The randomised, double-blind study is conducted in partnership with the Indiana University School of Medicine and funded by global type 1 diabetes research and advocacy organisation JDRF.
Up to 70 participants with recent onset type 1 diabetes are anticipated to be enrolled at six US centres.
In the trial, participants will be randomised in a 2:1 ratio to receive a 1000mg/m² CPP-1X-T dose orally twice a day with food, or a placebo, for more than six months.
This will be followed by a six month wash out period for evaluating the durability of responses.
Determining the difference between the treated and placebo two-hour Area Under the Curve (AUC)-mean utilising the log (mean C-peptide+1) at the end of the treatment period for six months will be the trial’s primary objective.
Fasting and stimulated proinsulin/c-peptide ratios (a biomarker of β cell stress), C-peptide AUC, and the urine polyamine content at three, nine, and 12 month timepoints will be the secondary objectives of the trial.
Panbela president and CEO Jennifer Simpson said: “Some 1.45 million Americans are living with T1D. In the US, there are $16bn in T1D associated healthcare expenditures and lost income annually.
“Moreover, less than one-third of people with T1D in the US are consistently achieving target blood-glucose control levels.
“We are excited to move forward with the Phase II Trial, along with Indiana University and JDRF, to provide better treatment options for this patient population.”