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

Summary

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).

Eligibility

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

Conditions4

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