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Targeting Polyamines using DFMO in Persons with Type 1 Diabetes: A Randomized Double-Masked Placebo-Controlled Phase I/II Study to Evaluate the Safety Tolerability and Initial Pharmacodynamics of Multiple Ascending Doses

Investigating the Effects of an Investigational Medication on Beta Cell Stress in Type 1 Diabetes

Recruiting
12-40 years
All
Phase N/A

This study investigates how different doses of an investigational medication, referred to as DFMO, affect the stress levels of beta cells in the body. Beta cells are responsible for producing insulin, and the study aims to see if the medication can help preserve something called c-peptide, which is a part of insulin production.

Participants in this study will undergo various procedures to monitor the effects of the investigational medication. These procedures may include blood tests and other assessments to measure the stress on beta cells and the levels of c-peptide.

  • Who can participate: Individuals diagnosed with type 1 diabetes within the past 2 to 8 months and who have normal hearing are eligible to participate. Participants should not have any severe active diseases affecting diet or requiring chronic medication, except for well-controlled hypothyroidism and mild asthma.
  • Study details: Participants will be required to take the investigational medication in pill form, and their health will be monitored through various tests. The study may include a placebo, which is an inactive substance that looks like the investigational medication but does not contain any medicine.
Study details
    type 1 diabetes
    type i diabetes
    diabetes
    diabetic

TX4823

19 February 2024

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Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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