TArgeting Type 1 Diabetes Using POLyamines (TADPOL)
The goal of this clinical trial is to test a drug known as DFMO in people with Type 1 Diabetes (T1D). The main question\[s\] it aims to answer are: * Does it reduce stress on the cells that make insulin? * Does it preserve what is left of the body's insulin production? Participants will take either DFMO or a placebo (looks like DFMO but has no active ingredients) two times a day for about 6 months. Participants will have 6 in person visits and 1 phone visit over a period of 12 months. Visits will include blood draws urine collection and other tests.
Conditions:
๐Ÿฆ  Type 1 Diabetes
๐Ÿ—“๏ธ Study Start (Actual) 14 March 2023
๐Ÿ—“๏ธ Primary Completion (Estimated) December 2027
โœ… Study Completion (Estimated) December 2027
๐Ÿ‘ฅ Enrollment (Estimated) 70
๐Ÿ”ฌ Study Type INTERVENTIONAL
๐Ÿ“Š Phase PHASE2
Locations:
๐Ÿ“ Aurora, Colorado, United States
๐Ÿ“ Chicago, Illinois, United States
๐Ÿ“ Indianapolis, Indiana, United States
๐Ÿ“ Kansas City, Kansas, United States
๐Ÿ“ Ann Arbor, Michigan, United States
๐Ÿ“ Milwaukee, Wisconsin, United States

๐Ÿ“‹ Eligibility Criteria

Description

    Inclusion Criteria:

    • 1. Males and females 6- โ‰ฅ40 years of age with a clinical diagnosis of T1D
    • 2. T1D clinical diagnosis with insulin start date no more than 100 days prior to the time of randomization
    • 3. Random non-fasting C-peptide level of \>0.2 pmol/mL (equivalent to \>0.6ng/ml) at screening.
    • 4. Positive for any one of the following diabetes-related autoantibodies (IAA, GAA, IA-2, or ZnT8)
    • 5. Treatment naรฏve of any immunomodulatory agent
    • 6. Normal hearing at screening, defined as acceptable results of pure-tone audiometry (\<20 decibel \[dB\] baseline thresholds for frequencies 250, 500, 1000, and 2000 Hz

    Exclusion Criteria:

    • 1. Presence of severe, active disease that interferes with dietary intake or requires the use of chronic medication, with the exception of well-controlled hypothyroidism and mild asthma not requiring oral steroids. Presence of any psychiatric disorder that will affect ability to participate in study.
    • 2. Diabetes other than T1D
    • 3. Chronic illness known to affect glucose metabolism (e.g. Cushing syndrome, polycystic ovarian disorder, cystic fibrosis) or taking medications that affect glucose metabolism (e.g. steroids, metformin)
    • 4. Inability to swallow pills
    • 5. Psychiatric impairment or current use of anti-psychotic medication
    • 6. Any condition that, in the investigator's opinion, may compromise study participation or may confound the interpretation of the study results.
    • 7. Neutropenia (\< 1,500 neutrophils/ฮผL)
    • 8. Leukopenia (\< 3,000 leukocytes /ฮผL)
    • 9. Lymphopenia ( \< 800 lymphocytes/ฮผL)
    • 10. Thrombocytopenia (\<100,000 platelets/ฮผL)
    • 11. Clinically significant anemia or Hemoglobin as defined below:
    • In Adults: Hgb \<12.0g/dL in females and \<13.0g/dL in males In Children: 12- \<18: \<11.4 g/dL in females and \<12.4 g/dL in males In Children: 6- \<12: Hgb \<11.2 g/dL
    • 12. Impaired renal function (assessed by history and BUN/Creatinine, DFMO is renally excreted)
    • 13. Allergy to milk or soy (components of Boostยฎ drink used for mixed meal tolerance testing)
    • 14. Female participants of child-bearing age with reproductive potential, must not be pregnant and agree to use 2 effective forms of birth control or be abstinent during the study period (see below). Male participants (including men who have had vasectomies) whose partners are pregnant or may be pregnant should use condoms while on study drug, until 2 weeks after discontinuation of drug, while the partner is pregnant.
    • 15. Active seizure disorder, defined as requiring chronic medication at the time of study or having had a seizure within the past 12 months at the time of screening
    • 16. Enrollment into another intervention trial.
Ages Eligible for Study: 4 Years to 40 Years (CHILD, ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

๐Ÿ—“๏ธ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 12 October 2022
  • First Submitted that Met QC Criteria 21 October 2022
  • First Posted 26 October 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 30 May 2024
  • Last Update Posted 31 May 2024
  • Last Verified May 2024