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

• Register: ClinicalTrials.gov
• Last refreshed on: 22 August 2016
• Main ID: NCT02729766
• Date of registration: 24/03/2016
• Prospective Registration: No
• Primary sponsor: University Hospital, Basel, Switzerland
• Public title: Effects of Empagliflozin an SGLT2-Inhibitor on Healthy Volunteers With Induced Hypotonic Hyponatremia - the DIVE Study DIVE
• Scientific title: Effects of Empagliflozin an SGLT2-Inhibitor on Healthy Volunteers With Induced Hypotonic Hyponatremia - the DIVE Study
• Date of first enrolment: March 2016
• Target sample size: 15
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02729766
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2/Phase 3

Countries of recruitment

Switzerland

Contacts

• Name: Mirjam Christ-Crain, Prof.
• Affiliation: Deputy chief division endocrinology university hospital basel

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Inappropriate ADH Syndrome

Intervention(s)

Drug: Placebo P-Tablet

Other: Induced hypotonic hyponatremia - SIAD model

Drug: Empagliflozin 25mg Tbl

Primary Outcome(s)

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 Outcome(s)

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]

Serum osmolality at every time point of the study [Time Frame: every hour 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]

Blood pressure at every time point of the study [Time Frame: every hour during 12 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]

Serum sodium concentration at every time point of the study [Time Frame: every hour for twelve hours on each of the two study days]

Body weight at every time point of the study [Time Frame: every hour during 12 hours on each of the two study days]

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]

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]

Urinary osmolality [Time Frame: every two hours for twelve hours on each of the two study days]

Urinary sodium level [Time Frame: every 2 hours 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]

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]

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]

Heart rate at every time point of the study [Time Frame: every hour during 12 hours on each of the two study days]

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]

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]

Secondary ID(s)

2015-00024

Source(s) of Monetary Support

Please refer to primary and secondary sponsors