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Using Sitagliptin as a Treatment to Prevent New Onset Diabetes After Kidney Transplantation

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2009 by University of Nebraska.
Recruitment status was:  Enrolling by invitation
ClinicalTrials.gov Identifier:
First Posted: July 10, 2009
Last Update Posted: July 22, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Nebraska
This study is designed to see if the use of the drug Sitagliptin (used to reduce insulin resistance) will delay or prevent kidney transplant patients from getting diabetes.

Condition Intervention Phase
Diabetes Kidney Transplant Drug: Sitagliptin Drug: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized, Placebo-Controlled Double-Blind Trial Using Sitagliptin as a Treatment to Prevent New Onset Diabetes After Kidney Transplantation: A Pilot Study

Resource links provided by NLM:

Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • The primary objective of the study is to determine the ability of sitagliptin to prevent new-onset of diabetes after kidney transplantation. Information from this pilot study will be used to develop a larger study to test this intervention [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • The secondary objectives of the study will be to determine safety profile and tolerability of the intervention in a population of kidney transplant recipients. [ Time Frame: 1 year ]
  • AUC-glucose, AUCC-peptide, AUC-insulin will also be obtained by performing routine oral glucose tolerance testing every 3 months to give an indication of insulin resistance and beta cell function. [ Time Frame: 3 months ]

Estimated Enrollment: 40
Study Start Date: July 2009
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sitagliptin 100 mg daily Drug: Sitagliptin
Active drug dose will be 100 mg per day for estimated GFR above 50 ml/min. The dose will be decreased to 50 mg per day for estimated GFR 30-50 ml/min. The dose will be decreased further to 25 mg for those with estimated GFR below 30 ml/min or on dialysis.
Other Name: Januvia
Placebo Comparator: Placebo Drug: Placebo
Drug will be available as 100, 50, and 25 mg size with identical placebo.

Detailed Description:
New-onset diabetes after transplantation (NODAT) is a complication of solid organ transplantation. In the UNMC Kidney-Pancreas Transplant Clinic, the frequency of this complication exceeds 50% of kidney transplant recipients without diabetes prior to transplantation. NODAT is associated with increased morbidity and mortality. As this complication appears to occur rather soon after transplantation, potential preventative strategies need to be instituted soon after transplantation. Although traditional risk factors, such as family history, obesity, and minority status, explain some of the additional risk, it is thought that the immunosuppressive agents themselves are responsible for the increased risk of NODAT. The immunosuppressive agents are needed to prevent rejection, and we are left to consider additional strategies to prevent the onset of NODAT. We propose to conduct a pilot study utilizing the dipeptidyl peptidase-4 inhibitor, sitagliptin, in a randomized, double-blinded, placebo-controlled study in consecutive kidney transplant recipients at the University of Nebraska Medical Center. We have tested sitagliptin in patients with type 2 diabetes who have received a kidney transplant and have shown no major side effects or alterations in immunosuppressive drug levels. This agent is FDA-approved for the treatment of type 2 diabetes, but it has a low rate of hypoglycemia. It is thought to work by inhibiting the enzyme that naturally breaks down glucagons-like peptide-1 (GLP-1), thus increasing endogenous levels of GLP-1. GLP-1 inhibits glucagons and has stimulatory effects on beta cell function. Although the current study will treat all non-diabetic patients in the hope that NODAT is delayed or prevented, this incretin-based therapy is thought to have a low risk for hypoglycemia and other side effects. In addition, it can be safely used during low-GFR conditions. The study will attempt to recruit 40 subjects (20 sitagliptin and 20 control subjects). Patients will initiate placebo or control at 2 weeks after transplantation. Subjects will be followed in the UNMC Transplant Clinic. Initially, patients will be seen weekly and later will be followed every three months for up to 1 year. The primary outcome is the development of NODAT based on the 2003 Consensus International Guidelines. Fasting glucose levels will be followed according to usual post-transplant monitoring with testing as frequently as weekly during the recent post-transplant period and eventually going to at least monthly. Secondary outcomes include HbA1c values that will be obtained at baseline and then every three months. In addition, we will follow side effects, including hypoglycemia. The study will have a local DSMB. Consent will be obtained prior to transplantation.

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Ages Eligible for Study:   19 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Recipient of a kidney transplant at UNMC, including cadaveric or living donor transplant.

Exclusion Criteria:

  • A previous diagnosis of diabetes or previous criteria for diabetes, according to the American Diabetes Association, not previously recognized as diabetes.
  • Simultaneous transplant of another solid organ, such liver or heart.
  • Patient unable to take oral medication.
  • Patient unable to give informed consent.
  • Hypersensitivity to sitagliptin.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00936663

Sponsors and Collaborators
University of Nebraska
Principal Investigator: James T. Lane, MD University of Nebraska
  More Information

Responsible Party: James T. Lane MD, University of Nebraska Medical Center
ClinicalTrials.gov Identifier: NCT00936663     History of Changes
Other Study ID Numbers: 254-09FB
First Submitted: June 25, 2009
First Posted: July 10, 2009
Last Update Posted: July 22, 2009
Last Verified: July 2009

Keywords provided by University of Nebraska:
Kidney Transplant

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action