Overview

Sitagliptin Treatment in Patients With Type 2 DM After Kidney Transplant

Status:
Completed
Trial end date:
2011-01-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Nebraska
University of Oklahoma
Treatments:
Sitagliptin Phosphate
Criteria
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