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NCT Number: NCT02729766

Effects of Empagliflozin an SGLT2-Inhibitor on Healthy Volunteers With Induced Hypotonic Hyponatremia - the DIVE Study

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.

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Key information

Conditions

Inappropriate ADH Syndrome Brain Diseases Central Nervous System Diseases Endocrine System Diseases Hyponatremia Hypothalamic Diseases Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Pituitary Diseases Water-Electrolyte Imbalance

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Department Endocrinology University Hospital Basel

Basel, 4031, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Induced hypotonic hyponatremia - SIAD model

Other

Other names: Induced hypotonic hyponatremia

Empagliflozin 25mg Tbl

Drug

Placebo P-Tablet

Drug

Primary outcomes

  1. 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

  1. Serum sodium concentration at every time point of the study

    Time frame: every hour for twelve hours on each of the two study days

  2. Amount of urinary excretion

    Time frame: every 2 hours for twelve hours on each of the two study days

  3. Serum osmolality at every time point of the study

    Time frame: every hour for twelve hours on each of the two study days

  4. Serum glucose at every time point of the study

    Time frame: every hour for twelve hours on each of the two study days

  5. Urinary osmolality

    Time frame: every two hours for twelve hours on each of the two study days

  6. Urinary glucose

    Time frame: every 2 hours for twelve hours on each of the two study days

  7. 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

  8. 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

  9. 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

  10. 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

  11. Plasma level of Renin 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

  12. Plasma Level of atrial natriuretic peptide (ANP) 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

  13. Plasma levels of brain natriuretic peptide (BNP) 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

  14. Body weight at every time point of the study

    Time frame: every hour during 12 hours on each of the two study days

  15. Blood pressure at every time point of the study

    Time frame: every hour during 12 hours on each of the two study days

  16. Heart rate at every time point of the study

    Time frame: every hour during 12 hours on each of the two study days

  17. Symptoms of hyponatremia assessed by visual analogue scale (VAS) at every time point of the study

    Time frame: every hour during 12 hours on each of the two study days

  18. Urinary sodium level

    Time frame: every 2 hours for twelve hours on each of the two study days

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Acronym: DIVE

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 6, 2016
Registry last updated
Aug 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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