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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-521797-34-00 | EU Trial (CTIS) Number | ||
| I4V-MC-JAJJ | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to find out if baricitinib can delay the onset of clinical type 1 diabetes (T1D) in people who are at high risk to develop T1D. Participation in the study will last up to approximately 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Baricitinib | Experimental | Participants will receive baricitinib orally |
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| Placebo | Placebo Comparator | Participants will receive placebo orally |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baricitinib | Drug | Administered orally |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Time from Baseline to Diagnosis of Stage 3 Type 1 Diabetes | Baseline up to approximately 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Glucose-Stimulated C-peptide Area Under the Curve (AUC) | Baseline, Week 52 | |
| Change from Baseline in Glucose AUC | Baseline, Week 52 | |
| Change from Baseline in AUC Ratio (AUC C-peptide/AUC Glucose × 1000) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or | Contact | 1-317-615-4559 | 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 |
|---|---|---|---|---|---|---|
| Tallahassee Memorial HealthCare | Not yet recruiting | Tallahassee | Florida | 32308 | United States |
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| Label | URL |
|---|---|
| A Study of Baricitinib (LY3009104) for the Delay of Stage 3 Type 1 Diabetes in At-Risk Children and Adults (BARICADE-DELAY) | 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, Week 52 |
| Change from Baseline in Height | Baseline, Week 52 |
| Change from Baseline in Body Mass Index (BMI) Percentile | Baseline, Week 52 |
| Change in Glucose Time in Range Between 70 and 180 mg/dL (inclusive) | Baseline, Week 52 |
| Change from Baseline in Short Form 36 Version 2 Health Survey, Acute (SF-36v2) | Baseline, Week 52 |
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Baricitinib | Predose through Week 24 |
| PK: Area Under the Concentration Versus Time Curve (AUC) of Baricitinib | Predose through Week 24 |
| Change from Baseline in Matsuda Index | Baseline, Week 52 |
| University of South Florida | Suspended | Tampa | Florida | 33612 | United States |
| University of Iowa | Not yet recruiting | Iowa City | Iowa | 52242 | United States |
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| Iowa Diabetes and Endocrinology Research Center | Recruiting | West Des Moines | Iowa | 50266 | United States |
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| Novak Center for Children's Health | Not yet recruiting | Louisville | Kentucky | 40202 | United States |
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| Children's Hospital of Philadelphia (CHOP) | Not yet recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| University of Virginia | Recruiting | Charlottesville | Virginia | 22903 | United States |
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| Women's and Children's Hospital | Recruiting | Adelaide | 5006 | Australia |
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| Box Hill Hospital | Recruiting | Box Hill | 3128 | Australia |
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| Royal Brisbane and Women's Hospital | Recruiting | Brisbane | 4029 | Australia |
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| Centre for Children's Health Research | Not yet recruiting | Brisbane | 4101 | Australia |
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| Royal Children's Hospital | Not yet recruiting | Melbourne | 3052 | 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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| UZ Brussel | Not yet recruiting | Brussels | 1090 | Belgium |
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| Cliniques universitaires Saint-Luc | Not yet recruiting | Brussels | 1200 | Belgium |
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| Antwerp University Hospital | Not yet recruiting | Edegem | 2650 | Belgium |
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| UZ Leuven | Recruiting | Leuven | 3000 | Belgium |
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| CHU UCL Namur/Site Sainte Elisabeth | Not yet recruiting | Namur | 5000 | Belgium |
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| Freire Pesquisa Clínica | Recruiting | Belo Horizonte | 30150-320 | Brazil |
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| Centro de Diabetes Curitiba | Recruiting | Curitiba | 80810-040 | Brazil |
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| Hospital Universitario Walter Cantidio | Recruiting | Fortaleza | 60430-270 | Brazil |
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| Cendi - Endocrinologia e Diabetes | Recruiting | Goiânia | 74230-035 | Brazil |
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| Centro de Pesquisa Clínica de Marília - CPCLIM | Recruiting | Marília | 17504-072 | 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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| Hospital das Clinicas FMUSP | Recruiting | São Paulo | 05403-000 | Brazil |
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| Alberta Diabetes Institute | Not yet recruiting | Edmonton | T6G 2E1 | Canada |
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| BC Diabetes Office | Recruiting | Vancouver | V5Y 3W2 | Canada |
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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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| 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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| Hopitaux Universitaires Paris Centre-Hopital Cochin | Not yet recruiting | Paris | 75014 | 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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| Klinik Josefinum | Not yet recruiting | Augsburg | 86154 | Germany |
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| Universitaetsklinikum Augsburg | Recruiting | Augsburg | 86156 | Germany |
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| Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden | Not yet recruiting | Dresden | 01307 | Germany |
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| Hannoversche Kinderheilanstalt | Recruiting | Hanover | 30173 | Germany |
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| TUM Klinikum | Recruiting | München | 80939 | 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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| Carmel Hospital | Not yet recruiting | Haifa | 3436212 | 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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| Sheba Medical Center | Not yet recruiting | Ramat Gan | 5262100 | Israel |
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| Kaplan Medical Center | Recruiting | Rehovot | 7610001 | Israel |
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| Sourasky Medical Center | Recruiting | Tel Aviv | 6423906 | Israel |
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| Ospedale Pediatrico Salesi | Recruiting | Ancona | 60123 | Italy |
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| IRCCS - AOU di Bologna | Recruiting | Bologna | 40138 | Italy |
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| Ospedale Microcitemico | Not yet recruiting | Cagliari | 09121 | Italy |
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| Azienda Ospedaliera Universitaria Meyer IRCCS | Recruiting | Florence | 50139 | 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 | 80100 | 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 Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento | Recruiting | Verona | 37126 | Italy |
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| Abeno Medical Clinic | Recruiting | Abeno | 545-0052 | Japan |
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| Saitama Medical University Hospital | Recruiting | Iruma | 350-0495 | Japan |
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| Nippon Medical School Musashi Kosugi Hospital | Recruiting | Kawasaki | 211-8533 | Japan |
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| Yamanashi Prefectural Central Hospital | Recruiting | Kofu | 400-8506 | Japan |
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| Seino Internal Medicine Clinic | Recruiting | Kōriyama | 963-8851 | Japan |
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| Jinnouchi Hospital | Recruiting | Kumamoto | 862-0976 | Japan |
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| Nagano Municipal Hospital | Recruiting | Nagano | 381-8551 | Japan |
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| Nakakinen clinic | Recruiting | Naka | 311-0113 | Japan |
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| Niigata University Medical & Dental Hospital | Recruiting | Niigata | 951-8520 | Japan |
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| Diabeter - Rotterdam | Not yet recruiting | Rotterdam | 3011 TA | Netherlands |
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| Haukeland Universitetssjukehus | Recruiting | Bergen | 5021 | Norway |
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| Akershus Universitetssykehus | Recruiting | Lørenskog | 1478 | Norway |
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| Oslo Universitetssykehus Ullevål | Recruiting | Oslo | 0450 | Norway |
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| Oslo Universitetssykehus Aker | Recruiting | Oslo | 0586 | Norway |
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| Stavanger Universitetssykehus | Recruiting | Stavanger | 4011 | Norway |
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| MTZ Clinical Research Powered by Pratia | Not yet recruiting | Warsaw | 02-172 | Poland |
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| Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś | Recruiting | Warsaw | 04-501 | Poland |
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| 2Ca Braga | Recruiting | Braga | 4710-243 | Portugal |
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| Unidade Local de Saude de Matosinhos | Recruiting | Matosinhos Municipality | 4464-513 | 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 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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| Skånes Universitetssjukhus Malmö | Recruiting | Malmö | 21428 | Sweden |
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| Universitetssjukhuset Örebro | Recruiting | Örebro | 701 85 | Sweden |
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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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| Addenbrooke's Hospital | Recruiting | Cambridge | CB2 2QQ | United Kingdom |
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| Noah's Ark Children's Hospital for Wales | Recruiting | Cardiff | CF14 4XW | United Kingdom |
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| University Hospital of Wales | Recruiting | Cardiff | CF14 4XW | United Kingdom |
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| Queen Elizabeth University Hospital | Not yet recruiting | Glasgow | G51 4TF | United Kingdom |
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| Royal London Hospital | Recruiting | London | E1 1BB | United Kingdom |
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| St. George's Hospital | Recruiting | London | SW17 0QT | United Kingdom |
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| The John Radcliffe Hospital | Recruiting | Oxford | OX3 9DU | 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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