Phase 4 N=61 Randomized Quadruple-blind Prevention

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

Posttransplant Diabetes Mellitus

Bottom Line

View on ClinicalTrials.gov: NCT01928199 ↗

Enrolled (actual)

Serious AEs

9.8%

Results posted

Jun 2021

Primary outcome: Primary: 2-hour Oral Glucose Tolerance Test-derived Blood Sugar — 141.00; 165.22 mg/dL

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Sitagliptin (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Washington University School of Medicine
Primary completion: Jun 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY 2-hour Oral Glucose Tolerance Test-derived Blood Sugar	141.00; 165.22	—
SECONDARY Normal 2-hour Oral Glucose Tolerance Test-derived Blood Sugar	16; 10	—
SECONDARY 6 Month OGTT Result (Completion of Washout From Study Drug)	174.38; 171.86	—

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.

Eligibility Criteria

Inclusion Criteria

Adult (≥18 yo) recipient of living-donor or deceased donor kidney transplant
Blood sugar ≥ 200 mg/dL in first 72 hours after transplant
No history of diabetes or prior treatment with insulin or oral hypoglycemic agents

Exclusion Criteria

A1c of ≥6.5% measured immediately pre-transplant
Recipient of simultaneous kidney-pancreas, kidney-liver, kidney-heart, or kidney-lung transplant
Prior non-renal solid organ transplant

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01928199). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.