DFMO for Type 1 Diabetes
(TADPOL Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking medications that affect glucose metabolism, like steroids or metformin. It's best to discuss your current medications with the trial team.
How is the drug DFMO unique for treating type 1 diabetes?
DFMO (also known as Eflornithine) is unique because it is being explored as a potential treatment for type 1 diabetes, a condition that primarily relies on insulin therapy. Unlike traditional treatments, DFMO may offer a novel approach by targeting different pathways, although its exact mechanism in type 1 diabetes is still under investigation.12345
What is the purpose of this trial?
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.
Research Team
Emily K Sims, MD,MS
Principal Investigator
Indiana University School of Medicine
Eligibility Criteria
The TADPOL trial is for people aged 6-40 with recent Type 1 Diabetes diagnosis, who still produce some insulin and have not used immunomodulatory drugs. They must have normal hearing, no psychiatric disorders affecting participation, and agree to use birth control if applicable. Excluded are those with conditions or medications influencing glucose metabolism, active seizure disorders, difficulty swallowing pills, certain blood or kidney issues.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Run-in
Eligibility is determined and glycemic control is optimized
Treatment
Participants receive either DFMO or placebo for 6 months
Wash-out
A 6-month period to assess the durability of the treatment effect
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- DFMO
- Placebo
DFMO is already approved in United States, European Union for the following indications:
- Sleeping sickness (African trypanosomiasis)
- Hirsutism
- Sleeping sickness (African trypanosomiasis)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Emily K. Sims
Lead Sponsor
Juvenile Diabetes Research Foundation
Collaborator
Cancer Prevention Pharmaceuticals, Inc.
Industry Sponsor