Sitagliptin Treatment in Patients With Type 2 DM After Kidney Transplant

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by University of Nebraska.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Nebraska
ClinicalTrials.gov Identifier:
NCT00466518
First received: April 26, 2007
Last updated: January 11, 2010
Last verified: January 2010
  Purpose

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
Kidney Transplant
Type 2 Diabetes
Drug: Administration of sitagliptin

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Sitagliptin Treatment in Patients With Type 2 Diabetes Mellitus After Kidney Transplant

Resource links provided by NLM:


Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • Changes in pharmacokinetics [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • To determine the effect of sitagliptin on glucose lowering over 3 months as measured by the change in HgbA1c. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • To determine if the addition of sitagliptin changes tacrolimus or sirolimus drug levels in post-kidney transplant patients [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Determine tolerability of sitagliptin therapy in post-kidney transplant patients. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: April 2007
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Administration of sitagliptin
Sitagliptin 100 mg daily for 3 months
Other Name: Januvia

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00466518

Locations
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-1230
Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: James T Lane, MD University of Nebraska
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. James Lane, University of Nebraska Medical Center
ClinicalTrials.gov Identifier: NCT00466518     History of Changes
Other Study ID Numbers: 475-06-FB
Study First Received: April 26, 2007
Last Updated: January 11, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Nebraska:
Kidney transplant
type 2 diabetes
sitagliptin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 23, 2014