A Randomized Phase 1/2 Trial of Low Dose Anti-thymocyte Globulin (ATG) With Subsequent Adalimumab or Verapamil in New Onset Type 1 Diabetes
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 9 Years to 20 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests low-dose anti-thymocyte globulin (ATG), followed by adalimumab or verapamil, in people ages 9 to 20 with newly diagnosed type 1 diabetes. It checks safety and whether these drugs help the body keep making insulin over 2 years.
This multi-center randomized controlled trial will assess the safety and efficacy of ATG followed by either adalimumab or verapamil in preserving insulin secretion 2 years from randomization in persons aged 9 to \<21 with recent-onset stage 3 T1D.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be ages 9 to 20, with stage 3 type 1 diabetes. You must be assigned to a study group within 6 months of diagnosis and within 37 days of screening.
- Have at least one positive test for a type 1 diabetes antibody, a sign that the immune system attacks insulin-making cells.
- Still make some insulin: have a C-peptide level of at least 0.2 pmol/mL during a mixed-meal test.
- Weigh more than 30 kg (about 66 pounds). Have a BMI, a measure of weight compared with height, below the 95th percentile for your age and sex.
- Agree to close diabetes care. Stop non-insulin blood sugar medicines at least 30 days before screening and avoid them during study treatment.
- Follow pregnancy prevention rules. If you can become pregnant, you must not be pregnant, must avoid pregnancy and breastfeeding, and must take pregnancy tests. If you can father children, follow condom or no-sex rules and avoid sperm donation during treatment and for 90 days afterward.
- Be able to understand and agree to the study, with a child's agreement when needed. You and your legal representative, if needed, must read and understand English or Spanish. Allow your diabetes doctor to be notified.
- Be fully vaccinated for your age, including a flu vaccine if it is flu season. Avoid live vaccines during treatment.
Who can't join
- Past ATG treatment or an allergy to ATG, rabbit products, study drugs, or required tape. Serious milk or soy allergy, or being unable to swallow pills, also rules you out.
- Certain abnormal blood counts, including too few infection-fighting cells, too few platelets that help blood clot, low hemoglobin, or too many white blood cells.
- Current or certain past serious infections, including tuberculosis, HIV, hepatitis B, or current hepatitis C. Recent illness or positive tests for CMV or EBV viruses, or a positive COVID-19 test within 3 days of group assignment, may also rule you out.
- Certain heart diseases, abnormal heart rhythms or heart tests, very low blood pressure or pulse, or past fainting linked to low blood pressure.
- Past cancer other than skin cancer, or another condition that could make the study unsafe. Examples include certain liver, kidney, immune system, nerve, mental health, or bowel problems, or alcohol or drug abuse.
- Past or current use of teplizumab, adalimumab, verapamil, or certain medicines that change the immune system. Other medicines that affect blood sugar or study results may also rule you out.
- Needing certain medicines during the study, including some blood pressure, seizure, or cholesterol medicines; lithium; theophylline; clonidine; or hydroxyurea.
- A live vaccine within 90 days before group assignment, or another treatment study involving diabetes care or the immune system, unless you received only placebo (no active drug).
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Key Inclusion Criteria: 1. Recent-onset stage 3 T1D diagnosed by standard ADA criteria, with the ability to be randomized within 6 months from the date of T1D diagnosis and within 37 days of Screening Visit. 2. At least one positive T1D auto-antibody. * If clearly positive (≥20% above local lab's ULN) at screening, repeat antibody testing for central lab is not required. * Insulin auto-antibodies are only considered if exogenous insulin use is \<10 days when blood is drawn. 3. Must have stimulated C-peptide levels ≥0.2 pmol/mL (≥0.6 ng/mL) measured during MMTT conducted prior to randomization. 4. Age 9 to \<21 years at the time of randomization. 5. Body weight \>30kg. 6. BMI \<95th percentile for age and gender. 7. Willing to comply with intensive diabetes management. 8. Female participants with childbearing potential are not currently pregnant, are willing to avoid pregnancy and breastfeeding, and to undergo pregnancy testing prior to MMTTs for the duration of the study. a. Women of childbearing potential (WOCBP) must use an acceptable form of birth control. Acceptable forms include oral/injection contraceptives, transdermal contraceptives, diaphragm, intrauterine devices, condoms with spermicide, documented surgical sterilization of either the participant or their partner or abstinence. 9. Male participants with potential to father children must be willing to use abstinence or adequate contraceptive methods for the duration of the study. a. Males must agree to be sexually abstinent or use a condom and agree not to donate sperm for the treatment period and for a minimum of 1 spermatogenesis cycle (90 days after last dose of study drug) after last treatment. 10. Willing to provide informed consent and child assent as applicable. 11. Willing to provide their primary endocrinologist's contact information and have their primary endocrinologist notified of their participation 12. Sufficient cognitive ability, per investigator judgment, to provide informed consent for study participation on an IRB approved consent form. 13. Able to read and understand English or Spanish (both participant and legally authorized representative, if applicable). 14. Must be fully vaccinated for age. 15. Must have been vaccinated for flu (if currently in flu season). 16. Must be willing to not receive live vaccines throughout the treatment period. 17. Must be willing to not use any non-insulin glucose-lowering agents such as GLP-1 agonists (including for weight loss indication), symlin, DPP-4 inhibitors, SGLT-2 inhibitors, biguanides, sulfonylureas) for the duration of study treatment. Participants are required to go off these drugs at least 30 days prior to screening. Key Exclusion Criteria: 1. Prior treatment with ATG or known allergy to ATG or rabbit-derived products. 2. Local lab draw at screening: 1. Immunodeficient or have clinically significant chronic lymphopenia: Leukopenia (\<3,000 leukocytes /μL), neutropenia (\<1,500 neutrophils/μL), lymphopenia (\<800 lymphocytes/μL). 2. Thrombocytopenia (\<100,000 platelets/μL) or anemia (hemoglobin \< 10g/dL). 3. Leukocytosis (\>14,000/μL) 3. Infections: 1. Ongoing infection or had recently had a major infection requiring hospitalization or intravenous antibiotics.within 30 days prior to randomization. 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 interferon gamma release assay (QuantiFERON-TB Gold), or a positive test for latent tuberculosis. 4. Have evidence of current or past HIV or Hepatitis B or current Hepatitis C infection. 5. History of serious bacterial, viral, fungal, or other opportunistic infections. 4. Have active signs or symptoms of CMV or EBV compatible illness lasting more than 7 days within 30 days of randomization. 5. Have positive CMV and/or EBV PCR test within 30 days prior to randomization. 6. Have positive COVID-19 self-antigen test within 3 days of randomization. 7. History of underlying cardiac disease (ex. left ventricular dysfunction, hypertrophic cardiomyopathy), certain arrhythmias (e.g. AV block, accessory pathway such as Wolff- Parkinson-White or Lown-Ganong-Levine syndromes) or abnormal ECG (unless cleared by cardiology). 8. Blood pressure (either systolic or diastolic) \<5th percentile for age, gender, and height on two out of three measurements. 9. Pulse \<2.5th percentile for age and gender on two out of three measurements. 10. History of vasovagal syncopal episodes related to hypotension. 11. History of malignancies other than of skin. 12. Use of medications likely to interfere with study results: 1. Any immunomodulators, including systemic steroids or participation in prior research study in which a potential participant received an immunomodulatory agent (may participate if received placebo only). 2. Current or previous use of Teplizumab, Adalimumab, or Verapamil. 3. Ongoing use of medications known to influence glycemia or glucose tolerance. Only topical steroids are allowed. 13. Need to use of any of the following medications during the study: beta blocker, seizure medication (carbamazepine, phenobarbital, phenytoin), other antihypertensive medications, HMG-CoA reductase inhibitors, lithium, theophylline, clonidine. 14. Receipt of live vaccine (e.g., varicella, measles, mumps, rubella, cold-attenuated intranasal influenza vaccine, bacillus Calmette-Guerin, and smallpox) within the 90 days before randomization. 15. Any known hypersensitivity reaction to any of the study medications or their components. 16. Unable to swallow pills (tested with an inert imitation tablet in clinic at screening). 17. History of significant allergy (e.g., anaphylaxis) to milk or soy proteins in the Boost drink required for study MMTT testing. 18. Current use of hydroxyurea or unable to avoid hydroxyurea use during the study (interferes with accuracy of Dexcom sensor). 19. Established history of allergy or severe reaction to adhesive or tape that must be used in the study. 20. Participation in another treatment research study that involves diabetes care or immune modulation, unless the participant is able to confirm that they were in the placebo arm. 21. Presence of a medical condition or use of a medication that, in the judgment of the investigator, clinical protocol chair, or medical monitor, could compromise the results of the study or the safety of the participant. Conditions to be considered by the investigator may include the following: 1. Alcohol or drug abuse 2. Untreated or inadequately treated mental illness 3. Liver disease or LFTs \>2x ULN. 4. Renal disease or creatinine greater than 1.5x ULN. 5. Other autoimmune diseases except for stable and treated hypothyroidism Graves' disease, or celiac disease (e.g., symptom-free on a gluten free diet). 6. Nervous system disorder including but not limited to Guillain-Barre Syndrome, multiple sclerosis, progressive multifocal leukoencephalopathy. 7. History of multiple abdominal surgeries and/or at increased risk for bowel obstruction. 22. Any clinical or laboratory conditions that the investigator feels would interfere with the study or participant safety (e.g., increased risk to pre-existing disease). Any lab abnormality believed to be transient may be repeated at the discretion of the site PI. If repeat value does not preclude participation, and potential participant would otherwise qualify for the study, then may proceed with enrollment per investigator discretion. \-
Study sites (11)
CA
- UCLA · Los Angeles, CA 90095Angela Martinez · Study contact · 3108250867 · angelamartinez@mednet.ucla.eduChristina Reh, MD · Principal investigatorMore trials in Los Angeles
- UCSF · San Francisco, CA 94143Rebecca Wesch · Study contact · 415-476-5984 · rebecca.wesch@ucsf.eduStephen Gitelman, MD · Principal investigatorMore trials in San Francisco
CT
- Yale University · New Haven, CT 06511Amy Steffen · Study contact · 203-737-8852 · amy.steffen@yale.eduLaura Nally, MD · Principal investigatorMore trials in New Haven
FL
- University of Florida · Gainesville, FL 32610Danielle J. Poulton · Study contact · 352-294-5760 · danielle.poulton@peds.ufl.eduLaura Jacobsen, MD · Principal investigatorMore trials in Gainesville
- University of Miami · Miami, FL 33136Danay Saavedra · Study contact · 305-243-7740 · dxs4415@med.miami.eduDavid Baidal · Principal investigatorMore trials in Miami
IN
- Indiana University · Indianapolis, IN 46202Hannah Lease · Study contact · 317-278-4874 · hlease@iu.eduLinda DiMeglio, MD, MPH · Principal investigatorMore trials in Indianapolis
MN
- University of Minnesota · Minneapolis, MN 55455Shannon Beasley · Study contact · 612-625-5609 · beasl103@umn.eduAntoinette Moran, MD · Principal investigatorMore trials in Minneapolis
NY
- University of Buffalo · Buffalo, NY 14203Amanda House · Study contact · 716-323-0075 · ahouse@upa.chob.eduTeresa Quattrin, MD · Principal investigatorMore trials in Buffalo
PA
- University of Pittsburgh · Pittsburgh, PA 15224Kelli DeLallo · Study contact · 412-692-5210 · elli.delallo@chp.eduIngrid Libman, MD · Principal investigatorMore trials in Pittsburgh
TX
- Baylor College of Medicine · Houston, TX 77030Marion J Valladares · Study contact · 832-824-9316 · Marion.Valladares@bcm.eduRebecca Aguirre, MD, PhD · Principal investigatorMore trials in Houston
WA
- Seattle Children's Hospital · Seattle, WA 98105Kevin Bocek · Study contact · 206-643-5599 · Kevin.Bocek@seattlechildrens.orgPetter Bjornstad, MD · Principal investigatorMore trials in Seattle