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 Exclusion Criteria: * Has in the past two (2) years received treatment for a malignancy. * Current pregnancy or intends to become pregnant during the study * Has in the past one (1) year used non-prescription opioids or psychoactive drugs. * Has in the past six (6) months had a hypoglycemic event requiring urgent care and/or administration of glucagon, osteocalcin, or parenteral glucose, unless approved for enrollment by the Medical Monitor. * Has within the past one (1) month participated in a clinical study involving either of the following: * An investigational drug or procedure for any clinical indication * An investigation method for glucose control using approved agents * Is nursing or is planning to nurse during the study. * Has at screening a positive test for HIV (4th gen. screen), HBsAg, or HCV viral load. * Has at screening, one or more of the following abnormal lab results: * Hb \<8 g/dL * WBC \<2,000/µL * Platelets \<50,000/µL * ALT, AST, or Alkaline Phosphatase \>5x ULN * ALT or AST \>2.5x ULN, and Total Bilirubin \>2x ULN * Serum albumin \<3 g/dL * Has - in the opinion of the Investigator - psychiatric, behavioral, cognitive and/or clinical dysfunction (whether or not related to known medical illness or drug / alcohol use) that would affect the subject's safety and/or compliance. * Is on active dialysis at time of screening