Research LLC
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HollywoodUnited StatesUnknown status
Amir Ali Hassan, MD, PA
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HoustonUnited StatesUnknown status
Houston Endocrinology Center
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HoustonUnited StatesUnknown status
The Endocrine Center
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HoustonUnited StatesUnknown status
Rocky Mt Clin Res, LLC
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Idaho FallsUnited StatesUnknown status
Indiana Uni School of Med-Ped
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IndianapolisUnited StatesUnknown status
Northeast Research Institute
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JacksonvilleUnited StatesUnknown status
Scripps Whittier Diabetes Inst
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La JollaUnited StatesUnknown status
Palm Research Center Inc
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Las VegasUnited StatesUnknown status
Physicians Research Assoc. LLC
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LawrencevilleUnited StatesUnknown status
Loma Linda University Faculty Medical Clinics
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Loma LindaUnited StatesUnknown status
Pacific Clinical Studies
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Los AlamitosUnited StatesUnknown status
Los Angeles Institute for Metabolic Research
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Los AngelesUnited StatesUnknown status
Robley Rex VA Medical Center
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LouisvilleUnited StatesUnknown status
RGV Endocrine Center
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McAllenUnited StatesUnknown status
Tekton Research
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McKinneyUnited StatesUnknown status
Life Spring Research Foundation, LLC
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MiamiUnited StatesUnknown status
International Diabetes Center
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MinneapolisUnited StatesUnknown status
Centricity Rsrch MHCity Multi
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Morehead CityUnited StatesUnknown status
Vanderbilt Medical Center_Nashville
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NashvilleUnited StatesUnknown status
MidState Endocrine Associates
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NashvilleUnited StatesUnknown status
Centricity Res New Bern Multispeciality
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New BernUnited StatesUnknown status
Suncoast Clinical Research, Inc.
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New Port RicheyUnited StatesUnknown status
NYC Research Inc.
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New YorkUnited StatesUnknown status
NYU Langone Orthopedic Center
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New YorkUnited StatesUnknown status
Lynn Institute of Norman
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NormanUnited StatesUnknown status
Alliance for Multispecialty Research
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NormanUnited StatesUnknown status
West Orange Endocrinology
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OcoeeUnited StatesUnknown status
Rio Clinical Trials
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OgdenUnited StatesUnknown status
Lynn Institute - East OKC
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Oklahoma CityUnited StatesUnknown status
MedStar Health Research Institute
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OlneyUnited StatesUnknown status
University of Nebraska Medical Center
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OmahaUnited StatesUnknown status
QCR Network
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OmahaUnited StatesUnknown status
Suncoast Clinical Research, Inc.
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Palm HarborUnited StatesUnknown status
Pasadena Clinical Trials
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PasadenaUnited StatesUnknown status
Center for Diab,Obes & Metab
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Pembroke PinesUnited StatesUnknown status
SRA Trials-Broward
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Pembroke PinesUnited StatesUnknown status
Thomas Jefferson University Hospital
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PhiladelphiaUnited StatesUnknown status
WestenU Health
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PomonaUnited StatesUnknown status
Hanson Clinical Research Center
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Port CharlotteUnited StatesUnknown status
Accellacare of Raleigh
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RaleighUnited StatesUnknown status
Rainier Clin Res Ctr Inc
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RentonUnited StatesUnknown status
Mayo Clinic
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RochesterUnited StatesUnknown status
Endocrine Research Solutions, Inc
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RoswellUnited StatesUnknown status
Be Well Clinical Studies
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Round RockUnited StatesUnknown status
Texas Diabetes & Endocrinology_Round Rock
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Round RockUnited StatesUnknown status
Northeast Clinical Research of San Antonio
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San AntonioUnited StatesUnknown status
Alliance Clinical Network
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San DiegoUnited StatesUnknown status
Mills Health Center
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San MateoUnited StatesUnknown status
Center for Endocrine DM and Metabolic Disorders
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Santa ClaritaUnited StatesUnknown status
Endeavor Health
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SkokieUnited StatesUnknown status
UVM Endocrinology
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South BurlingtonUnited StatesUnknown status
Washington University
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St LouisUnited StatesUnknown status
Saint Louis University
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St LouisUnited StatesUnknown status
Latin Clinical Trial Ctr
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TamaracUnited StatesUnknown status
Bayside Clinical Research
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TampaUnited StatesUnknown status
Cotton O'Neil Diabetes & Endocrinology
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TopekaUnited StatesUnknown status
University Clin Investigators
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TustinUnited StatesUnknown status
Diablo Clinical Research, Inc.
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Walnut CreekUnited StatesUnknown status
Valley Diab. & Endo Comp Ctr
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WeslacoUnited StatesUnknown status
Iowa Diabetes Research
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West Des MoinesUnited StatesUnknown status
Metabolic Research Institute, Inc
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West Palm BeachUnited StatesUnknown status
University at Buffalo
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WilliamsvilleUnited StatesUnknown status
Accellacare - Wilmington
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WilmingtonUnited StatesUnknown status

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