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 years - 40 years
All
Phase N/A
1 Location

Brief description of study.

The purpose of this study is to determine if different doses of a drug known as DFMO have an effect on reducing the amount of stress that is experienced by the body's beta cells and preserves residual c-peptide.

Detailed description of study

The purpose of this study is to determine if different doses of a drug known as DFMO have an effect on reducing the amount of stress that is experienced by the body's beta cells and preserves residual c-peptide.

Participants will be paid for their participation.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: type 1 diabetes,type i diabetes,diabetes,diabetic
  • Age: 12 years - 40 years
  • Gender: All

Inclusion Criteria
Clinical diagnosis of type 1 diabetes within 2-8 months
Normal hearing
Exclusion Criteria
Presence of severe, active disease that interferes with dietary intake or requires the use of chronic medication, with exception of well-controlled hypothyroidism and mild asthma not requiring oral steroids
Diabetes other than T1D
Chronic illness known to affect glucose metabolism
Inability to swallow pills
Psychiatric impairment or current use of anti-psychotic medication
Hematologic abnormalities
Impaired renal function
Pregnant

Updated on 19 Feb 2024. Study ID: 1411735324

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.

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