Efficacy Study of Sitagliptin to Prevent New-onset Diabetes After Kidney Transplant

• Status: Completed
• Trial end date: 2020-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether sitagliptin is effective in preventing the development of new-onset diabetes after kidney transplant (NODAT). Up to one-third of previously non-diabetic patients develop NODAT after a kidney transplant. Corticosteroids and calcineurin inhibitors are two commonly utilized anti-rejection medications that contribute to diabetes development through multiple mechanisms; including decreased insulin production by the pancreas. Sitagliptin is an oral medication that results in increased insulin secretion. We hypothesize that administration of sitagliptin to transplant recipients identified to be at risk for diabetes development will reduce the incidence and severity of NODAT.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Sitagliptin Phosphate

Criteria

Inclusion Criteria:

1. Adult (≥18 yo) recipient of living-donor or deceased donor kidney transplant

2. Blood sugar ≥ 200 mg/dL in first 72 hours after transplant

3. No history of diabetes or prior treatment with insulin or oral hypoglycemic agents

Exclusion Criteria:

1. A1c of ≥6.5% measured immediately pre-transplant

2. Recipient of simultaneous kidney-pancreas, kidney-liver, kidney-heart, or kidney-lung transplant

3. Prior non-renal solid organ transplant