The purpose of this research is to evaluate outcomes of physiologic insulin re-sensitization (PIR) in patients with Chronic Kidney Disease (CKD) and Type 2 Diabetes Mellitus (T2DM).

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

Data sharing plan is to be determined.