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

The primary objective of this study is to assess the outcomes of Physiologic Insulin Resensitization (PIR) treatment compared to standard of care (SOC) on renal patients with a diagnosis of chronic kidney disease (CKD) (stages 3b, 4 and 5) and Type 2 diabetes mellitus (T2DM)

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