Phase 4
Completed N=61
Efficacy Study of Sitagliptin to Prevent New-onset Diabetes After Kidney Transplant
Posttransplant Diabetes Mellitus
Source: ClinicalTrials.gov NCT01928199 ↗
Enrolled (actual)
61
Serious AEs
9.8%
Results posted
Jun 2021
Primary outcomePrimary: 2-hour Oral Glucose Tolerance Test-derived Blood Sugar — 141.00; 165.22 mg/dL
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
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 | — |
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
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. Informational only — not medical advice.