← Back to Search

Polyamine Synthesis Inhibitor

DFMO for Type 1 Diabetes (TADPOL Trial)

Phase 2
Recruiting
Research Sponsored by Emily K. Sims
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Males and females 6- ≥40 years of age with a clinical diagnosis of T1D
Treatment naïve of any immunomodulatory agent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of one year
Awards & highlights

TADPOL Trial Summary

This trial tests if a drug, DFMO, helps reduce stress on cells that make insulin and preserves insulin production in people with Type 1 Diabetes. Participants take DFMO/placebo 2x/day for 6 months & have 6 in-person & 1 phone visit over 12 months.

Who is the study for?
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.Check my eligibility
What is being tested?
This study tests DFMO's ability to reduce stress on insulin-producing cells and preserve insulin production in Type 1 Diabetes patients over a period of about six months. Participants will be randomly assigned to take either DFMO or a placebo twice daily and will undergo various tests including blood draws during their visits.See study design
What are the potential side effects?
While the specific side effects of DFMO are not listed here, common drug-related side effects could include digestive discomforts like nausea or diarrhea; allergic reactions; fatigue; headaches; potential impacts on liver function which would be monitored through blood tests.

TADPOL Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 6 and 40 years old and have been diagnosed with Type 1 Diabetes.
Select...
I have not received any immune system modifying treatments.
Select...
I have tested positive for a diabetes-related autoantibody.

TADPOL Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of one year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of one year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinical efficacy of 1000 mg/m2/day of oral DFMO after 6 months of treatment
Therapeutic procedure
Secondary outcome measures
Therapeutic procedure
Clinical efficacy of 1000 mg/m2/day of oral DFMO after 3 months of treatment, 9 months after treatment (or 3 months after treatment end), and 12 months after treatment (or 6 months after treatment end).
Decrease in urinary polyamides after 6 months of DFMO treatment.

TADPOL Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Treatment ArmActive Control1 Intervention
Difluoromethylornithine (DFMO) pill ,1000mg/m2/day, for 6 months
Group II: Placebo ArmPlacebo Group1 Intervention
Placebo pill taken twice a day orally for 6 months

Find a Location

Who is running the clinical trial?

Emily K. SimsLead Sponsor
Juvenile Diabetes Research FoundationOTHER
232 Previous Clinical Trials
141,714 Total Patients Enrolled
Cancer Prevention Pharmaceuticals, Inc.Industry Sponsor
7 Previous Clinical Trials
1,712 Total Patients Enrolled

Media Library

DFMO (Polyamine Synthesis Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05594563 — Phase 2
Type 1 Diabetes Research Study Groups: Treatment Arm, Placebo Arm
Type 1 Diabetes Clinical Trial 2023: DFMO Highlights & Side Effects. Trial Name: NCT05594563 — Phase 2
DFMO (Polyamine Synthesis Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05594563 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research require enrollees to be older than 35 years old?

"The criteria for eligibility necessitates that those partaking in this study are aged between 6 and 40. Additionally, there are 219 medical trials available to minors, and 921 clinical trials catered towards senior citizens."

Answered by AI

How many venues is this research project taking place within?

"Currently, 6 medical centres are running this trial. They include Kansas City, Indianapolis and Ann Arbor among others. To minimise travel time in the event of your enrolment, it is advised that you select the clinic closest to you."

Answered by AI

What criteria must a person satisfy to be eligible for participation in this clinical trial?

"For admission into this clinical trial, prospective patients should have type 1 diabetes mellitus and be between the ages of 6 - 40. This study is currently looking to recruit around 70 qualified candidates."

Answered by AI

What can be expected from the safety profile of Treatment Arm?

"There is some evidence to suggest that Treatment Arm can be considered safe, so it recieved a rating of 2 on the scale. This is due to this being a Phase 2 trial which has data suggesting safety but no information regarding efficacy."

Answered by AI

Are there any available vacancies in this trial open to participants?

"The clinicaltrials.gov registry reveals that although this trial was first listed on December 1, 2022 and last modified on October 21, 2022, it no longer searches for participants. Fortunately, there are still 1258 other medical studies actively looking to enrol subjects at this time."

Answered by AI
~47 spots leftby Dec 2027