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Can a Two-Drug combo help young people with new type 1 diabetes keep making insulin?

NCT ID NCT06455319

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 phase 2 trial tests whether a low dose of anti-thymocyte globulin (ATG), followed by verapamil, can help preserve the body's ability to produce insulin in adolescents and young adults recently diagnosed with type 1 diabetes. The study will enroll 60 people aged 6 to 35 who have had diabetes for less than 100 days. Researchers will use a blood test to predict who will respond best to ATG, and then add verapamil to reduce stress on insulin-making cells.

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) and verapamil
What this could lead to
If successful, this could lead to a treatment that helps people with newly diagnosed type 1 diabetes keep making their own insulin longer, reducing the need for injected insulin.
What could go wrong
This is an early phase 2 trial with only 60 participants, so results may not apply to everyone. The treatment may not work for all, and side effects from ATG or verapamil are possible.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Aug 2030

An estimate. End dates often move.

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

6 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: 1. Must be \>= 6 years \<= 35 2. Must have a diagnosis of T1D for less than 100 days at randomization 3. Willing to provide Informed Consent or have a parent or legal guardian provide informed consent if the subject is \<18 years of age 4. Positive for at least one islet cell autoantibody; GAD65A, mIAA, if obtained within 10 days of the onset of insulin therapy, IA-2A, ICA, or ZnT8A 5. Must have stimulated C-peptide levels of 0.2 pmol/ml measured during a mixed meal tolerance test (MMTT) conducted at least 21 days from diagnosis of diabetes. Randomization should occur within one month (37 days) of the MMTT. 6. Subjects who are EBV seronegative at screening must be EBV PCR negative within 30 days of randomization and may not have had signs or symptoms of an EBV compatible illness lasting longer than 7 days within 30 days of randomization 7. Be at least 6 weeks from last live immunization 8. Participants are required to receive killed influenza vaccination at least 2 weeks prior to randomization when vaccine for the current or upcoming flu season is available 9. Be willing to forgo live vaccines during the treatment period and for 3 months following last dose of study drug 10. Be willing to comply with intensive diabetes management Exclusion Criteria: 1. Be immunodeficient or have clinically significant chronic lymphopenia: (Leukopenia (\< 3,000 leukocytes /μL), neutropenia (\<1,500 neutrophils/μL), lymphopenia (\<800 lymphocytes/μL), or thrombocytopenia (\<100,000 platelets/μL). 2. Have active signs or symptoms of acute infection at the time of randomization 3. Have evidence of prior or current tuberculosis infection as assessed by PPD, interferon gamma release assay or by history 4. Be currently pregnant or lactating, or anticipate getting pregnant within the two year study period 5. Require use of other immunosuppressive agents including chronic use of systemic steroids 6. Have evidence of current or past HIV, Hepatitis B or Hepatitis C infection 7. Have any complicating medical issues or abnormal clinical laboratory results that may interfere with study conduct, or cause increased risk to include pre-existing cardiac disease, COPD, sickle cell disease, neurological, or blood count abnormalities 8. Have a history of malignancies other than skin 9. Evidence of liver dysfunction with AST or ALT greater than 3 times the upper limits of normal 10. Evidence of renal dysfunction with creatinine greater than 1.5 times the upper limit of normal 11. Vaccination with a live virus within the last 6 weeks 12. Current or ongoing use of non-insulin pharmaceuticals that affect glycemic control within prior 7 days of screening 13. Active participation in another T1D treatment study in the previous 30 days 14. Prior treatment with any investigational agent to delay beta cell loss in T1D 15. Known allergy to ATG or Verapamil 16. Prior treatment with ATG, Verapamil or known allergy to rabbit derived products 17. Any condition that in the investigator's opinion may adversely affect study participation or may compromise the study results

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Barbara Davis Center for Diabetes

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Florida

    RECRUITING

    Gainesville, Florida, 32610, United States

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