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Diabetes Mellitus, Type 1Phase 1/2DIPITNCT02586831

Diabetes Islet Preservation Immune Treatment

A Phase 1/2 study testing Anti-Thymocyte Globulin (ATG), Interleukin 2 and Exenatide in people with Diabetes Mellitus, Type 1 and Hypoglycemia, run by Camillo Ricordi and Jay Skyler.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

To assess whether there is a difference in endogenous insulin secretion, measured as stimulated C-peptide secretion (area under the curve during a 4-hour mixed meal tolerance test), at the 1 year visit, for study subjects receiving combinational therapy versus those receiving placebo. Read more about this study

Who is it for?
Ages 18 to 35 years
What is being tested?
Anti-Thymocyte Globulin (ATG), Interleukin 2 and Exenatide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
No sites listed yet
Study dates
1 Jun 2024to 1 Jun 2024
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Patients must meet all of the following criteria to be eligible to participate in this study:
  • Subject must be able to understand and provide informed consent.
  • Males and females, 18-35 years of age.
  • New onset T1D for no longer than 120 days at the time of randomization.
  • 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).
  • Being on insulin therapy.
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  • Stimulated C-peptide peak level >0.2 nmol/L at the baseline 1 visit MMTT.
  • Female subjects of childbearing potential must have a negative pregnancy test upon study entry.
  • 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.
  • Adequate venous access to support study required blood draws.

Who cannot join

  • Potential participants must not meet any of the following exclusion criteria:
  • Inability or unwillingness of a participant to give written informed consent or comply with study protocol.
  • BMI>30 Kg/m2.
  • Contra-indications to ATG, GCSF, exenatide, etanercept and IL-2 (as per package insert, e.g., knowledge of hypersensitivity to drugs or its excipients).
  • Uncompensated heart failure, fluid overload, myocardial infarction or liver disease or severe impairment of a vital organ within the last 6 weeks before enrollment.
  • 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.
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  • 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).
  • Ongoing acute infections, e.g., acute respiratory tract urinary tract, or gastrointestinal tract infections.
  • Ongoing or anticipated use of diabetes medications other than insulin.
  • Current or ongoing use of non-insulin pharmaceuticals that affect glycemic control within prior 7 days of screening.
  • Current or prior use of immunomodulators or systemic steroids in the last 2 months that could potentially affect diabetes or immunologic status.
  • Recent recipient of any licensed or investigational live attenuated vaccine(s) within 6 weeks of randomization.
  • Use of investigational drugs within 3 months of participation.
  • Concomitant therapy with immunosuppressive drugs, immunomodulators, or cytotoxic agents, or previous therapy less than 3 months from randomization.
  • 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.
  • Presence of an allograft.
  • AST, ALT or Alkaline Phosphatase >2 times upper limit of normal or total bilirubin >1.5 times upper limit of normal.
  • 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.
  • 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.
  • 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.

About this study

Official title: 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

To assess whether there is a difference in endogenous insulin secretion, measured as stimulated C-peptide secretion (area under the curve during a 4-hour mixed meal tolerance test), at the 1 year visit, for study subjects receiving combinational therapy versus those receiving placebo. The study will also examine the effect of the proposed treatments on immunological outcomes, specifically proportion of regulatory T cells at the 1 year visit.

Being tested
Anti-Thymocyte Globulin (ATG), Interleukin 2, Exenatide, Adalimumab, ATG Placebo
Medical subject headings
Diabetes Mellitus, Type 1, Hypoglycemia, Autoimmune Diseases, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Anti-Thymocyte Globulin (ATG)Drug

    Also called Thymoglobulin

    2.5 mg/kg administered as two divided infusions of 0.5 mg/kg and 2 mg/kg on Days 1 and 2.

  • Interleukin 2Drug

    Also called Aldesleukin; IL-2 or Proleukin®

    1 million IU per dose administered subcutaneously for 5 consecutive days on Days 10-14, and then every two weeks.

  • ExenatideDrug

    Also called Bydureon®

    2 mg administered subcutaneously weekly for up to 52 weeks.

  • AdalimumabDrug

    Also called HUMIRA®

    50 mg administered subcutaneously once a month for 1 year.

  • ATG PlaceboOther

    ATG placebo mimicking Thymoglobulin administered intravenously.

  • IL-2 PlaceboOther

    IL-2 placebo mimicking Aldesleukin administered subcutaneously.

  • Adalimumab PlaceboOther

    Placebo mimicking Adalimumab administered subcutaneously.

  • Exenatide PlaceboOther

    Placebo mimicking Exenatide administered subcutaneously.

Study groups in NCT02586831
Study groupRoleWhat they receive
Arm AExperimentalParticipants in this group will receive Thymoglobulin, Aldesleukin, Adalimumab, and Exenatide over a period of 52 weeks. * Anti-Thymocyte Globulin (ATG or Thymoglobulin®) will be administered at a dose of 2.5mg/kg (2 infusions, 0.5 and 2mg/kg) Days 1 and 2 * Adalimumab (Humira®) will be administered at a dose of 50 mg every month, for 1 year * Low-dose Interleukin 2 (Aldesleukin; IL-2 or Proleukin®) will be administered 1 million IU/dose; 5 consecutive days (days 10-14), \& then every 2 weeks, for 52 weeks * Exenatide (Bydureon®): 2 mg SC weekly up to 52 weeks.
Receives: Drug: Anti-Thymocyte Globulin (ATG); Drug: Interleukin 2; Drug: Exenatide; Drug: Adalimumab
Arm BPlacebo comparatorParticipants in this group will receive the placebos for Thymoglobulin, Aldesleukin, Adalimumab, Exenatide, and Neulasta over a period of 52 weeks.
Receives: Other: ATG Placebo; Other: IL-2 Placebo; Other: Adalimumab Placebo; Other: Exenatide Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Simulated C-peptide AUC

    Endogenous insulin secretion as measured as stimulated C-peptide section Area Under the Curve (AUC) during a 4 hour mixed meal tolerance test (MMTT)

    Measured: 1 Year Visit

  2. Proportion of regulatory T cells

    As measured from blood samples

    Measured: 1 Year Visit

Secondary outcomes (4)

  1. Hemoglobin A1c (HbA1c) levels

    Measure of glycemic control as evaluated by HbA1c levels from blood samples

    Measured: Up to 18 months

  2. Insulin dose

    Measure of glycemic control as evaluated by insulin dose

    Measured: Up to 18 months

  3. Mean daily plasma glucose levels

    Measure of glycemic control as evaluated by the mean daily plasma glucose levels from blood samples

    Measured: Up to 18 months

  4. Incidence of immune response adverse events

    Incidence of immune response adverse events as assessed by treating physician

    Measured: Up to 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2015 (estimated)
  2. Study start1 Jun 2024 (estimated)
  3. Primary completion1 Jun 2024
  4. Study completion1 Jun 2024

Why it stopped: Study withdrawn prior to enrollment due to funding issues

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02586831
Sponsor's protocol ID
20150856
Acronym
DIPIT
Status last verified
Jan 2026
First submitted
23 Oct 2015
Last updated
15 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Skyler JS. Prevention and reversal of type 1 diabetes--past challenges and future opportunities. Diabetes Care. 2015 Jun;38(6):997-1007. doi: 10.2337/dc15-0349.

    PubMed 25998292

  • Skyler JS, Ricordi C. Stopping type 1 diabetes: attempts to prevent or cure type 1 diabetes in man. Diabetes. 2011 Jan;60(1):1-8. doi: 10.2337/db10-1114. No abstract available.

    PubMed 21193733

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Anti-Thymocyte Globulin (ATG), Interleukin 2 and Exenatide in people with Diabetes Mellitus, Type 1 and Hypoglycemia, run by Camillo Ricordi and Jay Skyler.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Simulated C-peptide AUC (time frame: 1 Year Visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02586831, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.

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