Sitagliptin Treatment in Patients With Type 2 DM After Kidney Transplant
Sitagliptin Treatment in Patients With Type 2 DM After Kidney Transplant
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:

 1. It is administered orally once a day

 2. Nausea occurred at a rate of only 1.4%

 3. Its potential of hypoglycemia is low

 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.
Inclusion Criteria:

 -  Type 2 Diabetes Mellitus

 -  Most recent HbA1C 6.5-10%

 -  1 year post kidney transplant

 Exclusion Criteria:

 -  Patients treated primarily with insulin for their diabetes

 -  Kidney allograft not functional at entry or estimated creatinine clearance of <30
 ml/min

 -  Clinical course complicated by persistent nausea

 -  severe gastroparesis

 -  Severe recurrent hypoglycemia (>1 hypoglycemic episode requiring the help of another
 person per week).

 -  Patients on dialysis therapy

 -  Unstable renal function in the preceding 3 months

 -  Serum transaminases >2 times normal at study entry

 -  Smokers

 -  Pregnant or planning to become pregnant

 -  Lactating

 -  Recipients of multi-organ transplants

 -  Unstable medical conditions which result in multiple hospitalizations or a severely
 restricted lifestyle

 -  Hemoglobin <10.0g/dl

 -  Use of digoxin

 -  Patients receiving their primary care outside of UNMC

 -  Inability to come to follow-up visits as a part of the protocol

 -  Patients not taking tacrolimus and sarolimus as part of their immunosuppressive
 therapy