Physiologic insulin resensitization for adults with stage 3b–5 chronic kidney disease and type 2 diabetes
Randomized, Open Label Study to Examine the Outcomes of Physiologic Insulin Resensitization in Patients With Chronic Kidney Disease and Type 2 Diabetes Mellitus
This trial will test whether physiologic insulin resensitization (PIR) helps adults with stage 3b–5 chronic kidney disease and type 2 diabetes do better than standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Well Cell Global Industry-sponsored |
| Locations | 1 site (Phoenix, Arizona) |
| Trial ID | NCT07187479 on ClinicalTrials.gov |
What this trial studies
This interventional study compares physiologic insulin resensitization (PIR) to standard of care in adults with CKD stages 3b–5 and type 2 diabetes. Eligible participants are 18 or older, have T2DM for at least six months, and are on a stable regimen for complications; permitted diabetes therapies include oral agents, insulin, or GLP‑1 receptor agonists. PIR delivers patterned insulin intended to restore physiologic insulin signaling alongside routine nephrology management according to the study protocol. The study will track kidney-related outcomes and measures of diabetes control and compare results between the PIR and standard-care groups.
Who should consider this trial
Good fit: Adults aged 18 or older with stage 3b, 4, or 5 chronic kidney disease and a diagnosis of type 2 diabetes for at least six months who are on a stable treatment regimen.
Not a fit: People without type 2 diabetes, those with earlier-stage CKD, individuals with unstable medical regimens or conditions that prevent attending the Phoenix clinic, and pregnant or childbearing-potential people are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, PIR could improve glucose control and slow decline in kidney function for people with type 2 diabetes and advanced CKD.
How similar studies have performed: Small pilot studies and case reports of patterned insulin approaches have shown preliminary metabolic benefits, but large randomized trials in CKD populations are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Phoenix, Arizona
- Arizona Kidney Disease and Hypertension Center — Phoenix, Arizona, United States (Recruiting)
Study contacts
- Principal investigator: Sungchun Lee, MD — Arizona Kidney Disease and Hypertension Centers
- Study coordinator: Richard Marchase, PhD
- Email: rmarchase@gmail.com
- Phone: 205-612-4763
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.