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Withdrawn before start: experimental cocktail for type 1 diabetes never tested

NCT ID NCT02586831

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study aimed to test whether a combination of four drugs—ATG, low-dose IL-2, adalimumab, and exenatide—could help people newly diagnosed with type 1 diabetes keep producing their own insulin. The trial planned to enroll adults aged 18-35 diagnosed within the last 120 days. However, the study was withdrawn before any participants were enrolled, so no data is available.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Anti-Thymocyte Globulin (ATG), low-dose Interleukin-2 (IL-2), adalimumab, and exenatide
What this could lead to
If successful, this combination could help people with new-onset type 1 diabetes keep making their own insulin longer, reducing the need for injected insulin.
What could go wrong
This trial was withdrawn before enrolling anyone, so no results are available. The combination of multiple immune-suppressing drugs carries risks of infection and other side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Expected to start

Jun 2024

An estimate. Start dates often move.

Finished

Jun 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 35 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients must meet all of the following criteria to be eligible to participate in this study: 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: * Potential participants must not meet any of the following 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

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