Outcomes of Physiologic Insulin Resensitization (PIR) in Patients With Chronic Kidney Disease and Type 2 Diabetes Mellitus

Inclusion Criteria

• •Is age 18 or older (male or female)
• •Have a documented diagnosis of CKD stage 3b, 4, or 5 and T2DM of 6 months or greater prior to screening. Patients may have treatment regimens associated with T2DM that include diabetic oral and/or injectable medications including insulin and/or GLP-1 receptor agonists.
• •In the opinion of the Investigator, has been on an appropriate, stable regimen for management of any complications present for the past six (6) months.
• •In the opinion of the Investigator, is able to do all of the following:
• •* Provide valid informed consent.
• •* Understand and comply with study procedures as presented in the consent process.
• •* Has the capacity or support to attend all required visits.
• •If female, the subject must meet either of the following sets of conditions:
• •o Is of non-childbearing potential, defined as meeting either of the following criteria:
• •Age ≥50 years and post-menopausal for at least one (1) year
• •Surgically sterile due to bilateral tubal ligation, bilateral oophorectomy, or hysterectomy
• •Is of childbearing potential and meets both of the following criteria:
• •* Has a negative serum pregnancy test (beta-human chorionic gonadotropin) at screening.
• •* Agrees to practice an acceptable method of birth control (contraception) from screening until at least 30 days after last study treatment