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Sitagliptin Treatment in Patients With Type 2 DM After Kidney Transplant

StatusCompleted
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Amendment history

  1. Minor

    Study Identification, Study Status

    Re-verified, no change to tracked fields

    v6

  2. Notable

    Lead sponsor: University of Nebraska to University of Oklahoma

    Primary and study completion dates changed from estimate of Mar 2010 to Jan 2011; Trial status: Active, Not Recruiting to Completed; Enrollment target: estimated 20 to confirmed 16

    Study Identification, Study Status, Sponsor/Collaborators, Study Designv5

  3. Minor

    Trial status: Recruiting to Active, Not Recruiting

    Primary completion date: Mar 2010; Completion date: Dec 2008 to Mar 2010; Site details revised

    Study Identification, Study Status, Contacts/Locationsv4

  4. Minor

    Study arms: 0 to 1

    Study Status, Sponsor/Collaborators, Arms and Interventionsv3

  5. Notable

    Primary endpoints: 4 to 1

    Eligibility criteria revised; Secondary endpoints expanded, about 66 words; Study description revised

    Show what changed: Primary endpoints
    ChangeChanges in HbA1. Change in immunosuppressive drug levels. Determine tolerability in post kidney transplant patients. Side effect profiles.pharmacokinetics
    Show what changed: Eligibility criteria
    [...] esult in multiple hospitalizations or a severely restricted lifestlyelifestyle Hemoglobin <10.0g/dl Use of digoxin Patients receiving thei [...]
    Show what changed: Secondary endpoints
    To determine if there is a change in side effects with the addition of sitagliptin to the post-kidney transplant treatment regime. To determine the effect of sitagliptin on glucose lowering over 3 months as measured by the change in HgbA1c. To determine if the addition of sitagliptin changes tacroli [...]
    Show what changed: Study description
    [...] ycemia, given the high frequency of PTDM in the post-kidney trasplanttransplant population.

    Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibilityv2

  6. Minor

    Study First Submitted

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
University of Oklahoma
162 trials monitored
See 8 trials at risk
Diabetes
4,286 trials monitored
See 187 trials at risk
Type 2 Diabetes
2,100 trials monitored
See 102 trials at risk
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.
Trial Details
NCT Number NCT00466518
Lead Sponsor University of Oklahoma
Conditions Kidney Transplant, Type 2 Diabetes
Enrollment 16 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov