Sitagliptin Treatment in Patients With Type 2 DM After Kidney Transplant

Completed · Not applicable

Conditions studied: Kidney Transplant, Type 2 Diabetes

In brief

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.

Key facts

Study ID

NCT00466518

Run by

University of Oklahoma

People needed

16

Starts

2007-04-01

Expected to finish

2011-01-01

Last updated by the study team

2026-04-07

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Type 2 Diabetes Mellitus
• Most recent HbA1C 6.5-10%
• 1 year post kidney transplant

You may not qualify if…

• 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

Where it is running

• University of Nebraska Medical Center — Omaha, Nebraska, United States

Full record on ClinicalTrials.gov

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