OTHER
Effects of Empagliflozin an SGLT2-Inhibitor on Healthy Volunteers With Induced Hypotonic Hyponatremia - the DIVE Study
Status
Completed
Phase
Phase 2 / Phase 3
Enrollment
15
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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 the syndrome of inappropriate antidiuretic hormone (ADH) secretion (SIAD). Because patients with SIAD usually have several comorbidities and different medications, studies investigating the physiological effects are difficult to interpret. Therefore a model to study the possible physiological effect of SGLT2-inhibitors in hypotonic hyponatremia as in SIAD is needed. The aim of this study is to evaluate whether empagliflozin (Jardiance)® has an effect on serum sodium levels of healthy volunteers with induced hypotonic hyponatremia.
Interventions
Treatment arms and agents.
DRUG
Empagliflozin 25mg Tbl
DRUG
Placebo P-Tablet
Timeline
From registration to results.
First posted
Apr 6, 2016
Study start
Mar 2016
Primary completion
Jul 2016
Study completion
Aug 2016
Results posted
Not reported
Registry updated
Aug 10, 2016
Outcomes
What the study measures.
Primary outcomes
The primary outcome is the area under the curve (AUC) of the serum sodium concentration between time points 2 and 8 hours after administration of the study drug.
Time frame · concentration measured every hour within 8 hours after drug administration on both study days
Secondary outcomes
Serum sodium concentration at every time point of the study
Time frame · every hour for twelve hours on each of the two study days
Amount of urinary excretion
Time frame · every 2 hours for twelve hours on each of the two study days
Serum osmolality at every time point of the study
Time frame · every hour for twelve hours on each of the two study days
Serum glucose at every time point of the study
Time frame · every hour for twelve hours on each of the two study days
Urinary osmolality
Time frame · every two hours for twelve hours on each of the two study days
Urinary glucose
Time frame · every 2 hours for twelve hours on each of the two study days
Serum electrolytes at time point -1, 0, 2 and 8
Time frame · 1 hour before induction of siad, at baseline, 2 hours and 8 hours after administration of study medication on each study day
Urinary electrolytes at time point -1, 0, 2 and 8
Time frame · 1 hour before induction of siad, at baseline, 2 hours and 8 hours after administration of study medication on each study day
Plasma level of Copeptin at time point -1, 0, 2 and 8
Time frame · 1 hour before induction of siad, at baseline, 2 hours and 8 hours after administration of study medication on each study day
Plasma level of Aldosterone at time point -1, 0, 2 and 8
Time frame · 1 hour before induction of siad, at baseline, 2 hours and 8 hours after administration of study medication on each study day
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 65 Years
- Sex
- ALL
- Healthy volunteers
- Yes
Inclusion Criteria: * Informed consent as documented by signature * Age 18 to 65 years * serum sodium level 135-145mmol/l * clinically euvolemic status Exclusion Criteria: * Known or suspected allergy to trial product or related products * Pregnancy or breast feeding * Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant * Participation in another study with investigational drug within the 30 days preceding and during the present study * Enrolment of the investigator, his/her family members, employees and other dependent persons * untreated hypothyroidism * cortisol deficiency * history of heart failure * liver cirrhosis at any stage * kidney disease (GFR \<60ml/min) * epileptic seizures within the last year * uncontrolled hypertension (systolic blood pressure \>160mmHg) * Diabetes mellitus type 1 or 2 * BMI \<18 or \>29kg/m2 * other severe disease
Study locations
1 registered sites.
Switzerland. Showing up to 24 locations stored in the fast local snapshot.
Department Endocrinology University Hospital Basel
Basel, Basel, Switzerland
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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