TerminatedPhase 4

Efficacy and Safety of Empagliflozin in NODAT

Stopped: Difficult in enrolling suitable participants

China6 participantsStarted 2018-07-14

Plain-language summary

This is an open label, randomized controlled study. We'd like to access the safety and effects of empagliflozin compared with linagliptin in new-onset diabetes after kidney transplantation patients. Our primary endpoints are kidney related indicators and secondary endpoints are glucose and lipid metabolism related indicators and adverse events. We are going to recruit 35 patients for each group and follow six months.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Single kidney transplantation * Normal glucose tolerance or Pre-Diabetes mellitus before transplantation * According to Oral glucose tolerance test results to make the diagnosis of NODAT * Standard triple immunosuppression therapy * HbA1c≤10% * Steady hormone usage * BMI 18.5-30kg/m2 * Patient informed consent Exclusion Criteria: * Diabetes patients before transplantation * Pregnancy pregnancy * Type 1 diabetes after kidney transplantation * Severe liver function impairment (AST/ALT 3 times standard value) * Severely impaired renal function (eGFR\<45) * Having uncontrolled diseases * History of cancer in the past 5 years (except basal cell carcinoma) and/or cancer treatment * Participating in another trial involving the study drug with in 30 days * Premenopausal women (1 year before the last menstrual period ≤ informed consent) * Alcohol or drug abuse within 3 months of informed consent, affecting compliance Need other drugs to control NODAT

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

eGFR

Timeframe: 24 weeks

Trial details

NCT IDNCT03642184

SponsorRenJi Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-01-31

View on ClinicalTrials.gov More New Onset Diabetes After Transplant trials