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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-522170-36-00 | EU Trial (CTIS) Number | ||
| I4V-MC-JAJK | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to find out if baricitinib can preserve beta-cell function in participants newly diagnosed with type 1 diabetes. Participation in the study will last about 60 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Baricitinib | Experimental | Participants will receive baricitinib orally |
|
| Placebo | Placebo Comparator | Participants will receive placebo orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baricitinib | Drug | Administered orally |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in C-peptide Area Under the Curve (AUC) | Baseline, Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Hemoglobin A1c (HbA1c) | Baseline, Week 52 | |
| Change from Baseline in Number of Manual Insulin Boluses | Baseline, Week 52 | |
| Rate of Clinically Significant Hypoglycemic Events |
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Inclusion Criteria:
Have a new diagnosis of type 1 diabetes within 100 days prior to starting study intervention
Have at least one diabetes-related autoantibody found at screening
Show signs of remaining beta-cell function
Weigh at least 8 kilograms (kg) (18 pounds) at screening
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or | Contact | 317-615-4559 | LillyTrials@Lilly.com | |
| Physicians interested in becoming principal investigators please contact | Contact | clinical_inquiry_hub@lilly.com |
| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barbara Davis Center for Childhood Diabetes | Not yet recruiting | Aurora | Colorado | 80045 | United States |
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| Label | URL |
|---|---|
| A Study of Baricitinib (LY3009104) to Preserve Beta Cell Function in Children and Adults Newly Diagnosed With Type 1 Diabetes (BARICADE-PRESERVE) | View source |
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Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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| Placebo | Drug | Administered orally |
|
| Baseline through Week 52 |
| Change from Baseline in Fasting C-Peptide | Baseline, Week 52 |
| Change from Baseline in Height | Baseline, Week 52 |
| Change from Baseline in Mean Total Daily Insulin Dose | Measured during the two weeks prior to the assessment | Baseline, Week 52 |
| Change from Baseline in Short Form 36 Version 2 Health Survey, Acute (SF-36v2) | Baseline, Week 52 |
| Change from Baseline in Matsuda Index | Baseline, Week 52 |
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Baricitinib | Predose through Week 16 |
| Tallahassee Memorial HealthCare | Not yet recruiting | Tallahassee | Florida | 32308 | United States |
|
| Children's Hospital of Philadelphia (CHOP) | Not yet recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| Driscoll Children's Hospital | Not yet recruiting | Corpus Christi | Texas | 78411 | United States |
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| University of Virginia | Recruiting | Charlottesville | Virginia | 22903 | United States |
|
| Women's and Children's Hospital | Recruiting | Adelaide | 5006 | Australia |
|
| Centre for Children's Health Research | Not yet recruiting | Brisbane | 4101 | Australia |
|
| Austin Health - Repatriation Hospital | Recruiting | Heidelberg West | 3081 | Australia |
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| Ipswich Hospital | Recruiting | Ipswich | 4305 | Australia |
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| Royal Children's Hospital | Not yet recruiting | Melbourne | 3052 | Australia |
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| Southern Adelaide Diabetes & Endocrine Services | Recruiting | Oaklands Park | 5046 | Australia |
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| The Royal Melbourne Hospital | Recruiting | Parkville | 3050 | Australia |
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| Perth Children's Hospital | Recruiting | Perth | 6009 | Australia |
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| Sydney Children's Hospital | Recruiting | Randwick | 2031 | Australia |
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| The Children's Hospital at Westmead | Recruiting | Westmead | 2145 | Australia |
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| Université Libre de Bruxelles - Hôpital Erasme | Not yet recruiting | Brussels | 1070 | Belgium |
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| UZ Brussel | Not yet recruiting | Brussels | 1090 | Belgium |
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| Cliniques universitaires Saint-Luc | Not yet recruiting | Brussels | 1200 | Belgium |
|
| Antwerp University Hospital | Not yet recruiting | Edegem | 2650 | Belgium |
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| UZ Gent | Recruiting | Ghent | 9000 | Belgium |
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| UZ Leuven | Not yet recruiting | Leuven | 3000 | Belgium |
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| Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman | Not yet recruiting | Liège | 4000 | Belgium |
|
| CHU UCL Namur/Site Sainte Elisabeth | Not yet recruiting | Namur | 5000 | Belgium |
|
| Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godinne | Not yet recruiting | Yvoir | 5530 | Belgium |
|
| Hospital Universitário Maria Aparecida Pedrossian | Recruiting | Campo Grande | 79080-190 | Brazil |
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| Quanta Diagnóstico e Terapia | Recruiting | Curitiba | 80045170 | Brazil |
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| Centro de Diabetes Curitiba | Recruiting | Curitiba | 80810-040 | Brazil |
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| Centro De Diabetes Metabolismo E Endocrinologia | Recruiting | Fortaleza | 60175-047 | Brazil |
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| Cendi - Endocrinologia e Diabetes | Recruiting | Goiânia | 74230-035 | Brazil |
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| Centro de Pesquisa ClÃnica de MarÃlia - CPCLIM | Recruiting | MarÃlia | 17504-072 | Brazil |
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| Instituto da Crianca com Diabetes | Recruiting | Porto Alegre | 91350-250 | Brazil |
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| Hospital das ClÃnicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (USP) - HCFM -T | Not yet recruiting | Ribeirão Preto | 14051-140 | Brazil |
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| Universidade Federal do Rio de Janeiro | Recruiting | Rio de Janeiro | 21941-590 | Brazil |
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| Instituto de Pesquisa Clinica | Recruiting | São Paulo | 01223-001 | Brazil |
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| CPCLIN | Recruiting | São Paulo | 01228-200 | Brazil |
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| IBTED - Tecnologia e Educação em Diabetes | Recruiting | São Paulo | 04038-032 | Brazil |
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| ClÃnica Hepatogastro JK | Recruiting | São Paulo | 04077-020 | Brazil |
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| Hospital das Clinicas FMUSP | Recruiting | São Paulo | 05403-000 | Brazil |
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| CEDOES | Recruiting | Vitória | 29055450 | Brazil |
|
| Alberta Children's Hospital | Not yet recruiting | Calgary | T3B 6A8 | Canada |
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| CIUSSS- saguenay-Lac-Saint-Jean | Not yet recruiting | Chicoutimi | G7H 5H6 | Canada |
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| Alberta Diabetes Institute | Not yet recruiting | Edmonton | T6G 2E1 | Canada |
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| St. Joseph's Health Care | Not yet recruiting | London | N6A 4V2 | Canada |
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| Centricity Research Ottawa LMC Endocrinology | Recruiting | Ottawa | K2J 0V2 | Canada |
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| CHUL et Centre mère-enfant Soleil | Not yet recruiting | Québec | G1V 4G2 | Canada |
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| BC Diabetes Office | Recruiting | Vancouver | V5Y 3W2 | Canada |
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| Nemocnice Jihlava | Recruiting | Jihlava | 58633 | Czechia |
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| Fakultni nemocnice Ostrava | Recruiting | Ostrava | 70852 | Czechia |
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| Milan Kvapil s.r.o., Diabetologicka ambulance | Recruiting | Prague | 14900 | Czechia |
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| New Children's Hospital | Not yet recruiting | Helsinki | 00029 | Finland |
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| Oulun yliopistollinen sairaala | Recruiting | Oulu | 90220 | Finland |
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| Tampereen yliopistollinen sairaala | Recruiting | Tampere | 33520 | Finland |
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| Turku University Hospital | Recruiting | Turku | 20520 | Finland |
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| Hospices Civils de Lyon - Hopital Louis Pradel | Not yet recruiting | Bron | 69677 | France |
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| Centre Hospitalier Sud Francilien | Not yet recruiting | Corbeil-Essonnes | 91106 | France |
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| Centre Hospitalier Universitaire de Grenoble | Not yet recruiting | Grenoble | 38700 | France |
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| Hopital Claude Huriez - CHU de Lille | Not yet recruiting | Lille | 59037 | France |
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| Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone | Not yet recruiting | Marseille | 13385 | France |
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| Pitie Salpetriere University Hospital | Not yet recruiting | Paris | 75013 | France |
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| Hôpital Universitaire Necker Enfants Malades | Not yet recruiting | Paris | 75015 | France |
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| Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universitaire (C -T | Not yet recruiting | Paris | 75019 | France |
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| CHU Rangueil | Not yet recruiting | Toulouse | 31059 | France |
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| Hannoversche Kinderheilanstalt | Not yet recruiting | Hanover | 30173 | Germany |
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| Schwerpunktpraxis für Diabetes Hormone & Stoffwechsel | Recruiting | Hof | 95030 | Germany |
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| Klinikum Karlsburg | Not yet recruiting | Karlsburg | 17495 | Germany |
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| Diabetologikum Ludwigshafen/Die Praxis am Ludwigsplatz | Recruiting | Ludwigshafen am Rhein | 67059 | Germany |
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| TUM Klinikum | Recruiting | München | 80939 | Germany |
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| RED-Institut GmbH | Recruiting | Oldenburg | 23758 | Germany |
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| Asklepios Klinik Sankt Augustin | Recruiting | Sankt Augustin | 53757 | Germany |
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| Universitaetsklinikum Ulm | Recruiting | Ulm | 89075 | Germany |
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| Yitzhak Shamir Medical Center | Recruiting | Beer Yaacov | 70300 | Israel |
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| Soroka Medical Center | Recruiting | Beersheba | 8410101 | Israel |
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| Rambam Health Care Campus | Recruiting | Haifa | 3109601 | Israel |
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| Linn Medical Center | Recruiting | Haifa | 3515209 | Israel |
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| Institute of Diabetes, Technology and Research - Clalit Health | Recruiting | Herzliya | 4600201 | Israel |
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| Hadassah Medical Center | Recruiting | Jerusalem | 9112001 | Israel |
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| Meir Medical Center | Recruiting | Kfar Saba | 4428164 | Israel |
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| Schneider Children's Medical Center | Recruiting | Petah Tikva | 4920235 | Israel |
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| Rabin Medical Center | Recruiting | Petah Tikva | 4941492 | Israel |
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| Sheba Medical Center | Recruiting | Ramat Gan | 5262100 | Israel |
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| Sourasky Medical Center | Recruiting | Tel Aviv | 6423906 | Israel |
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| Ospedale Pediatrico Salesi | Not yet recruiting | Ancona | 60123 | Italy |
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| Azienda Ospedaliera Universitaria Careggi | Recruiting | Florence | 50134 | Italy |
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| Azienda Ospedaliera Universitaria Meyer IRCCS | Recruiting | Florence | 50139 | Italy |
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| Azienda Ospedaliera Universitaria Di Messina G. Martino | Recruiting | Messina | 98125 | Italy |
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| Ospedale San Raffaele | Not yet recruiting | Milan | 20132 | Italy |
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| University of Naples Federico II | Recruiting | Naples | 80131 | Italy |
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| Azienda Ospedaliero Universitaria Maggiore della Carità | Recruiting | Novara | 28100 | Italy |
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| Azienda Ospedale - Università Padova | Not yet recruiting | Padova | 35128 | Italy |
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| Azienda Ospedale - Università Padova | Not yet recruiting | Padova | 35128 | Italy |
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| Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento | Recruiting | Verona | 37126 | Italy |
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| Saitama Medical University Hospital | Not yet recruiting | Iruma | 350-0495 | Japan |
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| Diabeter - Rotterdam | Not yet recruiting | Rotterdam | 3011 TA | Netherlands |
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| Helse Fonna - Haugesund Sjukehus | Recruiting | Haugesund | 5528 | Norway |
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| Akershus Universitetssykehus | Recruiting | Lørenskog | 1478 | Norway |
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| Oslo Universitetssykehus Aker | Recruiting | Oslo | 0316 | Norway |
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| Oslo Universitetssykehus Ullevål | Recruiting | Oslo | 0450 | Norway |
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| Stavanger Universitetssykehus | Recruiting | Stavanger | 4011 | Norway |
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| St. Olavs Hospital | Recruiting | Trondheim | 7030 | Norway |
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| Uniwersyteckie Centrum Kliniczne | Recruiting | Gdansk | 80-952 | Poland |
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| UMED Clinical Trials | Recruiting | Lodz | 92-213 | Poland |
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| MTZ Clinical Research Powered by Pratia | Recruiting | Warsaw | 02-172 | Poland |
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| Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu | Recruiting | Wroclaw | 50-368 | Poland |
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| 2Ca Braga | Recruiting | Braga | 4710-243 | Portugal |
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| Centro Materno Infantil do Norte | Not yet recruiting | Porto | 4050 | Portugal |
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| ULSAM - Hospital de Santa Luzia | Recruiting | Viana do Castelo | 4900-858 | Portugal |
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| Unidade Local De Saude De Gaia/Espinho E.P.E. | Not yet recruiting | Vila Nova de Gaia | 4434-502 | Portugal |
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| OSI Ezkerraldea-Enkarterri-Cruces - Hospital Universitario Cruces | Recruiting | Barakaldo | 48903 | Spain |
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| Hospital ClÃnic de Barcelona | Recruiting | Barcelona | 08036 | Spain |
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| Hospital de la Santa Creu i Sant Pau | Recruiting | Barcelona | 08041 | Spain |
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| Hospital Sant Joan de Déu | Recruiting | Esplugues de Llobregat | 08950 | Spain |
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| Hospital Universitario Ramón y Cajal | Recruiting | Madrid | 28034 | Spain |
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| Hospital Universitario Marqués de Valdecilla | Recruiting | Santander | 39008 | Spain |
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| Hospital Universitario Virgen Del Rocio | Recruiting | Seville | 41013 | Spain |
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| Hospital Universitario Virgen Del Rocio | Recruiting | Seville | 41013 | Spain |
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| Hospital Universitari i Politecnic La Fe | Recruiting | Valencia | 46026 | Spain |
|
| ProbarE i Lund AB | Not yet recruiting | Lund | 222 22 | Sweden |
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| Universitetssjukhuset Örebro | Recruiting | Örebro | 701 85 | Sweden |
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| Östersunds Sjukhus | Not yet recruiting | Östersund | 831 31 | Sweden |
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| ProbarE i Stockholm AB | Recruiting | Stockholm | 11437 | Sweden |
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| Uddevalla Sjukhus | Not yet recruiting | Uddevalla | 451 53 | Sweden |
|
| Institute of Endocrinology and Metabolism named after Komissarenko | Recruiting | Kiev | 04114 | Ukraine |
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| Kyiv City Endocrinological Center | Recruiting | Kyiv | 01024 | Ukraine |
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| Zakarpattia Endoclinic | Recruiting | Uzhhorod | 88000 | Ukraine |
|
| Vinnytsia Regional Clinical Endocrinology Dispensary | Recruiting | Vinnytsia | 21010 | Ukraine |
|
| Aberdeen Royal Infirmary | Recruiting | Aberdeen | AB25 2ZN | United Kingdom |
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| Queen Elizabeth Hospital Birmingham | Recruiting | Birmingham | B15 2TH | United Kingdom |
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| Birmingham Children's Hospital | Not yet recruiting | Birmingham | B4 6NH | United Kingdom |
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| Southmead Hospital | Recruiting | Bristol | BS10 5NB | United Kingdom |
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| Addenbrooke's Hospital | Recruiting | Cambridge | CB2 2QQ | United Kingdom |
|
| University Hospital of Wales | Recruiting | Cardiff | CF14 4XW | United Kingdom |
|
| Churchill Hospital | Recruiting | Oxford | OX3 7LE | United Kingdom |
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| Southampton General Hospital | Recruiting | Southampton | SO16 6YD | United Kingdom |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000596027 | baricitinib |
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