Actively Recruiting
A Randomized Phase 1/2 Trial of Low Dose Anti-thymocyte Globulin (ATG) With Subsequent Adalimumab or Verapamil in New Onset Type 1 Diabetes
Led by City of Hope Medical Center · Updated on 2026-06-02
120
Participants Needed
11
Research Sites
52 weeks
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
J
Jaeb Center for Health Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of low dose Anti-thymocyte Globulin (ATG) followed by either adalimumab or verapamil in people aged 9 to under 21 years who have recently been diagnosed with stage 3 type 1 diabetes (T1D). This study aims to preserve insulin secretion over two years from randomization and includes assessments of metabolic and safety outcomes at various points during this period. The trial is randomized and controlled, involving multiple centers, and focuses on new onset T1D. Participants receive low dose ATG given intravenously over two days. After this, they are assigned to one of three groups: ATG with placebo, ATG with verapamil capsules taken daily at doses based on weight and heart monitoring from week 6 to week 156, or ATG with adalimumab injections given every other week from week 6 to week 156. The study uses triple masking to keep participants and researchers unaware of group assignments. During the trial, participants will undergo various assessments including mixed-meal tolerance tests to measure stimulated C-peptide levels, monitoring for adverse events, blood counts, and heart evaluations. Researchers will track insulin secretion at 104 weeks as the primary outcome and observe safety measures such as severe hypoglycemia and diabetic ketoacidosis. The study duration from start to the last visit spans approximately three years, with regular visits scheduled for ongoing assessments and safety monitoring.
CONDITIONS
Brief Title
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 Participate
Eligibility Criteria
You may qualify if you...
- Recent-onset stage 3 type 1 diabetes diagnosed by standard ADA criteria
- Randomization within 6 months from diagnosis and within 37 days of screening
- At least one positive type 1 diabetes auto-antibody
- Stimulated C-peptide levels ≥0.2 pmol/mL before randomization
- Age 9 to under 21 years at randomization
- Body weight greater than 30 kg
- BMI less than 95th percentile for age and gender
- Willing to comply with intensive diabetes management
- Female participants not pregnant, willing to avoid pregnancy and breastfeeding, and agree to pregnancy testing
- Women of childbearing potential must use acceptable birth control methods
- Male participants with reproductive potential must agree to contraceptive methods or abstinence
- Able to provide informed consent and assent as applicable
- Able to read and understand English or Spanish
- Fully vaccinated for age and flu vaccinated if in flu season
- Willing to avoid live vaccines and non-insulin glucose-lowering agents during the study
You will not qualify if you...
- Prior treatment with ATG or allergy to ATG or rabbit-derived products
- Immunodeficient or significant blood cell count abnormalities
- Ongoing or recent serious infections, including tuberculosis, HIV, hepatitis B or C, CMV, EBV, or COVID-19
- History of serious bacterial, viral, fungal, or opportunistic infections
- Certain heart conditions or abnormal ECG unless cleared by cardiology
- Low blood pressure or pulse below age and gender percentiles
- History of vasovagal syncope related to low blood pressure
- History of malignancies except skin cancer
- Use of immunomodulators, certain medications, or live vaccines within 90 days prior to randomization
- Known hypersensitivity to study medications or components
- Unable to swallow pills
- Allergy to milk or soy proteins in test drinks
- Use of hydroxyurea or allergy to adhesives used in the study
- Participation in other diabetes or immune modulation studies unless in placebo arm
- Medical or laboratory conditions that may affect study safety or results, including liver, kidney, autoimmune, or nervous system disorders
- Substance abuse or untreated mental illness
- History of multiple abdominal surgeries or high risk of bowel obstruction
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 37 days before randomization
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Up to 156 weeks from randomization
Participants receive low dose Anti-thymocyte globulin (ATG) infused over 2 days. Starting 6 weeks after ATG, participants receive either adalimumab injections every other week or daily oral verapamil based on their group assignment.
ATG infusion on Days 0 and 1; adalimumab injections every other week from Week 6 to Week 156 or daily oral verapamil from Week 6 to Week 156
Duration - Up to 2 years after randomization
Participants are monitored for safety and metabolic outcomes during and after treatment up to 2 years.
Multiple visits including assessments at Weeks 13, 26, 52, 78, 104, and 156
Trial Site Locations
Total: 11 locations
1
UCSF
San Francisco, California, United States, 94143
Actively Recruiting
2
Barbara Davis Center for Diabetes University of Colorado Anschutz
Aurora, Colorado, United States, 80045
Not Yet Recruiting
3
Yale University
New Haven, Connecticut, United States, 06511
Not Yet Recruiting
4
University of Florida
Gainesville, Florida, United States, 32610
Actively Recruiting
5
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
6
Indiana University
Indianapolis, Indiana, United States, 46202
Actively Recruiting
7
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
8
University of Buffalo
Buffalo, New York, United States, 14203
Actively Recruiting
9
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
10
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
11
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Actively Recruiting
Research Team
R
Robert Henderson, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here