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NCT05259033CompletedPhase 3

A Research Study to See How Well the New Weekly Medicine IcoSema, Which is a Combination of Insulin Icodec and Semaglutide, Controls Blood Sugar Level in People With Type 2 Diabetes Compared to Weekly Semaglutide (COMBINE 2)

A 52 Week Study Comparing the Efficacy and Safety of Once Weekly IcoSema and Once Weekly Semaglutide, Both Treatment Arms With or Without Oral Anti Diabetic Drugs, in Participants With Type 2 Diabetes Inadequately Controlled With a GLP 1 Receptor Agonist. COMBINE 2

Source: ClinicalTrials.gov · Last updated 12 Jun 2026

Brief summary (registry, in English)

This study will compare the new medicine IcoSema, which is a combination of insulin icodec and semaglutide, taken once a week, to semaglutide taken once a week in people with type 2 diabetes. The study will look at how well IcoSema controls blood sugar level in people with type 2 diabetes compared to semaglutide. Participants will either get IcoSema or semaglutide. Which treatment participants get is decided by chance. IcoSema is a new medicine that doctors cannot prescribe. Doctors can already prescribe semaglutide in many countries. Participants will get IcoSema or semaglutide, which they must inject once a week with a pen, which has a small needle, in a skin fold in the thigh, upper arm, or stomach. The study will last for about 1 year and 1 month. Participants will have 18 clinic visits, 34 phone/video calls with the study doctor, and 4 contacts with the site that can either be clinic visits or phone/video calls. At 11 clinic visits participants will have blood samples taken. At 7 clinic visits participants cannot eat or drink (except for water) for 8 hours before the visit. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
683 (actual)
First submitted
10 Feb 2022
Start date
11 Apr 2022
Primary completion date
13 Dec 2023
Lead sponsor
Novo Nordisk A/S
NCT number
NCT05259033

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 683
  • From 11 Apr 2022 to the primary completion date, 13 Dec 2023
  • 191 sites in 15 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.
  • Any episodes (as declared by the participant or in the medical records) of diabetic ketoacidosis within 90 days before screening.
  • Presence or history of pancreatitis (acute or chronic) within 180 days before screening.
  • Any of the following: Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within 180 days before screening.
  • 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

Other illness

  • Chronic heart failure classified as being in New York Heart Association Class IV at screening.

Lab values

  • Anticipated initiation or change in concomitant medication (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, 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 a highly effective contraceptive method.

Who the study is looking for

  • Male or female and age above or equal to 18 years at the time of signing informed consent.
  • Diagnosed with type 2 diabetes mellitus 180 days or more before screening.
  • HbA1c of 7.0 - 10.0% (53.0 - 85.8 mmol/mol) (both inclusive) as assessed by central laboratory on the day of screening.
  • Insulin naïve. The following exceptions are permitted: short term insulin treatment for a maximum of 14 days before screening and/or prior insulin treatment for gestational diabetes.
  • Treated with stable doses of daily or weekly GLP-1 receptor agonist (excluding once weekly semaglutide with doses higher than 1.0 mg) according to local label for the treatment of diabetes for 90 days or more before screening. The treatment can be with or without any of the following anti diabetic drugs with stable doses for 90 days or more before screening: Metformin - Sulfonylureas (Sulfonylureas, meglitinides (glinides) and DPP 4 inhibitors must be discontinued at randomisation) - Meglitinides (glinides)(Sulfonylureas, meglitinides (glinides) and DPP 4 inhibitors must be discontinued at randomisation) - DPP 4 inhibitors (Sulfonylureas, meglitinides (glinides) and DPP 4 inhibitors must be discontinued at randomisation) - Sodium glucose co transporter 2 inhibitors - Alpha-glucosidase inhibitors - Thiazolidinediones - Marketed oral combination products only including the products listed above.
  • Body mass index (BMI) below or equal to 40.0 kg/m\^2.

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

Full criteria on ClinicalTrials.gov

Sites (191)

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

SiteCityCountrySite status
Instituto de Ciências Farmacêuticas de Estudos e Pesquisas
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Aparecida de GoiâniaBrazilUnknown status
Quanta Diagnóstico Nuclear / Medicina Nuclear Alto da XV
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CuritibaBrazilUnknown status
Centro de Diabetes Curitiba
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CuritibaBrazilUnknown status
Centro De Diabetes Metabolismo E Endocrinologia
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FortalezaBrazilUnknown status
Centro de Estudos Em Diabetes E Hipertensão
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FortalezaBrazilUnknown status
Instituto São José dos Campos em Pesquisas Médicas
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São José dos CamposBrazilUnknown status
BR Trials - Ensaios Clínicos e Consultoria Ltda.
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São PauloBrazilUnknown status
ViaCar Recherche Clinique Inc
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BrossardCanadaUnknown status
Dawson Clinical Research
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CambridgeCanadaUnknown status
LMC Clinical Res Thornhill
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ConcordCanadaUnknown status
Medical Trust Clinics, Inc.
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CourticeCanadaUnknown status
Premier Clinical Trial Research Network (PCTRN)
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HamiltonCanadaUnknown status
Wharton Medical Clinic Clinical Trials (Hamilton)
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HamiltonCanadaUnknown status
Western Univ. Cnt for Studies in Fam Med
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LondonCanadaUnknown status
G.A. Research Associates, Ltd.
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MonctonCanadaUnknown status
Recherche GCP Research
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MontrealCanadaUnknown status
LMC Clin Rsrch Inc. (Montreal)
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MontrealCanadaUnknown status
Centre Medical Acadie
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MontrealCanadaUnknown status
Recherche GCP Research_Montreal
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MontrealCanadaUnknown status
Commonwealth Medical Clinic
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Mount PearlCanadaUnknown status
Diex Recherche Québec
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QuébecCanadaUnknown status
Recherche Clinique Sigma inc
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QuébecCanadaUnknown status
LMC Clin Rsrch Inc. (Montreal)
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Saint-LaurentCanadaUnknown status
Ctr Méd. et pro d l'Ost d port
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Saint-Marc-des-CarrieresCanadaUnknown status
Bluewater Clin Res Group Inc
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SarniaCanadaUnknown status
LMC Endo Centres Ltd.(Bayview)
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TorontoCanadaUnknown status
BC Diabetes Canada
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VancouverCanadaUnknown status
St Pauls Hospital
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VancouverCanadaUnknown status
Rivergrove Medical Clinic
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WinnipegCanadaUnknown status
Winnipeg Clinic
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WinnipegCanadaUnknown status
Luzerner Kantonsspital
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LucerneSwitzerlandUnknown status
Kantonsspital Olten
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OltenSwitzerlandUnknown status
Kantonsspital St. Gallen
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Sankt GallenSwitzerlandUnknown status
Diabetes Adipositas Zentrum Zürich
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ZollikerbergSwitzerlandUnknown status
Kinderspital Endokrinologie, Zürich
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ZurichSwitzerlandUnknown status
Peking University People's Hospital-Endocrinology
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BeijingChinaUnknown status
Changzhou No.2 People's Hospital, Yanghu Branch
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ChangzhouChinaUnknown status
Chongqing University Three Gorges Hospital
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ChongqingChinaUnknown status
Anhui Provincial Hospital-Endocrinology
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HefeiChinaUnknown status
Huizhou Central People's Hospital-Endocrinology
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HuizhouChinaUnknown status
Jinan Central Hospital
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JinanChinaUnknown status
The Second Affiliated Hospital of Nanjing Medical University-Endocrinology
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NanjingChinaUnknown status
Shanghai Fifth People's Hospital-Endocrinology
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ShanghaiChinaUnknown status
Shanghai Huashan Hospital, Affiliated to Fudan University
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ShanghaiChinaUnknown status
Huashan Hospital Fudan University-Endocrinology
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ShanghaiChinaUnknown status
Tianjin Medical University General Hospital-Endocrinology
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TianjinChinaUnknown status
Tianjin Medical University Chu Hsien-I Memorial Hospital-Endocrinology
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TianjinChinaUnknown status
Centre Hospitalier Universitaire de Besancon - Hopital Jean Minjoz
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BesançonFranceUnknown status
Centre Hospitalier Universitaire de Rouen - Hopital de Bois Guillaume
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Bois-GuillaumeFranceUnknown status
Les Hopitaux de Chartres-Hopital Louis Pasteur
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Le CoudrayFranceUnknown status
Groupe Sos Sante-Hopital Le Creusot-Hotel Dieu
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Le CreusotFranceUnknown status
Centre Medico Chirurgical Ambroise Pare Hartmann
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Neuilly-Sur-SeineFranceUnknown status
Aphp-Hopital Lariboisiere
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ParisFranceUnknown status
Hospices Civils de Lyon-Hopital Lyon Sud-2
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Pierre-BéniteFranceUnknown status
Centre Hospitalier Universitaire De Nantes - Hôpital Nord Laennec
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Saint-HerblainFranceUnknown status
Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-2
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ToulouseFranceUnknown status
Centre de Recherche Clinique Portes Du Sud
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VénissieuxFranceUnknown status
'G. Gennimatas' General Hospital of Athens
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AthensGreeceUnknown status
Evangelismos Hospital
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AthensGreeceUnknown status
Iatriko Psychicou Private Clinic
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AthensGreeceUnknown status
General Hospital Of Athens Korgialenio Benakio H.R.C. - Department of Endocrinology
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AthensGreeceUnknown status
Univ Gen Hospital Larisa
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LarissaGreeceUnknown status
"Ippokrateio" G.H. of Thessaloniki
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ThessalonikiGreeceUnknown status
"Thermi" Private Hosital
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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
Békés Megyei Központi Kórház - dr. Réthy Pál Tagkórház
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BékéscsabaHungaryUnknown status
Med-Tima Kft
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BudapestHungaryUnknown status
Debreceni Egyetem Klinikai Központ Belgyógyászati Klinika D épület
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DebrecenHungaryUnknown status
Debreceni Egyetem Belgyógyászati Klinika
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DebrecenHungaryUnknown status
PTE-AOK II. Belgyogyaszati Klinika es Nephrologiai Centrum
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PécsHungaryUnknown status
Linn clinic - Diabetes Unit
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HaifaIsraelUnknown status
Clalit sick fund Herzeliya
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HerzeliyaIsraelUnknown status
Wolfson MC - Diabetes Clinic
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HolonIsraelUnknown status
Hadassah Ein Karam MC - Diabetes Unit
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JerusalemIsraelUnknown status
Diabetes Clinic Meir MC
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Kfar SabaIsraelUnknown status
Sheba MC - Endocrinology Clinic
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Tel HaShomerIsraelUnknown status
The Institute of Medical Science, Asahi Life Foundation_Internal Medicine
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Chuo-ku, TokyoJapanUnknown status
Futata Tetsuhiro Clinic Meinohama_Internal medicine
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Fukuoka-shi, FukuokaJapanUnknown status
Futata Tetsuhiro Clinic Meinohama
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Fukuoka-shi, FukuokaJapanUnknown status
Gifu University Hospital_The Third Dept. of Internal Medicine
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GifuJapanUnknown status
Naka Kinen Clinic_Internal medicine
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IbarakiJapanUnknown status
Heiwadai Hospital_Internal Medicine
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MiyazakiJapanUnknown status
Takatsuki Red Cross Hospital_Diabetes and Endocrine Div.
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OsakaJapanUnknown status
Shimizu Clinic Fusa
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SaitamaJapanUnknown status
Soka Sugiura Internal Medicine Clinic_Internal Medicine
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SaitamaJapanUnknown status
Yuri Ono Clinic
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Sapporo-shi, HokkaidoJapanUnknown status
Shinden Higashi Clinic_Internal medicine
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Sendai-shi, MiyagiJapanUnknown status
Irkutsk State Medical Academy of Postgraduate Education
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IrkutskRussiaUnknown status
FSBI 'I.I. Dedov National Medical Research Center of Endocrinology' of the MH of Russia
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MoscowRussiaUnknown status
Limited Law Company "Healthy Family" Medicine Center"
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NovosibirskRussiaUnknown status
BHI of Omsk Region "City Hospital № 3"
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OmskRussiaUnknown status
Penza Regional Clinical Hospital named after N.N.Burdenko
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PenzaRussiaUnknown status
Rostov State Medical University_Rostov-on-Don
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Rostov-on-DonRussiaUnknown status
Polyclinic #2 in Yoshkar-Ola
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Yoshkar-OlaRussiaUnknown status
Primary Care Trial Center, PTC ,Gothia Forum
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GothenburgSwedenUnknown status
Enheten för Kliniska Studier (EKS), Örebro
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ÖrebroSwedenUnknown status
Centrum for Diabetes, Academical Specialist Centrum
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StockholmSwedenUnknown status
HUMAN-CARE, s.r.o.
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KošiceSlovakiaUnknown status
FNsP L. Pasteura
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KošiceSlovakiaUnknown status
DIADAN, s.r.o. Kosice
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KošiceSlovakiaUnknown status
DIOLI s.r.o.
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KošiceSlovakiaUnknown status
DIA - KONTROL s.r.o.
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LeviceSlovakiaUnknown status
Diabetologicka ambulancia SchronerMED, s.r.o.
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Moldava nad BodvouSlovakiaUnknown status
DIABETOL, s.r.o.
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PrešovSlovakiaUnknown status
MUDr. Alena Lomencikova, s.r.o
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Turčianske TepliceSlovakiaUnknown status
Chung Shan Medical University Hospital
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TaichungTaiwanUnknown status
Chi Mei Medical Center
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TainanTaiwanUnknown status
National Cheng Kung University Hospital
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TainanTaiwanUnknown status
Taipei Veterans General Hospital
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TaipeiTaiwanUnknown status
Chang Gung Medical Foundation-Linkou Branch
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TaoyuanTaiwanUnknown status
"University Clinic" of Dnipro State Medical University - Endocrinology department
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DniproUkraineUnknown status
Komisarenko Institute of Endocrinology and Metabolism of NAMSU - Department of paediatric endocrine pathology
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KyivUkraineUnknown status
Centre of Innovative Medical Technologies of NASU - Therapeutic and Endocrinology Department
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KyivUkraineUnknown status
Vinnytsia Regional Clinical Endocrinological Centre - Therapeutic department #2
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VinnytsiaUkraineUnknown status
Javara/Privia Med Grp GA,LLC
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AlbanyUnited StatesUnknown status
Albuquerque Clin Trials, Inc.
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AlbuquerqueUnited StatesUnknown status
Amarillo Med Spec LLP
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AmarilloUnited StatesUnknown status
Texas Diabetes & Endocrinology
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AustinUnited StatesUnknown status
Texas Diab & Endo, P.A.
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AustinUnited StatesUnknown status
AM Diabetes And Endocrinology Center
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BartlettUnited StatesUnknown status
Univ of AL at Birmingham_BRM
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BirminghamUnited StatesUnknown status
Wade Family Medicine
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BountifulUnited StatesUnknown status
Northern Pines Hlth Ctr, PC
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BuckleyUnited StatesUnknown status
Diab & Endo Assoc of Stark Co
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CantonUnited StatesUnknown status
Chattanooga Medical Research, LLC
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ChattanoogaUnited StatesUnknown status
Cedar Crosse Research Center
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ChicagoUnited StatesUnknown status
John Muir Physicians Network
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ConcordUnited StatesUnknown status
Osvaldo A. Brusco MD
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Corpus ChristiUnited StatesUnknown status
North Texas Endocrine Center
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DallasUnited StatesUnknown status
Cedar Research
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DallasUnited StatesUnknown status
UT Southwestern Med Cntr
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DallasUnited StatesUnknown status
Northeast Research Institute
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Fleming IslandUnited StatesUnknown status
Javara Inc. / Privia Medical Group LLC_Forest
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ForestUnited StatesUnknown status
Javara Inc/Privia Md GpLLC Fst
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ForestUnited StatesUnknown status
Diabetes and Thyroid Ctr of FW
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Fort WorthUnited StatesUnknown status
Pri Med Grp dba/Gil Ctr Fam
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GilbertUnited StatesUnknown status
Macoupin Research Group
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GillespieUnited StatesUnknown status
PharmQuest Life Sciences LLC
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GreensboroUnited StatesUnknown status
Encore Medical Research LLC
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HollywoodUnited StatesUnknown status
East West Med Res Inst
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HonoluluUnited StatesUnknown status
Primecare Medical Group
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HoustonUnited StatesUnknown status
MedStar Hlth Res Institute
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HyattsvilleUnited StatesUnknown status
Est Cst Inst for Rsrch,Jksnvil
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JacksonvilleUnited StatesUnknown status
Northeast Res Inst. Inc.
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JacksonvilleUnited StatesUnknown status
Scripps Whittier Diabetes Inst
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La JollaUnited StatesUnknown status
Palm Research Center Inc-Vegas
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Las VegasUnited StatesUnknown status
John J Shelmet, MD
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LawrencevilleUnited StatesUnknown status
Clinical Trials Research_Sacramento
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LincolnUnited StatesUnknown status
DCOL Ctr for Clin Res
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LongviewUnited StatesUnknown status
Downtown LA Res Ctr. Inc.
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Los AngelesUnited StatesUnknown status
Velocity Clin Res Wstlke
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Los AngelesUnited StatesUnknown status
Velocity Clin Res Los Angeles
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Los AngelesUnited StatesUnknown status
L-MARC Research Center
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LouisvilleUnited StatesUnknown status
ActivMed Practice & Research LLC
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MethuenUnited StatesUnknown status
University of Miami
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MiamiUnited StatesUnknown status
South Broward Research LLC
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MiramarUnited StatesUnknown status
Adult Medicine of Lake County, Inc.
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Mt. DoraUnited StatesUnknown status
Saltzer Medical Group Research
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NampaUnited StatesUnknown status
Southern New Hampshire Diabete
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NashuaUnited StatesUnknown status
TPMG Clinical Research
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Newport NewsUnited StatesUnknown status
Valley Clinical Trials, Inc.
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NorthridgeUnited StatesUnknown status
Univ of Nebraska Medical CTR
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OmahaUnited StatesUnknown status
Clinical Neuroscience Solution
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OrlandoUnited StatesUnknown status
Florida Institute for Clinical Research
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OrlandoUnited StatesUnknown status
Oviedo Medical Research, LLC
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OviedoUnited StatesUnknown status
Four Rivers Clinical Research Inc
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PaducahUnited StatesUnknown status
Thomas Jefferson Univ Di Rsrch Ctr
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PhiladelphiaUnited StatesUnknown status
Phoenician Centers for Research & Innovation PCRI
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PhoenixUnited StatesUnknown status
Endo Res Solutions Inc
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RoswellUnited StatesUnknown status
Texas Diabetes & Endocrinology_Round Rock
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Round RockUnited StatesUnknown status
NE Clin Res of San Antonio
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San AntonioUnited StatesUnknown status
San Diego Family Care_San Diego
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San DiegoUnited StatesUnknown status
Hillcrest Clinical Research
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SimpsonvilleUnited StatesUnknown status
Endeavor Health
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SkokieUnited StatesUnknown status
Ileana J Tandron APMC
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SlidellUnited StatesUnknown status
Endocrine Associates of Long Island, PC
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SmithtownUnited StatesUnknown status
Central Illinois Diabetes and Clinical Research
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SpringfieldUnited StatesUnknown status
Chrysalis Clinical Research
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St. GeorgeUnited StatesUnknown status
Sugar Lakes Family Practice, PA
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Sugar LandUnited StatesUnknown status
Palmetto Clinical Research
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SummervilleUnited StatesUnknown status
Clinical Research Institute of Arizona
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Sun City WestUnited StatesUnknown status
Premier Medical Center, Inc.
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Toluca LakeUnited StatesUnknown status
Cotton O'Neil Diab & Endo Ctr
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TopekaUnited StatesUnknown status
Velocity Clin. Res Valparaiso
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ValparaisoUnited StatesUnknown status
Hillcrest Family Health Center
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WacoUnited StatesUnknown status
New Venture Medical Research
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WadsworthUnited StatesUnknown status
Iowa Diab & Endo Res Center
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West Des MoinesUnited StatesUnknown status
Metabolic Research Institute, Inc
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West Palm BeachUnited StatesUnknown status
Southgate Medical Group, LLP
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West SenecaUnited StatesUnknown status
Accellacare
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WilmingtonUnited StatesUnknown status

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