Empagliflozin in Renal Transplant Recipients

Phase 4

Completed

• Conditions: Diabetes Mellitus; Renal Insufficiency; Safety Issues
• Interventions: Drug: Empagliflozin; Other: Placebo

• Registration Number: NCT03157414
• Lead Sponsor: Oslo University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-07
• Study First Submitted: 2017-03-15
• Study First Submitted QC: 2017-05-15
• Study First Posted: 2017-05-17
• Primary Completion: 2018-06-28
• Study Completion: 2018-06-28
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-13
• Last Update Posted: 2019-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Empagliflozin	Empagliflozin	10 mg once daily for 24 weeks
Placebo	Placebo	1 capsule once daily for 24 weeks

Primary Outcome Measures

Name	Time	Method
Weighted mean glucose	24 weeks	The primary endpoint will be change from baseline in weighted mean glucose at week 24 compared to placebo. Each patient will perform continuous plasma glucose monitoring (CGM, iProTM2) for 72 hours at baseline and after 24 weeks.

Secondary Outcome Measures

Name	Time	Method
Body weight	24 weeks	Change from baseline in body weight
Bone mineral density	24 weeks	Measurement of bone mineral density, using low dosage radiation (dual-energy X-ray absorptiometry (DEXA) scan) to assess the amount (grams) of mineral that are packed into a segment of bone
Glycated hemoglobin (HbA1c)	24 weeks	Change from baseline in HbA1c
Waist-hip-ratio	24 weeks	Change from baseline in waist-hip-ratio
Body composition	24 weeks	Body composition (visceral fat, metabolic measurement) will be determined using the software CoreScan (encore version 14.10, GE Healthcare) on the DEXA scans. This will allow us to analyze changes in body fat compartments to explain overall weight reduction
Blood pressure	24 weeks	Change from baseline in blood pressure, including orthostatic blood pressure
Fasting plasma glucose	24 weeks	Change from baseline in fasting plasma glucose
2 hour glucose concentration	24 weeks	Change from baseline in 2 hour glucose concentration after an oral glucose tolerance test
Arterial stiffness	24 weeks	Pulse wave velocity, using a SphygmoCor device, measuring arterial stiffness will be performed in addition to pulse wave analysis evaluating the shape and amplitude of the aortic pulse wave
Renal function	24 weeks	Renal function, defined as glomerular filtration rate (GFR), will be evaluated by creatinine and cystatin C-based estimated GFR using the chronic kidney disease epidemiology collaboration (CKD-EPI) formula. Fasting plasma creatinine and Cystatin C will be drawn at the same time and analyses will be performed at the Hospital central laboratory

Trial Locations

Locations (1)

Oslo University Hospital Rikshospitalet; 🇳🇴 Oslo, Norway