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Can a common diabetes drug help transplant patients?

NCT ID NCT00466518

Disease control Sponsor: University of Oklahoma Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at how sitagliptin (Januvia) affects levels of anti-rejection drugs and blood sugar in 16 people who had a kidney transplant and have type 2 diabetes. Participants took sitagliptin daily for 3 months. The goal was to see if it is safe and works well in this group.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
sitagliptin (Januvia)
What this could lead to
If successful, this could show that sitagliptin is a safe and effective option to help control blood sugar in kidney transplant patients with type 2 diabetes.
What could go wrong
This is a very small, early-phase study with only 16 participants, so results may not apply to everyone. The main goal was to check drug interactions, not to prove long-term benefits or safety.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

16 people

The number who actually took part.

Start date

Apr 2007

Finished

Jan 2011

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Kidney transplant Type 2 diabetes

Contacts and locations

Locations

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198-1230, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.