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

Tracking Information
First Submitted Date  ICMJE April 26, 2007
First Posted Date  ICMJE April 27, 2007
Last Update Posted Date June 5, 2017
Study Start Date  ICMJE April 2007
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 6, 2007)
Changes in pharmacokinetics [ Time Frame: 3 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 26, 2007)
  • Change in HbA1.
  • Side effect profiles.
  • Change in immunosuppressive drug levels.
  • Determine tolerability in post kidney transplant patients.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 6, 2007)
  • 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 ]
  • To determine the effect of sitagliptin on glucose lowering over 3 months as measured by the change in HgbA1c. [ Time Frame: 3 months ]
  • To determine if the addition of sitagliptin changes tacrolimus or sirolimus drug levels in post-kidney transplant patients [ Time Frame: 3 months ]
  • Determine tolerability of sitagliptin therapy in post-kidney transplant patients. [ Time Frame: 3 months ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sitagliptin Treatment in Patients With Type 2 DM After Kidney Transplant
Official Title  ICMJE Sitagliptin Treatment in Patients With Type 2 Diabetes Mellitus After Kidney Transplant
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Kidney Transplant
  • Type 2 Diabetes
Intervention  ICMJE Drug: Administration of sitagliptin
Sitagliptin 100 mg daily for 3 months
Other Name: Januvia
Study Arms  ICMJE Experimental: 1
Intervention: Drug: Administration of sitagliptin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 2, 2017)
16
Original Estimated Enrollment  ICMJE
 (submitted: April 26, 2007)
20
Actual Study Completion Date  ICMJE January 2011
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00466518
Other Study ID Numbers  ICMJE 475-06-FB
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Oklahoma
Study Sponsor  ICMJE University of Oklahoma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: James T Lane, MD University of Nebraska
PRS Account University of Oklahoma
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP