Q. Visit clinicaltrials.

gov or any WHO trial registry and search Empagliflozin Efficacy & Safety
Study and share one project in Pdf template

Ubiquitous glucose-6-phosphatase deficiency (G6PC3) and glucose-6-phosphate transporter

deficiency (G6PT/SLC37A4) both cause neutropenia. Studies on a G6PC3 deficient mouse model
by Dr Veiga-da-Cunha and Prof. Van Schaftingen and colleagues have shown that these two
proteins collaborate to hydrolyze a metabolite that exerts toxic effects on neutrophils. This
metabolite is 1,5-anhydroglucitol-6-phosphate. It is formed by phosphorylation of a glucose
analogue, 1,5-anhydroglucitol, which is present in the blood of all humans, mice and other
mammals.

Empagliflozin (marketed in Belgium under the name of Jardiance®) belongs to the class of drugs
called oral hypoglycemic agents. It works on the kidney by inhibiting the glucose transporter in
the proximal tubules, SGLT2, which leads to glucosuria that results in the elimination of 1,5-
anhydroglucitol in the urine. At present, Empagliflozin alone or in combination with other drugs is
commonly used in people with type 2 diabetes to control their blood sugar levels.

EMPAGLIFOZIN SAFETY:

Empagliflozin safety (blood test-glycemia): measured by absence of hypoglycaemia due to

gliflozin treatment [ Time Frame: from start of treatment to 2 months post treatment ]

Empagliflozin safety is measured by absence of hypoglycemia due to gliflozin treatment

(continuous monitoring during the first 2 days of treatment and glycemia punctual monitoring
every 7 days for 2 months) (mg/dl) .

Empaglifozin EFFICACY :

 Empaglifozin Efficacy (blood test-hemogram) [ Time Frame: from start of treatment to 2

months post treatment ]
o Efficacy of drug is measured by an Increased neutrophil count as compared to pre-
treatment (10exp3/µl)
 Empaglifozin Clinical efficacy (questionnaire) [ Time Frame: from start of treatment to 2
monthps post treatment ]
o Empaglifozin Clinical efficacy is measured as a Decrease in the number of
infections
o -Decrease in the number of episodes of oral aphtosis (stomatitis) We will use
numerical scale: higher scores mean worse outcome

 Empaglifozin Biological efficacy on blood 1,5-anhydroglucitol level (blood test-LCMS)

[ Time Frame: from start of treatment to 2 months post treatment ]
 o Empaglifozin Biological efficacy is measured as a Decrease of blood 1,5-
anhydroglucitol (µM)

 Empaglifozin Biological efficacy on 1,5-anhydroglucitol-6-phosphate levels in neutrophils

(blood test-LCMS) [ Time Frame: from start of treatment to 2 months post treatment ]
o Empaglifozin Biological efficacy is measured as decrease in the level of 1,5-
anhydroglucitol-6-phosphate in neutrophils (µM)

 Empaglifozin Clinical efficacy on urinary 1,5-anhydroglucitol excretion increase (urine

test-LCMS) [ Time Frame: from start of treatment to 2 months post treatment ]
o Empaglifozin Biological efficacy is measured as increased excretion of urinary 1,5-
anhydroglucitol (µM)

 Empaglifozin Clinical efficacy on neutrophil function (blood test) [ Time Frame: from start
of treatment to 2 months post treatment ]
o Empaglifozin Biological efficacy is measured as improved neutrophilic function
(glycosylation analysis, Western Blot)