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New treatment option for Type 1 Diabetes
Official title Precision Administration of Anti-thymocyte Globulin With or Without Verapamil
ClinicalTrials.gov ID: NCT06455319
What this study is testing
What is Anti-thymocyte globulin (ATG)?
Anti-thymocyte globulin (ATG) is an investigational medicine, being studied as a potential treatment for type 1 diabetes.
Also referred to as Thymoglobulin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- T cell directed therapy, anti-thymocyte globulin (ATG), in low doses, has been shown to lower HbA1c and preserve endogenous insulin production (measured by C-peptide) in individuals with recently diagnosed type 1 diabetes (T1D). However, not all individuals who received ATG responded to the therapy (i.e., non-responders).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 35
You may be able to join if
- Must be \>= 6 years \<= 35
- Must have a diagnosis of T1D for less than 100 days at randomization
- Willing to provide Informed Consent or have a parent or legal guardian provide informed consent if the subject is \<18 years of age
- 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
- 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...
You likely can't join if
- Be immunodeficient or have clinically significant chronic lymphopenia: (Leukopenia (\< 3,000 leukocytes /μL), neutropenia (\<1,500 neutrophils/μL)...
- Have active signs or symptoms of acute infection at the time of randomization
- Have evidence of prior or current tuberculosis infection as assessed by PPD, interferon gamma release assay or by history
- Be currently pregnant or lactating, or anticipate getting pregnant within the two year study period
- Require use of other immunosuppressive agents including chronic use of systemic steroids
- Have evidence of current or past HIV, Hepatitis B or Hepatitis C infection
See the full eligibility criteria
- Must be \>= 6 years \<= 35
- Must have a diagnosis of T1D for less than 100 days at randomization
- Willing to provide Informed Consent or have a parent or legal guardian provide informed consent if the subject is \<18 years of age
- 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
- 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...
- people 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...
- Be at least 6 weeks from last live immunization
- 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
- Be willing to forgo live vaccines during the treatment period and for 3 months following last dose of study drug
- Be willing to comply with intensive diabetes management
- 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...
- Have active signs or symptoms of acute infection at the time of randomization
- Have evidence of prior or current tuberculosis infection as assessed by PPD, interferon gamma release assay or by history
- Be currently pregnant or lactating, or anticipate getting pregnant within the two year study period
- Require use of other immunosuppressive agents including chronic use of systemic steroids
- Have evidence of current or past HIV, Hepatitis B or Hepatitis C infection
- 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...
- 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
- Evidence of renal dysfunction with creatinine greater than 1.5 times the upper limit of normal
- Vaccination with a live virus within the last 6 weeks
- Current or ongoing use of non-insulin pharmaceuticals that affect glycemic control within prior 7 days of screening
- Active participation in another T1D treatment study in the previous 30 days
- Prior treatment with any investigational agent to delay beta cell loss in T1D
- Known allergy to ATG or Verapamil
- Prior treatment with ATG, Verapamil or known allergy to rabbit derived products
- Any condition that in the investigator's opinion may adversely affect study participation or may compromise the study results
The study team makes the final eligibility decision.
Where it's taking place
- Aurora, Colorado, United States
- Gainesville, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 35 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aurora, Colorado, United States; Gainesville, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.