An interventional study of Administration of sitagliptin in Kidney Transplant and Type 2 Diabetes, sponsored by University of Oklahoma. Completed at 1 site in United States. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-04-07.
Sponsored by University of Oklahoma · Not applicable, Interventional, and Treatment
This study is designed to look at the effect sitagliptin has on tacrolimus and sirolimus drug levels in kidney transplant patients. It is also designed to look at the side effects experienced in the transplant population.
Within the last six months, the FDA has approved sitagliptin phosphate as an oral drug that potentiates the effect of native GLP-1 through inhibition of DPP-4. It is approved for treatment of type 2 diabetes in adults as monotherapy or in combination with metformin or a TZD. It has several advantages over extenatide when considering its use in kidney transplant recipients:
However, it may not be as potent, in terms of HbA1C with % change in HbA1C\<1%. In addition there is not a lot of information on gastric emptying, although this is probably not as severe as exenatide, with fewer symptoms of nausea reported.
We propose to conduct a pilot study for using sitagliptin in patients who have both type 2 diabetes and who have received a kidney transplant. Our objectives are to study the effect of sitagliptin administration on side effect profiles, change in HbA1C, and the percentage of patients who require discontinuation of the drug as a result of major changes in immunosuppressant drug levels. The data will be used as preliminary data for a larger study that attempts to prevent or delay the onset of PTDM in kidney transplant recipients. We anticipate treating patients with both impaired fasting glucose and normoglycemia, given the high frequency of PTDM in the post-kidney transplant population.
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's enrollment of 16 is below the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →University of Oklahoma is the lead sponsor of 424 studies on the registry; 99 are open to participants now.
Of its 42 completed or terminated interventional studies of FDA-regulated products, 16 (38%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Administration of sitagliptin
Sitagliptin 100 mg daily for 3 months
Also known as: Januvia
Changes in pharmacokinetics
Time frame: 3 months
To determine if there is a change in side effects with the addition of sitagliptin to the post-kidney transplant treatment regime.
Time frame: 3 months
To determine the effect of sitagliptin on glucose lowering over 3 months as measured by the change in HgbA1c.
Time frame: 3 months
To determine if the addition of sitagliptin changes tacrolimus or sirolimus drug levels in post-kidney transplant patients
Time frame: 3 months
Determine tolerability of sitagliptin therapy in post-kidney transplant patients.
Time frame: 3 months
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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University of Oklahoma