Physiologic Insulin Resensitization compared with standard care in chronic kidney disease with type 2 diabetes

You may qualify if

• 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

You can't join if

• 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