TArgeting Type 1 Diabetes Using POLyamines (TADPOL): A Randomized, Double-Masked, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy and Safety of Difluoromethylornithine (DFMO) to Preserve Insulin Production in Type 1 Diabetes
Primary Objective
• Examine the clinical efficacy of 1000 mg/m2 /day of oral DFMO to stabilize or improve loss of β cell function in persons with recent onset T1D. Our primary endpoint defining clinical efficacy will be based on mixed-meal stimulated C-peptide AUC in the treatment group compared to placebo after 6 months of DFMO treatment. • Examine the safety and tolerability of 1000 mg/m2 /day of oral DFMO in persons with new onset T1D. Adverse event assessments, complete blood counts (CBC), comprehensive metabolic profiles (CMP), and audiology testing will be performed to assess tolerability of treatment in this larger group of participants.
Description
This study will be a multicenter, double-blind, placebo-controlled, 2:1 random assigned, phase II clinical trial for individuals with recent onset type 1 diabetes. We are conducting 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 of screening and a run-in period during which eligibility will be determined and glycemic control optimized, 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. Subjects will be randomly assigned either 1000mg/m2/day oral DFMO or placebo treatment at a 2:1 ratio.
Details
Locations
Barbara Davis Center
University of Colorado Hospital
Principal Investigator
Kimber Simmons
Study ID
Protocol Number: 23-0398
More information available at ClinicalTrials.gov: NCT05594563
Categories
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