Kidney TransplantNCT00466518
Sitagliptin Treatment in Patients With Type 2 DM After Kidney Transplant
A study testing Administration of sitagliptin in people with Kidney Transplant and Type 2 Diabetes, run by University of Oklahoma at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Kidney Transplant, Type 2 Diabetes
- What is being tested?
- Administration of sitagliptin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Jan 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 Diabetes Mellitus
- Most recent HbA1C 6.5-10%
- 1 year post kidney transplant
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68198-1230
About this study
Official title: Sitagliptin Treatment in Patients With Type 2 Diabetes Mellitus After Kidney Transplant
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.
Read the 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:
- It is administered orally once a day
- Nausea occurred at a rate of only 1.4%
- 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.
- Conditions
- Kidney Transplant, Type 2 Diabetes
- Being tested
- Administration of sitagliptin
- Keywords
- Kidney transplant, type 2 diabetes, sitagliptin
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of sitagliptinDrug
Also called Januvia
Sitagliptin 100 mg daily for 3 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Administration of sitagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in pharmacokinetics
Measured: 3 months
Secondary outcomes (4)
To determine if there is a change in side effects with the addition of sitagliptin to the post-kidney transplant treatment regime.
Measured: 3 months
To determine the effect of sitagliptin on glucose lowering over 3 months as measured by the change in HgbA1c.
Measured: 3 months
To determine if the addition of sitagliptin changes tacrolimus or sirolimus drug levels in post-kidney transplant patients
Measured: 3 months
Determine tolerability of sitagliptin therapy in post-kidney transplant patients.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2007 (estimated)
- Study startApr 2007
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James T Lane, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00466518
- Sponsor's protocol ID
- 475-06-FB-Pilot
- Status last verified
- Apr 2026
- First submitted
- 26 Apr 2007
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sitagliptin Treatment in Patients With Type 2 Diabetes Mellitus After Kidney Transplant
- ClinicalTrials.gov ID
- NCT00466518
- Acronym / sponsor ID
- 475-06-FB-Pilot
- Conditions
- Kidney Transplant, Type 2 Diabetes
- Keywords
- Kidney transplant, type 2 diabetes, sitagliptin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 27 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- It is administered orally once a day
- Nausea occurred at a rate of only 1.4%
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Administration of sitagliptin |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type 2 Diabetes Mellitus
- Most recent HbA1C 6.5-10%
- 1 year post kidney transplant
Key exclusion criteria (18 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Administration of sitagliptinAlso: JanuviaSitagliptin 100 mg daily for 3 months | Drug | 1 |
Primary outcome
Changes in pharmacokinetics
Time frame: 3 months
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James T Lane, MD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Administration of sitagliptin in people with Kidney Transplant and Type 2 Diabetes, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in pharmacokinetics (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.