Empagliflozin in Renal Transplant Recipients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-07

Study Completion Date

2018-06-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Mellitus Renal Insufficiency Safety Issues

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Empagliflozin

10 mg once daily for 24 weeks

Group Type ACTIVE_COMPARATOR

Empagliflozin

Intervention Type DRUG

Empagliflozin tablets enclosed with red capsules (Capsugel AAEL) by Kragerø Tablettproduksjon AS for blinding purpose

Placebo

1 capsule once daily for 24 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo tablets made by Kragerø Tablettproduksjon AS and enclosed with red capsules (Capsugel AAEL) for blinding purpose

Interventions

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Empagliflozin

Empagliflozin tablets enclosed with red capsules (Capsugel AAEL) by Kragerø Tablettproduksjon AS for blinding purpose

Intervention Type DRUG

Placebo

Placebo tablets made by Kragerø Tablettproduksjon AS and enclosed with red capsules (Capsugel AAEL) for blinding purpose

Intervention Type OTHER

Other Intervention Names

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Jardiance

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No