Clinical trial NCT03157414: Empagliflozin in Renal Transplant Recipients
Official title: Efficacy and Safety of Empagliflozin in Renal Transplant Recipients With Post-transplantation Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus
Renal Insufficiency
Safety Issues
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2017-05-17
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a single-center, prospective, controlled, double-blind, randomized study. A total of 50 renal transplant recipients diagnosed with post-transplantation diabetes mellitus (PTDM) will be included more than 1 year after transplantation and randomized 1:1 to empagliflozin (Jardiance®) 10 mg or placebo once daily for 24 weeks. Patients with estimated glomerular filtration rate below 30 mL/min will be excluded. Oral glucose tolerance test, 72h continuous glucose monitoring (iPro™2), measurement of arterial stiffness, body composition (including visceral fat), 24h blood pressure and 24h urinary glucose excretion will be performed at baseline and after 24 weeks in addition to standard safety measurements. Two safety visits will be performed at week 8 and 16. All concomitant medication, diet and exercise will be kept stable during the study period. The objective of the present study is to answer whether empagliflozin safely and effectively improves glucose metabolism together with weight loss in renal transplant recipients with PTDM.


Eligibility criteria: Inclusion Criteria:

* Renal transplant recipient transplanted more than 1 year ago
* Stable renal function (\<20% deviation in serum creatinine within last 2 months)
* Stable immunosuppressive therapy ≥3 months before inclusion
* Diagnosed with PTDM:

(fasting plasma glucose ≥7.0 mmol/l and/or 2-hour plasma glucose ≥11.1 mmol/l following an oral glucose tolerance test)

-Signed informed consent and expected cooperation of the patients

Exclusion Criteria:

* Estimated GFR \<30 ml/min/1.73 m2
* Pregnant or nursing mothers
* Hypersensitivity to the active substance (IMP) or to any of the excipients
* Any reason why, in the opinion of the investigator, the patient should not participate

Primary outcomes:
measure: Weighted mean glucose
timeFrame: 24 weeks
Secondary outcomes:
measure: Fasting plasma glucose
timeFrame: 24 weeks
measure: 2 hour glucose concentration
timeFrame: 24 weeks
measure: Glycated hemoglobin (HbA1c)
timeFrame: 24 weeks
measure: Body weight
timeFrame: 24 weeks
measure: Waist-hip-ratio
timeFrame: 24 weeks
measure: Bone mineral density
timeFrame: 24 weeks
measure: Body composition
timeFrame: 24 weeks
measure: Blood pressure
timeFrame: 24 weeks
measure: Arterial stiffness
timeFrame: 24 weeks
measure: Renal function
timeFrame: 24 weeks
Other outcomes:
measure: Incidence of abnormal trough levels of immunosuppressive drugs
timeFrame: 24 weeks
measure: Adverse event
timeFrame: 24 weeks
measure: Urinary glucose excretion
timeFrame: 24 weeks
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital Rikshospitalet
Study officials:
References:
citation: Lo C, Toyama T, Oshima M, Jun M, Chin KL, Hawley CM, Zoungas S. Glucose-lowering agents for treating pre-existing and new-onset diabetes in kidney transplant recipients. Cochrane Database Syst Rev. 2020 Jul 30;8(8):CD009966. doi: 10.1002/14651858.CD009966.pub3.
citation: Halden TAS, Kvitne KE, Midtvedt K, Rajakumar L, Robertsen I, Brox J, Bollerslev J, Hartmann A, Asberg A, Jenssen T. Efficacy and Safety of Empagliflozin in Renal Transplant Recipients With Posttransplant Diabetes Mellitus. Diabetes Care. 2019 Jun;42(6):1067-1074. doi: 10.2337/dc19-0093. Epub 2019 Mar 12.