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Sitagliptin Treatment in Patients With Type 2 DM After Kidney Transplant

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. Identifier: NCT00466518
Recruitment Status : Completed
First Posted : April 27, 2007
Last Update Posted : June 5, 2017
Information provided by (Responsible Party):
University of Oklahoma

Brief 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.

Condition or disease Intervention/treatment Phase
Kidney Transplant Type 2 Diabetes Drug: Administration of sitagliptin Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sitagliptin Treatment in Patients With Type 2 Diabetes Mellitus After Kidney Transplant
Study Start Date : April 2007
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1 Drug: Administration of sitagliptin
Sitagliptin 100 mg daily for 3 months
Other Name: Januvia

Primary Outcome Measures :
  1. Changes in pharmacokinetics [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. To determine if there is a change in side effects with the addition of sitagliptin to the post-kidney transplant treatment regime. [ Time Frame: 3 months ]
  2. To determine the effect of sitagliptin on glucose lowering over 3 months as measured by the change in HgbA1c. [ Time Frame: 3 months ]
  3. To determine if the addition of sitagliptin changes tacrolimus or sirolimus drug levels in post-kidney transplant patients [ Time Frame: 3 months ]
  4. Determine tolerability of sitagliptin therapy in post-kidney transplant patients. [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00466518

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United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-1230
Sponsors and Collaborators
University of Oklahoma
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Principal Investigator: James T Lane, MD University of Nebraska
Additional Information:
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Responsible Party: University of Oklahoma Identifier: NCT00466518    
Other Study ID Numbers: 475-06-FB
First Posted: April 27, 2007    Key Record Dates
Last Update Posted: June 5, 2017
Last Verified: June 2017
Keywords provided by University of Oklahoma:
Kidney transplant
type 2 diabetes
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
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