StudyFinder
A Randomized Phase 1/2 Trial of Low Dose Anti-thymocyte Globulin (ATG) With subsequent Adalimumab or Verapamil in New Onset Type 1 Diabetes
Status: Recruiting
This study is looking at if we give ATG followed by either adalimumab or verapamil if those combinations will help in preserving insulin secretion 2 years after newly diagnosed type 1 diabetes.
Sex: Male or Female
Age Group: Not specified
Inclusion Criteria:
• age 9 to <21 years
• recently diagnosed with T1D and can start the treatment phase within 6 months of diagnosis
• body weight more than 66 pounds
• fully vaccinated for age and willing to avoid certain live vaccines during the study
• able to read and understand English or Spanish
• use only insulin to control blood sugar (no other glucose-lowering medicines)
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:
• history of serious bacterial, viral, fungal, or other infections or current active infection
• history of underlying heart disease
• history of cancer other than of skin
• severe allergy to milk or adhesives
• see link to clinicaltrials.gov for complete Exclusion criteria
Interventions:
Drug: Adalimumab, Drug: Anti-thymocyte globulin (ATG), Drug: verapamil extended-release capsule
Conditions:
Diabetes & Endocrine
Keywords:
T1D, Type 1 Diabetes
Study Contact: Veronica Jones-Carr - jone2678@umn.edu
Principal Investigator: Antoinette Moran
Phase: PHASE1
IRB Number: STUDY00025666
See this study on ClinicalTrials.gov