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DIPIT
WithdrawnPhase 1, PHASE2Diabetes Islet Preservation Immune Treatment
A Pilot, Safety and Feasibility Trial of Anti-Thymocyte Globulin (ATG), Low Dose Interleukin-2 (IL-2), Adalimumab and Exenatide in the Treatment of New-Onset Type 1 Diabetes
Lead sponsor
Asset
Exenatide
Subcutaneous · GLP-1 agonist
Listed sites
0
Recruiting sites
—
Enrollment
—
actual
Study population
Type 1 diabetes
Key I/E criterion
—
Primary endpoints
•C-peptide AUC•Proportion of regulatory T cells
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Subject must be able to understand and provide informed consent.
2. Males and females, 18-35 years of age.
3. New onset T1D for no longer than 120 days at the time of randomization.
4. Affected by T1D, according to ADA standard criteria, and confirmed by positivity of at least one T1D-associated autoantibody, to GAD65, IA-2, ZnT8, or insulin autoantibodies (if patient has been treated with insulin for less than 2 weeks).
5. Being on insulin therapy.
6. Stimulated C-peptide peak level >0.2 nmol/L at the baseline 1 visit MMTT.
7. Female subjects of childbearing potential must have a negative pregnancy test upon study entry.
8. Female (and male) subjects with reproductive potential must agree to use two FDA approved methods of birth control for the entire duration of the study.
9. Adequate venous access to support study required blood draws.
Exclusion criteria
1. Inability or unwillingness of a participant to give written informed consent or comply with study protocol.
2. BMI>30 Kg/m2.
3. Contra-indications to ATG, GCSF, exenatide, etanercept and IL-2 (as per package insert, e.g., knowledge of hypersensitivity to drugs or its excipients).
4. Uncompensated heart failure, fluid overload, myocardial infarction or liver disease or severe impairment of a vital organ within the last 6 weeks before enrollment.
5. Any of the following laboratory findings: hemoglobin <10.0 g/dL; leukocytes <3,000/μL; neutrophils <1,500/μL; lymphocytes <800/μL; platelets <100,000/μL.
6. Any sign or diagnosis of significant chronic active infection (e.g., hepatitis, tuberculosis, EBV, or CMV), or screening laboratory evidence consistent with a significant chronic active infection (such as positive for HIV, IGRA test for TB, or hepatitis B-C).
7. Ongoing acute infections, e.g., acute respiratory tract urinary tract, or gastrointestinal tract infections.
8. Ongoing or anticipated use of diabetes medications other than insulin.
9. Current or ongoing use of non-insulin pharmaceuticals that affect glycemic control within prior 7 days of screening.
10. Current or prior use of immunomodulators or systemic steroids in the last 2 months that could potentially affect diabetes or immunologic status.
11. Recent recipient of any licensed or investigational live attenuated vaccine(s) within 6 weeks of randomization.
12. Use of investigational drugs within 3 months of participation.
13. Concomitant therapy with immunosuppressive drugs, immunomodulators, or cytotoxic agents, or previous therapy less than 3 months from randomization.
14. History or diagnosis of malignancy. Any history of gastroparesis or other severe gastrointestinal disease, pancreatitis, thyroid nodules or malignancy with the exception of a history of localized basal cell carcinoma.
15. Presence of an allograft.
16. AST, ALT or Alkaline Phosphatase >2 times upper limit of normal or total bilirubin >1.5 times upper limit of normal.
17. Current, diagnosed, mental illness or current, diagnosed or self-reported drug or alcohol abuse; or any situation that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements.
18. Pregnancy or ongoing breastfeeding for women; unwillingness or inability of both females and males of childbearing age to use a reliable and effective form of contraception, for the entire duration of the study.
19. Past or current medical problems, or findings from physical examination, or laboratory testing, that are not listed above which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained.
Endpoints (6)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Glycemic / diabetes
4 endpointsSimulated C-peptide AUC
Time frame:1 Year Visit
C-peptide AUC
descriptive, improvement
Hemoglobin A1c (HbA1c) levels
Time frame:Up to 18 months
descriptive, improvement
LOINC 4548-4
Insulin dose
Time frame:Up to 18 months
change from baseline, improvement
Mean daily plasma glucose levels
Time frame:Up to 18 months
descriptive, improvement
Safety / tolerability / PK
1 endpointIncidence of immune response adverse events
Time frame:Up to 18 months
event count, event
Other (unclassified)
1 endpointProportion of regulatory T cells
Time frame:1 Year Visit
descriptive
Publications (2)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.