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 range18 Years – 65 Years

SexALL

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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

What they're measuring

eGFR

Timeframe: 24 weeks

Trial details

NCT IDNCT03642184

SponsorRenJi Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-01-31