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Immunosuppressant

ATG + Verapamil for Type 1 Diabetes

Phase 2
Waitlist Available
Led By Laura M Jacobsen, MD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age must be between 6 and 35 years
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
Must not have
Have a history of malignancies other than skin
Evidence of liver dysfunction with AST or ALT greater than 3 times the upper limits of normal
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6, 12, 18, 24 months

Summary

"This trial is testing a combination of two treatments, anti-thymocyte globulin (ATG) and verapamil, in individuals with recently diagnosed type 1 diabetes. ATG has been shown

Who is the study for?
This trial is for individuals recently diagnosed with type 1 diabetes. It aims to find out if low doses of ATG can help control blood sugar and preserve insulin production. Participants should likely respond to ATG, as determined by a specific biomarker test.
What is being tested?
The study tests the effectiveness of anti-thymocyte globulin (ATG) alone or followed by verapamil in preserving insulin production in type 1 diabetes patients. It also explores whether combining these treatments has synergistic effects.
What are the potential side effects?
Possible side effects include reactions related to immune system suppression from ATG, such as increased infection risk, and typical calcium channel blocker side effects from verapamil like low blood pressure, dizziness, or heart issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 6 and 35 years old.
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My C-peptide levels were measured and confirmed during a specific test after my diabetes diagnosis.
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I have not had symptoms of an Epstein-Barr virus infection lasting more than a week recently.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had cancer other than skin cancer.
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My liver tests are more than three times the normal range.
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I have a weakened immune system or chronic low blood cell counts.
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I currently have symptoms of an infection.
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I have tried experimental treatments for Type 1 Diabetes.
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I have had tuberculosis in the past or currently, confirmed by a test or medical history.
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I need to take immunosuppressive drugs or steroids regularly.
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My kidney function is impaired, with creatinine levels above normal.
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I have used diabetes medication other than insulin in the last week.
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I have not been treated with ATG or Verapamil and have no allergies to rabbit products.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6, 12, 18, 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6, 12, 18, 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
AUC C-peptide between ATG and placebo values
Change in 2-hr MMTT AUC C-peptide
Secondary study objectives
Immune and beta cell mechanistic analyses

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: verapamil extended release capsuleExperimental Treatment1 Intervention
Open label administration at 120, 240 or 360 mg daily based on weight and ECG findings
Group II: Anti-thymocyte globulin (ATG) intravenous infusionExperimental Treatment1 Intervention
ATG (brand name Thymoglobulin) a polyclonal T cell antibody preparation. It will be given at low doses (0.5 mg/kg Day 1 then 2 mg/kg Day 2).
Group III: Placebo-ATGPlacebo Group1 Intervention
Saline placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Anti-thymocyte globulin (ATG)
2018
Completed Phase 2
~350

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor
1,409 Previous Clinical Trials
767,163 Total Patients Enrolled
University of Colorado, DenverOTHER
1,810 Previous Clinical Trials
2,920,040 Total Patients Enrolled
University of MiamiOTHER
955 Previous Clinical Trials
428,793 Total Patients Enrolled
Laura M Jacobsen, MDPrincipal InvestigatorUniversity of Florida
~40 spots leftby Apr 2028
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