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ClinicalTrials.gov public records Last synced Oct 2, 2026, 5:18 AM EDT

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Showing 1–24 of 46 matching trials from the live ClinicalTrials.gov search.
Filters: Condition: New-onset Type 1 Diabetes Mellitus Clear all
Not yet recruiting Phase 3 Interventional

PRISE (Personalized Response and Immunologic Surveillance of Endogenous C-Peptide Preservation in New, Recent, and Established Onset Type 1 Diabetes Treated With Human Anti-Thymocyte Globulin [h-ATG]) Study

NCT07670650
View directory record Official record
Conditions
Type 1 Diabetes (T1D)
Interventions
SAB-142, Placebo
Drug
Lead sponsor
University of Florida
Other
Eligibility
5 Years to 40 Years
Enrollment
108 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2030
U.S. locations
4
States / cities
San Francisco, California • Aurora, Colorado • Gainesville, Florida + 1 more
Source: ClinicalTrials.gov public record
Updated Jun 26, 2026 · Synced Oct 2, 2026, 5:18 AM EDT
Completed Phase 2 Interventional Results available

Autoimmunity-blocking Antibody for Tolerance in Recently Diagnosed Type 1 Diabetes

NCT00129259
View directory record Official record
Conditions
Diabetes Mellitus, Type 1
Interventions
Anti-CD3 mAb, Diabetes Standard of Care Treatment, Iron supplementation
Biological · Other · Dietary Supplement
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Eligibility
8 Years to 30 Years
Enrollment
83 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2005 – 2011
U.S. locations
7
States / cities
San Francisco, California • Denver, Colorado • New Haven, Connecticut + 3 more
Source: ClinicalTrials.gov public record
Updated May 22, 2017 · Synced Oct 2, 2026, 5:18 AM EDT
Completed Phase 2 Interventional Results available

Atorvastatin in New Onset Type 1 Diabetes Mellitus (T1DM)

NCT00529191
View directory record Official record
Conditions
Type 1 Diabetes
Interventions
Atorvastatin, Placebo
Drug · Other
Lead sponsor
Children's Hospital of Philadelphia
Other
Eligibility
10 Years to 19 Years
Enrollment
40 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2013
U.S. locations
1
States / cities
Philadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Mar 13, 2017 · Synced Oct 2, 2026, 5:18 AM EDT
Recruiting Phase 2 Interventional

Rezpegaldesleukin (NKTR-358) in New Onset Type 1 Diabetes Mellitus

NCT07142252
View directory record Official record
Conditions
Type 1 Diabetes Mellitus
Interventions
Rezpegaldesleukin, Placebo
Drug
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Eligibility
8 Years to 45 Years
Enrollment
66 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2028
U.S. locations
14
States / cities
San Francisco, California • Aurora, Colorado • New Haven, Connecticut + 11 more
Source: ClinicalTrials.gov public record
Updated Sep 8, 2026 · Synced Oct 2, 2026, 5:18 AM EDT
Terminated Phase 2 Interventional Results available

Novel Therapy to Preserve Beta Cell Function in New Onset Type 1 Diabetes

NCT00837759
View directory record Official record
Conditions
Diabetes Mellitus Type 1, Autoimmune Diabetes
Interventions
Insulin, Lansoprazole, Sitagliptin, Diamyd, GAD65 (Diamyd)
Drug · Biological
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Eligibility
16 Years to 30 Years
Enrollment
7 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2011
U.S. locations
1
States / cities
Bethesda, Maryland
Source: ClinicalTrials.gov public record
Updated Jan 3, 2013 · Synced Oct 2, 2026, 5:18 AM EDT
Active, not recruiting No phase listed Observational

Recent-Onset Type 1 Diabetes Extension Study Evaluating the Long-Term Safety of Teplizumab (PROTECT Extension)

NCT04598893
View directory record Official record
Conditions
Diabetes Mellitus, Type 1
Interventions
Teplizumab, Placebo
Biological · Other
Lead sponsor
Provention Bio, a Sanofi Company
Industry
Eligibility
9 Years to 19 Years
Enrollment
188 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2026
U.S. locations
25
States / cities
San Diego, California • San Francisco, California • Walnut Creek, California + 22 more
Source: ClinicalTrials.gov public record
Updated Dec 9, 2025 · Synced Oct 2, 2026, 5:18 AM EDT
Completed Phase 3 Interventional Results available

Hybrid Closed Loop Therapy and Verapamil for Beta Cell Preservation in New Onset Type 1 Diabetes

NCT04233034
View directory record Official record
Conditions
Type1 Diabetes
Interventions
HCL, verapamil 120mg tablet, non-HCL, placebo
Device · Drug
Lead sponsor
Jaeb Center for Health Research
Other
Eligibility
7 Years to 17 Years
Enrollment
113 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2022
U.S. locations
6
States / cities
Palo Alto, California • Aurora, Colorado • New Haven, Connecticut + 3 more
Source: ClinicalTrials.gov public record
Updated Nov 27, 2024 · Synced Oct 2, 2026, 5:18 AM EDT
Completed Not applicable Interventional

Low Dose Cyclosporin and Methotrexate Therapy in Diabetes

NCT00905073
View directory record Official record
Conditions
Type 1 Diabetes Mellitus
Interventions
cyclosporin and methotrexate
Drug
Lead sponsor
Georgetown University
Other
Eligibility
8 Years to 18 Years
Enrollment
8 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
1990 – 1994
U.S. locations
1
States / cities
Washington D.C., District of Columbia
Source: ClinicalTrials.gov public record
Updated Apr 13, 2011 · Synced Oct 2, 2026, 5:18 AM EDT
Completed Phase 1 Interventional

MER3101: MAS-1 Adjuvanted Antigen-specific Immunotherapeutic for Prevention and Treatment of Type 1 Diabetes

NCT03624062
View directory record Official record
Conditions
Type 1 Diabetes Mellitus
Interventions
MAS-1 adjuvanted Insulin B-chain
Drug
Lead sponsor
University of Colorado, Denver
Other
Eligibility
18 Years to 45 Years
Enrollment
21 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2025
U.S. locations
1
States / cities
Aurora, Colorado
Source: ClinicalTrials.gov public record
Updated Feb 13, 2026 · Synced Oct 2, 2026, 5:18 AM EDT
Active, not recruiting Phase 2 Interventional

Repeat BCG Vaccinations for the Treatment of New Onset Type 1 Diabetes in Children Age 8-<18 Years

NCT05866536
View directory record Official record
Conditions
Diabetes Mellitus, Type 1 Diabetes, Diabetes type1, Autoimmune Diabetes
Interventions
Bacillus Calmette-Guérin, Saline Injection
Biological
Lead sponsor
Massachusetts General Hospital
Other
Eligibility
8 Years to 17 Years
Enrollment
100 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2031
U.S. locations
1
States / cities
Charlestown, Massachusetts
Source: ClinicalTrials.gov public record
Updated Jun 26, 2026 · Synced Oct 2, 2026, 5:18 AM EDT
Terminated Phase 2 Interventional Results available

Study of Secukinumab in Patients With Newly-diagnosed Type 1 Diabetes Mellitus

NCT02044848
View directory record Official record
Conditions
Type 1 Diabetes Mellitus
Interventions
Secukinumab, Placebo
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years to 35 Years
Enrollment
5 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014
U.S. locations
2
States / cities
New York, New York • Seattle, Washington
Source: ClinicalTrials.gov public record
Updated Feb 17, 2016 · Synced Oct 2, 2026, 5:18 AM EDT
Completed No phase listed Observational

Hybrid Closed Loop Therapy and Verapamil for Beta Cell Preservation in New Onset Type 1 Diabetes (CLVer): Extension Study

NCT06177691
View directory record Official record
Conditions
Type1 Diabetes
Interventions
Not listed
Lead sponsor
Jaeb Center for Health Research
Other
Eligibility
7 Years to 17 Years
Enrollment
77 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2026
U.S. locations
6
States / cities
Palo Alto, California • Aurora, Colorado • New Haven, Connecticut + 3 more
Source: ClinicalTrials.gov public record
Updated Sep 24, 2026 · Synced Oct 2, 2026, 5:18 AM EDT
Completed Phase 2 Interventional Results available

At-Risk for Type 1 Diabetes Extension Study (TN-10 Extension)

NCT04270942
View directory record Official record
Conditions
Diabetes Mellitus, Type 1
Interventions
teplizumab 1 mg/mL
Drug
Lead sponsor
Provention Bio, a Sanofi Company
Industry
Eligibility
Not listed
Enrollment
6 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2024
U.S. locations
8
States / cities
Aurora, Colorado • New Haven, Connecticut • Gainesville, Florida + 1 more
Source: ClinicalTrials.gov public record
Updated Feb 12, 2025 · Synced Oct 2, 2026, 5:18 AM EDT
Recruiting Phase 1Phase 2 Interventional

A Randomized Phase 1/2 Trial of Low Dose Anti-thymocyte Globulin (ATG) With Subsequent Adalimumab or Verapamil in New Onset Type 1 Diabetes

NCT07061574
View directory record Official record
Conditions
Type 1 Diabetes, New Onset
Interventions
Anti-thymocyte globulin (ATG), verapamil extended-release capsule, Adalimumab
Drug
Lead sponsor
City of Hope Medical Center
Other
Eligibility
9 Years to 20 Years
Enrollment
120 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2031
U.S. locations
10
States / cities
San Francisco, California • New Haven, Connecticut • Gainesville, Florida + 7 more
Source: ClinicalTrials.gov public record
Updated Sep 2, 2026 · Synced Oct 2, 2026, 5:18 AM EDT
Withdrawn Phase 2 Interventional

Diabetes Autoimmunity Withdrawn in New Onset Patients (DAWN)

NCT03794973
View directory record Official record
Conditions
Diabetes Mellitus, Type 1
Interventions
TOL-3021, TOL-3021 Placebo
Biological · Other
Lead sponsor
Tolerion, Inc.
Industry
Eligibility
12 Years to 35 Years
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2023
U.S. locations
1
States / cities
Miami, Florida
Source: ClinicalTrials.gov public record
Updated Dec 8, 2020 · Synced Oct 2, 2026, 5:18 AM EDT
Terminated Phase 2 Interventional Results available

Study of Antithymocyte Globulin for Treatment of New-onset T1DM

NCT00515099
View directory record Official record
Conditions
New-onset Type 1 Diabetes Mellitus
Interventions
Antithymocyte globulin, Placebo
Drug
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Eligibility
12 Years to 35 Years
Enrollment
58 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2013
U.S. locations
9
States / cities
Los Angeles, California • Oakland, California • San Diego, California + 6 more
Source: ClinicalTrials.gov public record
Updated May 11, 2017 · Synced Oct 2, 2026, 5:18 AM EDT
Completed Phase 2 Interventional Results available

Canakinumab Study in Individuals With Newly Diagnosed Type 1 Diabetes

NCT00947427
View directory record Official record
Conditions
Type 1 Diabetes, Preservation of Insulin Secretion, Newly Diagnosed Type 1 Diabetes, Canakinumab in Type 1 Diabetes
Interventions
canakinumab (anti IL-1beta), Placebo
Drug
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Eligibility
6 Years to 45 Years
Enrollment
71 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2013
U.S. locations
11
States / cities
San Francisco, California • Stanford, California • New Haven, Connecticut + 8 more
Source: ClinicalTrials.gov public record
Updated May 6, 2020 · Synced Oct 2, 2026, 5:18 AM EDT
Completed Phase 2 Interventional Results available

Rituximab in New Onset Type 1 Diabetes

NCT00279305
View directory record Official record
Conditions
Type 1 Diabetes Mellitus
Interventions
Anti-CD20 (rituximab), Placebo Comparator
Drug
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Eligibility
8 Years to 45 Years
Enrollment
87 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2005 – 2009
U.S. locations
13
States / cities
Los Angeles, California • San Francisco, California • Stanford, California + 10 more
Source: ClinicalTrials.gov public record
Updated May 6, 2020 · Synced Oct 2, 2026, 5:18 AM EDT
Terminated Phase 2 Interventional Results available

Inducing Remission in Type 1 Diabetes With Alefacept

NCT00965458
View directory record Official record
Conditions
New-onset Type 1 Diabetes Mellitus
Interventions
Alefacept, Placebo
Biological · Drug
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Eligibility
12 Years to 35 Years
Enrollment
49 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2014
U.S. locations
15
States / cities
Tucson, Arizona • Los Angeles, California • San Francisco, California + 12 more
Source: ClinicalTrials.gov public record
Updated Jul 6, 2017 · Synced Oct 2, 2026, 5:18 AM EDT
Active, not recruiting Phase 2 Interventional

Reducing Innate Inflammation in New Onset Type 1 Diabetes

NCT04335656
View directory record Official record
Conditions
Type 1 Diabetes, type1diabetes, Type 1 Diabetes Mellitus
Interventions
Lactiplantibacillus plantarum, Placebo
Dietary Supplement · Other
Lead sponsor
Medical College of Wisconsin
Other
Eligibility
3 Years to 45 Years
Enrollment
60 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2027
U.S. locations
1
States / cities
Milwaukee, Wisconsin
Source: ClinicalTrials.gov public record
Updated Mar 16, 2026 · Synced Oct 2, 2026, 5:18 AM EDT
Completed Phase 3 Interventional Results available

Trial of Otelixizumab for Adults With Newly Diagnosed Type 1 Diabetes Mellitus (Autoimmune): DEFEND-1

NCT00678886
View directory record Official record
Conditions
Diabetes Mellitus, Type 1
Interventions
otelixizumab infusion plus physician determined standard of care, placebo infusion plus physician determined standard of care
Biological
Lead sponsor
GlaxoSmithKline
Industry
Eligibility
12 Years to 45 Years
Enrollment
272 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2012
U.S. locations
67
States / cities
Birmingham, Alabama • Little Rock, Arkansas • Costa Mesa, California + 58 more
Source: ClinicalTrials.gov public record
Updated Oct 3, 2017 · Synced Oct 2, 2026, 5:18 AM EDT
Completed Phase 2 Interventional Results available

Tocilizumab (TCZ) in New-onset Type 1 Diabetes

NCT02293837
View directory record Official record
Conditions
Type 1 Diabetes Mellitus, New-onset Type 1 Diabetes Mellitus, T1DM, T1D
Interventions
Tocilizumab (TCZ), Placebo, Standard of Care
Drug · Other
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Eligibility
6 Years to 17 Years
Enrollment
136 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2020
U.S. locations
17
States / cities
San Francisco, California • Stanford, California • New Haven, Connecticut + 14 more
Source: ClinicalTrials.gov public record
Updated Sep 8, 2021 · Synced Oct 2, 2026, 5:18 AM EDT
Completed Phase 2 Interventional Results available

Intravenous CTLA4-lg Treatment in Recent Onset Type 1 Diabetes Mellitus

NCT00505375
View directory record Official record
Conditions
Type 1 Diabetes Mellitus
Interventions
CTLA-4 Ig, Placebo
Drug · Other
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Eligibility
6 Years to 45 Years
Enrollment
112 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2012
U.S. locations
12
States / cities
Los Angeles, California • San Francisco, California • Stanford, California + 9 more
Source: ClinicalTrials.gov public record
Updated May 6, 2020 · Synced Oct 2, 2026, 5:18 AM EDT
Completed Phase 2 Interventional Results available

Effects of Recombinant Human Glutamic Acid Decarboxylase on the Progression of Type 1 Diabetes in New Onset Subjects

NCT00529399
View directory record Official record
Conditions
Type 1 Diabetes Mellitus
Interventions
GAD-Alum, GAD-Alum and Aluminum hydroxide, Aluminum hydroxide
Drug
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Eligibility
3 Years to 45 Years
Enrollment
145 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2012
U.S. locations
14
States / cities
Los Angeles, California • Palo Alto, California • San Francisco, California + 11 more
Source: ClinicalTrials.gov public record
Updated May 7, 2020 · Synced Oct 2, 2026, 5:18 AM EDT