TArgeting Type 1 Diabetes Using POLyamines (TADPOL) (TADPOL)
E
Emily Sims, MD
Primary Investigator
Enrolling By Invitation
6 years - 40 years
All
Phase
2
70 participants needed
3 Locations
Brief description of study
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 takeher DFMO or a placebo (looks like DFMO but has no active ingredients) two times a daybout 6 months. Participants will have 6 in person visits and 1 phone visit over ad of 12 months. Visits will include blood draws urine collection and other tests.
Detailed description of study
This study will be a multicenter, double-blind, placebo-controlled, 2:1 random assigned,hase II clinical trial for individuals with recent onset type 1 diabetes. The investigatorsducting a double masked placebo-controlled intention to treat study enrolling persons
with new onset T1D with documented continued residual C-peptide production. Within 45 days ofg and a run-in period during which eligibility will be determined and glycemiczed, subjects will have a 6-month double-masked treatment period with either
DFMO or placebo. After a 6-month wash-out period the durability of effect will be assessed.ubjects will be randomly assigned either 1000mg/m2/day oral DFMO or placebo treatment at a
2:1 ratio.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Type 1 Diabetes, Riley
-
Age: 6 years - 40 years
-
Gender: All
Inclusion Criteria:
- Males and females 6- ≥40 years of age with a clinical diagnosis of T1D
- T1D clinical diagnosis with insulin start date no more than 100 days prior to the timedomization
- Random non-fasting C-peptide level of >0.2 pmol/mL (equivalent to >0.6ng/ml) atg.
- Positive for any one of the following diabetes-related autoantibodies (IAA, GAA, IA-2,ZnT8)
- Treatment naïve of any immunomodulatory agent
- 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:
- Presence of severe, active disease that interferes with dietary intake or requires theuse of chronic medication, with the exception of well-controlled hypothyroidism andd asthma not requiring oral steroids. Presence of any psychiatric disorder thatwill affect ability to participate in study.
- Diabetes other than T1D
- Chronic illness known to affect glucose metabolism (e.g. Cushing syndrome, polycysticvarian disorder, cystic fibrosis) or taking medications that affect glucosebolism (e.g. steroids, metformin)
- Inability to swallow pills
- Psychiatric impairment or current use of anti-psychotic medication
- Any condition that, in the investigator's opinion, may compromise study participationy confound the interpretation of the study results.
- Hematologic abnormalities at screening (anemia, leukopenia (particularly neutropenia),hrombocytopenia)
- Impaired renal function (assessed by history and BUN/Creatinine, DFMO is renallyd)
- Allergy to milk or soy (components of Boost® drink used for mixed meal toleranceg)
- Female participants of child-bearing age with reproductive potential, must not begnant and agree to use 2 effective forms of birth control or be abstinent duringhe study period (see below)
- Active seizure disorder, defined as requiring chronic medication at the time of studyhaving had a seizure within the past 12 months at the time of screening
Updated on
14 Sep 2024.
Study ID: 4-SRA-2022-1205-M-B, PENDO-IIR-TADPOL, 16697
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