Curing Diabetes

Prevention

STOP-T1D Low-Dose (ATG) (TN28)

The STOP-T1D Low-Dose (ATG) trial is currently recruiting participants aged 12 to under 35 years who are at risk of progressing to Stage 3 type 1 diabetes within two years. This interventional study tests whether low-dose Anti-Thymocyte Globulin (ATG) can delay or prevent the progression to Stage 3 T1D compared to a placebo.

Status: RECRUITING*

Study Type: Interventional

Population: Stage 2 T1D and two year 50% risk of progression to Stage 3 T1D

  • ≥12 years and < 35 years of age
  • ≥ 2 T1D autoantibodies
  • Weight greater than the 5th percentile for age and sex
  • BMI < 95th and > 5th percentile for age for those under age 18 years and < 30 and > 15 for adults (≥ 18)
  • ADA Stage 2 criteria for T1D AND at least one high-risk marker within 7 weeks of randomization (for defining a 2-year 50% risk for progression to Stage 3 T1D)

Intervention: Low dose ATG to delay or prevent progression to Stage 3 T1D

Comparison: Placebo treatment

Outcome: The primary outcome is the elapsed time from random treatment assignment to the development of Stage 3 T1D

Timing:  5 years

Additional information and inclusion criteria: https://clinicaltrials.gov/study/NCT04291703

Contact: Call 305-243-4485 or email cblaschke@miami.edu

Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases

*Status as of April 15, 2024, on https://clinicaltrials.gov .

Keep Up With Our Progress Toward A Cure & More