Outcomes of Physiologic Insulin Resensitization (PIR) in Patients With Chronic Kidney Disease and Type 2 Diabetes Mellitus
NCT ID: NCT07187479
Last Updated: 2025-10-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2025-10-14
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Physiologic Insulin Resensitization (PIR) Group
Subject to receive Physiologic Insulin Resensitization (PIR)
Physiologic Insulin Resensitization (PIR)
PIR is a physician-directed treatment that uses an exterior infusion pump to deliver insulin intravenously.
Standard of Care (SOC) Group
Subjects will receive standard of care
No interventions assigned to this group
Interventions
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Physiologic Insulin Resensitization (PIR)
PIR is a physician-directed treatment that uses an exterior infusion pump to deliver insulin intravenously.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Well Cell Global
INDUSTRY
Responsible Party
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Principal Investigators
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Sungchun Lee, MD
Role: PRINCIPAL_INVESTIGATOR
Arizona Kidney Disease and Hypertension Centers
Locations
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Arizona Kidney Disease and Hypertension Center
Phoenix, Arizona, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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AZ-01
Identifier Type: -
Identifier Source: org_study_id
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