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Sponsored by: |
University of Nebraska |
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Information provided by: | University of Nebraska |
ClinicalTrials.gov Identifier: | NCT00466518 |
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.
Condition | Intervention |
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Kidney Transplant Type 2 Diabetes |
Drug: Administration of sitagliptin |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Sitagliptin Treatment in Patients With Type 2 Diabetes Mellitus After Kidney Transplant |
Estimated Enrollment: | 20 |
Study Start Date: | April 2007 |
Estimated Study Completion Date: | December 2008 |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Administration of sitagliptin
Sitagliptin 100 mg daily for 3 months
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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.
Ages Eligible for Study: | 19 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: LuAnn R Larson, RN, BSN | 402-559-8555 | llarson@unmc.edu |
Contact: Claire Haire, RN, MSN | 402-559-5955 | chaire@unmc.edu |
United States, Nebraska | |
University of Nebraska Medical Center | Recruiting |
Omaha, Nebraska, United States, 68198-1230 | |
Principal Investigator: James T. Lane, MD |
Principal Investigator: | James T Lane, MD | University of Nebraska |
Responsible Party: | University of Nebraska Medical Center ( Dr. James Lane ) |
Study ID Numbers: | 475-06FB |
Study First Received: | April 26, 2007 |
Last Updated: | December 11, 2007 |
ClinicalTrials.gov Identifier: | NCT00466518 History of Changes |
Health Authority: | United States: Institutional Review Board |
Kidney transplant type 2 diabetes sitagliptin |
Dipeptidyl-Peptidase IV Inhibitors Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder Protease Inhibitors Sitagliptin |
Dipeptidyl-Peptidase IV Inhibitors Metabolic Diseases Molecular Mechanisms of Pharmacological Action Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Enzyme Inhibitors Glucose Metabolism Disorders Pharmacologic Actions Protease Inhibitors Sitagliptin |