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Empagliflozin in Renal Transplant Recipients — EMPA-RenalTx  

Diabetes Mellitus Clinical Trial

Official title:
Efficacy and Safety of Empagliflozin in Renal Transplant Recipients With Post-transplantation Diabetes Mellitus

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03157414
Study type Interventional
Source Oslo University Hospital
Contact
Status Completed
Phase Phase 4
Start date November 7, 2016
Completion date June 28, 2018
View Details
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