Effects of the SGLT2-inhibitor Empagliflozin on Patients With SIADH

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

PHASE2/PHASE3

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-05

Study Completion Date

2019-01-14

Brief Summary

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Syndrome of inappropriate antidiuresis (SIADH) is characterized by an imbalance of antidiuretic vasopressin (AVP) secretion. The impaired AVP regulation leads to water retention and secondary natriuresis and is a common cause for hyponatremia.

The therapeutic options, aside from treating the underlying disease, depend upon the onset and severity of the symptoms and involve usually fluid restriction or hypertonic saline infusion. Alternative therapeutic options are loop diuretics, administration of oral urea or vasopressin receptor antagonists (vaptans). Despite those options, there are a considerable number of patients which do not sufficiently respond, making additional therapy necessary.

Empagliflozin (Jardiance)® is a sodium glucose co-transporter 2 (SGLT2)-inhibitor, which is a new treatment option developed for patients with diabetes mellitus type 2. The SGLT2 is expressed in the proximal tubule and reabsorbs approximately 90 percent of the filtered glucose. The inhibition of SGLT2 results in renal excretion of glucose with subsequent osmotic diuresis. This mechanism could result in a therapeutic effect in patients with hypotonic hyponatremia as in SIADH.

The aim of this study is to evaluate whether empagliflozin (Jardiance)® has an effect on the serum sodium levels of patients with SIADH.

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Detailed Description

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Conditions

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SIADH

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Empagliflozin

Treatment with empagliflozin 25mg once daily for four days

Group Type ACTIVE_COMPARATOR

Empagliflozin

Intervention Type DRUG

Placebo

Treatment with Placebo once daily for four days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Interventions

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Empagliflozin

Intervention Type DRUG

Placebo

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

\- Hyponatremia \<130mmol/l due to SIADH

Exclusion Criteria

* any Treatment for SIADH during \>48h before study start
* severe illness with ICU-Admission
* Treatment with 3% sodium Chloride (NaCl) solution
* uncontrolled hypothyroidism
* uncontrolled adrenal insufficiency
* severe renal impairment (GFR \<30ml/min), end stage renal disease
* severe hepatic impairment (Child-Pugh class C)
* systolic blood pressure \<90mmHg
* Diabetes mellitus type 1
* acute myocardial infarction or chronic venous insufficiency (CVI)
* Treatment with SGLT2 Inhibitor, Lithium Chloride or Urea
* recurrent urinary-/genital tract infections
* contraindication for lowering blood pressure
* severe immunosuppression
* pregnancy or breastfeeding
* palliative care

Minimum Eligible Age

18 Years

Maximum Eligible Age

84 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No