natgillin/translations-raw huggingface dataset:
Supplemental carbohydrate may be required based on glucose levels in addition to hydration and additional rapid acting insulin (see Table 1 in section 4.2). 
Glede na koncentracijo glukoze v krvi so lahko poleg hidracije in dodatnega hitrodelujočega insulina potrebni dodatni ogljikovi hidrati (glejte preglednico 1 in poglavje 4.2).
In the study 50% were male and 88 % were White and 87% of randomised patients completed the study. 
V študiji je bilo 50 % moških in 88 % belcev; študijo je dokončalo 87 % randomiziranih bolnikov.
EU/1/19/1363/008 200 film-coated tablets (2 packs of 100) 
EU/0/00/000/008 200 filmsko obloženih tablet (2 pakiranji po 100)
• Patient Alert Card 
• Opozorilne kartice za bolnika
• Sotagliflozin treatment should be temporarily stopped before surgical procedures or in case of hospitalisation for acute serious illness. 
• Zdravljenje s sotagliflozinom je treba začasno prekiniti pred kirurškimi posegi ali v primeru hospitalizacije zaradi akutne resne bolezni.
Oval, blue, film-coated tablet printed with “2456” on one side in black ink (tablet length: 14.2 mm, tablet width: 8.7 mm). 
Filmsko obložene tablete ovalne oblike in modre barve, ki imajo na eni strani s črnim črnilom natisnjeno oznako "2456" (dolžina tablete 14,2 mm, širina tablete: 8,7 mm).
Table 2: Tabulated list of adverse reactions System Organ class 
Preglednica 2: Seznam neželenih učinkov v preglednici
Table 7: Incidence of severe hypoglycaemia and rates of documented, (overall and nocturnal) hypoglycaemic events in the pool of two 52-week placebo-controlled clinical studies Insulin (N=526) 
Preglednica 7: Pojavnost hudih hipoglikemij in deleži dokumentiranih (vseh in nočnih) hipoglikemij v združenih podatkih dveh 52-tedenskih, s placebom kontroliranih kliničnih študij
No data in humans are available on excretion of sotagliflozin into milk. 
Pri človeku ni podatkov o izločanju sotagliflozina v materino mleko.
- When needed to prevent hypoglycaemia, insulin dose reduction should be done cautiously to avoid ketosis and DKA (see section 4.2). 
- Če je treba odmerek insulina za preprečitev hipoglikemij zmanjšati, je zmanjšanje treba izvesti previdno, da bi se izognili ketozi in DKA (glejte poglavje 4.2).
o Is adequately informed about managing sick days. 
o ustrezno obveščen z vodenjem bolniških odsotnosti.
The overall frequency of urinary tract infections reported were 7.1% and 5.5% for sotagliflozin 200 mg and sotagliflozin 400 mg compared to 6.1% for placebo. 
Okužbe sečil Celokupna pogostnost poročanih okužb sečil je bila 7,1 % in 5,5 % z 200 mg sotagliflozina in 400 mg sotagliflozina, v primerjavi s 6,1 % s placebom.
Sotagliflozin is not recommended in patients with moderate and severe hepatic impairment, as sotagliflozin exposure is increased in these patients (see sections 4.2 and 5.2). 
Za bolnike z zmerno in hudo okvaro jeter sotagliflozin ni priporočljiv, ker je izpostavljenost sotagliflozinu pri teh bolnikih večja (glejte poglavji 4.2 in 5.2).
In a rat carcinogenicity study, a statistically significant increase in thyroid follicular cell carcinoma was observed in males at 75 mg/kg/day, approx. 14 times the MRHD, the highest dose evaluated. 
5.3 Predklinični podatki o varnosti V študiji karcinogenosti pri podganah so opažali statistično značilno povečanje karcinoma ščitničnih folikularnih celic pri samcih z odmerkom 75 mg/kg/dan, kar je približno 14-krat toliko kot največji priporočeni odmerek za človeka (MRHD - maximum recommended human dose), ki je bil največji ocenjevani odmerek.
When needed, insulin dose reduction should be done cautiously to avoid ketosis and DKA. 
Ko je zmanjšanje odmerka insulina potrebno, ga je treba izvesti previdno, da bi preprečili nastanek ketoze in DKA.
The median Tmax ranged from 1.25 to 3 hours, over a single-dose range of 400 to 2000 mg. 
Mediani tmax je v razponu enkratnih odmerkov od 400 do 2000 mg segal od 1,25 do 3 ure.
EU/1/19/1363/001 (200 mg - 10 film coated tablets) EU/1/19/1363/002 (200 mg - 20 film coated tablets) EU/1/19/1363/003 (200 mg - 30 film coated tablets) EU/1/19/1363/004 (200 mg - 60 film coated tablets) EU/1/19/1363/005 (200 mg - 90 film coated tablets) EU/1/19/1363/006 (200 mg - 100 film coated tablets) EU/1/19/1363/007 (200 mg - 180 film coated tablets) 
EU/0/00/000/001 (200 mg - 10 filmsko obloženih tablet) EU/0/00/000/002 (200 mg - 20 filmsko obloženih tablet) EU/0/00/000/003 (200 mg - 30 filmsko obloženih tablet) EU/0/00/000/004 (200 mg - 60 filmsko obloženih tablet) EU/0/00/000/005 (200 mg - 90 filmsko obloženih tablet) EU/0/00/000/006 (200 mg - 100 filmsko obloženih tablet) EU/0/00/000/007 (200 mg - 180 filmsko obloženih tablet)
Exposure at the rat no-observedeffect level was 40-times the exposure at the MRHD. 
je bila pri podganah 40-kratnik izpostavljenosti med uporabo MRHD.
- Patients with recent or recurrent history of DKA (e.g.1 episode in the past 3 months or more than 
- z nedavno DKA ali anamnezo ponavljajočih se DKA (npr. 1 pojav v preteklih 3 mesecih ali več kot 1 pojav v preteklih 6 mesecih).
• DKA may occur in patients treated with sotagliflozin even if blood glucose levels are below 14 mmol/l (250 mg/dl), i.e. an explanation of the concept of euglycaemic DKA. 
• DKA se lahko pojavi pri bolnikih, ki se zdravijo s sotagliflozinom, tudi če je koncentracija glukoze v krvi pod 14 mmol/l (250 mg/dl), tj. razlaga koncepta evglikemične DKA.
In patients where DKA is suspected or diagnosed, treatment with sotagliflozin should be discontinued immediately. 
V primeru suma na DKA ali potrjene DKA je treba zdravljenje s sotagliflozinom takoj prekiniti.
Blood creatinine increased/Glomerular filtration decreased and renal-related events Sotagliflozin was associated with decreases in mean eGFR at week 4 (-4.0% and -4.3% for sotagliflozin 200 mg and 400 mg) versus placebo (-1.3%) that were generally reversible during continuous treatment. 
Zvišanje kreatinina v krvi/zmanjšanje glomerularne filtracije in z ledvicami povezani dogodki Sotagliflozin je bil povezan z zmanjšanjem povprečne eGFR po 4 tednih (-4,0 % z 200 mg sotagliflozina in -4,3 % s 400 mg sotagliflozina) v primerjavi s placebom (-1,3 %); ta zmanjšanja so bila med neprekinjenim zdravljenjem na splošno reverzibilna.
In addition to this leaflet, a patient alert card is included in the packaging which contains important safety information that you need before and during treatment with Zynquista. 
Kartica obsega pomembne informacije o varnosti, s katerimi morate biti seznanjeni pred zdravljenjem z zdravilom Zynquista in med takšnim zdravljenjem.
In InTandem1 (study 1) and in InTandem2 (study 2) sotagliflozin was used as add on to optimised insulin and in InTandem3 (Study 3) sotagliflozin was used as add on to any existing insulin regimen in patients not on HbA1c goal. 
V InTandem1 (študija 1) in v InTandem2 (študija 2) preskušanju, so sotagliflozin uporabili kot dodatek k optimalnemu zdravljenju z insulinom.
Treatment with sotagliflozin also resulted in reduction in body weight and systolic blood pressure (in patients with baselines SBP ≥130 mmHg) compared with insulin alone (see Table 6). 
Zdravljenje s sotagliflozinom je v primerjavi s samim insulinom povzročilo tudi zmanjšanje telesne mase in znižanje sistoličnega krvnega tlaka (pri bolnikih z izhodiščnim SKT ≥ 130 mmHg) (glejte preglednico 6).
The PK of sotagliflozin appeared to be dose proportional in the therapeutic dose range of 200 mg to 400 mg QD. 
Farmakokinetika sotagliflozina je bila v razponu terapevtskih odmerkov od 200 do 400 mg na dan sorazmerna odmerku.
Adverse reactions related to volume depletion (e.g., hypovolemia, blood pressure decreased, blood pressure systolic decreased, dehydration, hypotension, orthostatic hypotension, and syncope) were reported by 2.7%, 1.1% and 1.0% of patients treated with sotagliflozin 200mg, sotagliflozin 400 mg and placebo. 
O neželenih učinkih, povezanih s hipovolemijo (npr. pomanjkanje volumna, znižanje krvnega tlaka, znižanje sistoličnega krvnega tlaka, dehidracija, hipotenzija, ortostatska hipotenzija in sinkopa), so poročali pri 2,7 %, 1,1 % in 1,0 % bolnikov, ki so prejemali 200 mg sotagliflozina, 400 mg sotagliflozina in placebo.. Sotagliflozin lahko poveča tveganje za hipotenzijo pri bolnikih s tveganjem za zmanjšanje volumna (glejte poglavje 4.4).
Placebo (N=526) 
Insulin (N = 526)
No reduction in basal insulin is recommended when initiating sotagliflozin. 
Odmerek bazalnega insulina ob uvedbi sotagliflozina ni treba zmanjšati.
• Patients with euglycaemic DKA may need glucose in addition to standard of care for DKA and sotagliflozin should be discontinued if DKA occurs. 
• Bolniki z evglikemično DKA lahko poleg standardnega zdravljenja DKA potrebujejo tudi glukozo, zdravljenje s sotagliflozinom pa je treba prekiniti, če se pojavi DKA.
In subjects with renal impairment, exposure to sotagliflozin following a single dose of 400 mg was approximately 1.7 fold higher in subjects with mild and up to 2.7 fold higher in subjects with moderate renal impairment compared to subjects with normal renal function. 
Izpostavljenost sotagliflozinu je bila po enkratnem 400-mg odmerku pri preiskovancih z blago okvaro ledvic približno 1,7-krat večja in pri preiskovancih z zmerno okvaro ledvic približno 2,7-krat večja kot pri tistih z normalnim delovanjem ledvic.
While treated with Zynquista the risk of DKA is increased and may occur with low, normal or high blood glucose level. 
Med zdravljenjem z zdravilom Zynquista je tveganje za DKA večje; DKA se lahko pojavi ne glede na to, ali imate koncentracijo glukoze v krvi nizko, normalno ali visoko.
Based on a population PK analysis gender and race had no clinically meaningful effect on the PK of sotagliflozin. 
Na podlagi populacijske farmakokinetične analize spol in rasa ne vplivata klinično pomembno na farmakokinetiko sotagliflozina.
In the pooled 52-week data, the incidence of DKA was increased in a dose-dependent manner for sotagliflozin (2.9% and 3.8% for sotagliflozin 200 mg and 400 mg, respectively) compared to placebo (0.2%). 
Pojavnost DKA se je v združenih 52-tedenskih podatkih s sotagliflozinom povečevala od odmerka odvisno (2,9 % z 200 mg in 3,8 % s 400 mg sotagliflozina) v primerjavi s placebom (0,2 %).
• if you develop a combination of symptoms of pain, tenderness, redness, or swelling of the genitals or the area between the genitals and the anus with fever or feeling generally unwell. 
• če se vam pojavi kombinacija simptomov bolečin, občutljivosti, pordelosti ali oteklosti spolovil ali predela med splovili in zadnjikom (presredka) skupaj z zvišano telesno temperaturo ali splošnim slabim počutjem.
Ketone monitoring during treatment: 
Vodenje ketonov med zdravljenjem
How to take Zynquista 
Kako jemati zdravilo Zynquista
• Patient's/Carer's Guide 
• Vodnika za bolnike/skrbnike
Pooled analysis of change in SBP in patients with baseline SBP ≥130 mmHg showed greater reduction in SBP at week 12 (-5.4 mmHg for placebo, -9.0 mmHg for sotagliflozin 200 mg and -10.7 mmHg for sotagliflozin 400 mg). 
Združena analiza spremembe SKT pri bolnikih z izhodiščnim SKT ≥ 130 mmHg je pokazala večje znižanje SKT po 12 tednih (-5,4 mmHg s placebom, -9,0 mmHg z 200 mg sotagliflozina in -10,7 mmHg s 400 mg sotagliflozina).
Patients using an insulin infusion pump have a higher risk of DKA and should be experienced with pump use, common trouble-shooting strategies when interruptions of insulin delivery via pump occur (issues with insertion site, clogged tubing, empty reservoir, etc.) and use of supplemental insulin injections with pen or syringe as needed in case of pump failure. 
Imeti morajo izkušnje z uporabo črpalke, običajnimi načini odpravljanja težav v primeru prekinitve dovajanja insulina iz črpalke (težave na mestu vstavitve, zamašen kateter, prazen rezervoar itn.) ter z uporabo dodatnih injekcij insulina s peresnikom ali brizgo v primeru odpovedi črpalke.
Mean change from baseline at week 4 
Povprečna sprememba od izhodišča 4. teden
BMI is a measure of your weight in relation to your height.Type 1 diabetes is a disease where your body's immune system destroys the insulin-producing cells in the pancreas and the body produces little to no insulin, the hormone that normally controls the level of your blood sugar. 
Sladkorna bolezen tipa 1 je bolezen, pri kateri lastni imunski sistem telesa uniči celice, v katerih v trebušni slinavki nastaja insulin.
Sotagliflozin is not recommended in patients with moderate and severe hepatic impairment (see sections 4.4 and 5.2). 
Za bolnike z zmerno in hudo jetrno okvaro sotagliflozin ni priporočljiv (glejte poglavji 4.4 in 5.2).
Hypotension/ volume depletion 
Hipotenzija/hipovolemija
You should not take this medicine if you are breast-feeding. 
Če dojite, tega zdravila ne smete jemati.
In the study 52% were male and 96.2% were White and 87% of randomised patients completed the study. 
V kliničnem preskušanju je bilo 52 % moških in 96,2 % belcev; klinično preskušanje je dokončalo 87 % randomiziranih bolnikov.
Initiation of sotagliflozin is not recommended when eGFR is less than 60 ml/min/1.73 m2 and should be discontinued if eGFR is persistently less than 45 mL/min/1.73 m2 (see sections 4.4 and 4.8). 
Sotagliflozina ni priporočljivo uvesti, če je eGFR manj kot 60 ml/min in ga je potrebno ukiniti če je, če je eGFR manj kot 45 ml/min/1,73 m2 (glejte poglavje 4.2 in 4.8).
Mean change from baseline at week 52 
Povprečna sprememba od izhodišča 52. teden
Mean change from baseline at week 24 
Povprečna sprememba od izhodišča 24. teden
The exposure-adjusted incidence rate was 3.12, 4.19 and 0.21 subjects per 100 patient-years for sotagliflozin 200 mg, sotagliflozin 400 mg and placebo. 
Za izpostavljenost prilagojeni incidenčni deleži so bili 3,12, 4,19 in 0,21 preiskovanca na 100 bolnikov-let za 200 mg sotagliflozina, 400 mg sotagliflozina in placebo.
100 film-coated tablets 
Filmsko obložena tableta 100 filmsko obloženih tablet
Clinical stage 
KLINIČNI PODATKI
Be aware that either uro-genital infection or perineal abscess may precede necrotizing fasciitis. 
Vedeti morate, da se lahko pred nekrotizirajočim fascitisom pojavi urogenitalna okužba ali perinealni absces.
• dehydration (losing too much water from your body, symptoms include dry mouth, feeling dizzy, 
• dehidracija (prekomerna izguba vode iz telesa; med simptomi so suhost ust, omotica, vrtoglavica ali šibkost, zlasti ko vstanete, omedlevica)
- Printing ink: shellac; iron oxide black (E172); propylene glycol. 
- Barva za napis: šelak, črni železov oksid E172, propilenglikol.
* See section 4.4 † See subsections below for additional information. 
† Za dodatne informacije glejte podpoglavja spodaj.
In a pre-specified pooled analysis of study 1 and study 2, treatment with sotagliflozin as adjunct to insulin resulted in a reduction of SBP (-0.6 mmHg for placebo, -2.6 mmHg for sotagliflozin 200 mg and -4.1 mmHg for sotagliflozin 400 mg) at week 12. 
V vnaprej določeni združeni analizi podatkov študije 1 in študije 2 je zdravljenje s sotagliflozinom kot dodatkom insulinu po 12 tednih doseglo znižanje SKT (-0,6 mmHg s placebom, -2,6 mmHg z 200 mg sotagliflozina in -4,1 mmHg s 400 mg sotagliflozina).
This treatment is indicated as an adjunct to insulin therapy to improve glycaemic control in adults with T1DM with a BMI ≥27 kg/m2, who have failed to achieve adequate glycaemic control despite optimal insulin therapy. 
To zdravilo je indicirano kot dodatek zdravljenju z insulinom za izboljšanje urejenosti glikemije pri odraslih s sladkorno boleznijo tipa 1 in ITM ≥ 27 kg/m2, ki kljub optimalnemu zdravljenju z insulinom niso dosegli ustrezne urejenosti glikemije.
Zynquista 200 mg film-coated tablets (tablets) are oval, blue, with “2456” on one side printed in black ink (tablet length: 14.2 mm, tablet width: 8.7 mm). 
Filmsko obložene tablete (tablete) zdravila Zynquista 200 mg so ovalne oblike in modre barve ter imajo na eni strani s črnim črnilom natisnjeno oznako "2456" (dolžina tablete: 14,2 mm, širina tablete:
• if you have an infection of the kidney or the urinary tract. 
• če imate okužbo ledvic ali sečil.
Animal studies do not indicate direct or indirect harmful effects with respect to fertility and pregnancy (see section 5.3). 
Študije na živalih ne kažejo neposrednih ali posrednih škodljivih učinkov na plodnost in nosečnost
Frequency of occurrence Very common Common 
Pogostnost pojavljanja
Zynquista is indicated as an adjunct to insulin therapy to improve glycaemic control in adults with type 1 diabetes mellitus with a Body Mass Index (BMI) ≥ 27 kg/m2, who have failed to achieve adequate glycaemic control despite optimal insulin therapy. 
Zdravilo Zynquista je indicirano kot dodatek zdravljenju z insulinom za izboljšanje urejenosti glikemije pri odraslih s sladkorno boleznijo tipa 1 z indeksom telesne mase (BMI)) ≥ 27 kg/m2, ki kljub optimalnemu zdravljenju z insulinom ne dosegajo primerne urejenosti glikemije.
*Systolic blood pressure was assessed at week 16 † p <0.001 ‡ p=0.002 
*Sistolični krvni tlak so ocenili po 16 tednih
• Patients with euglycaemic DKA should receive glucose, insulin and fluids for DKA, sotagliflozin should be discontinued. 
• Bolniki z evglikemično DKA morajo prejemati glukozo, insulin in tekočine za DKA, zdravljenje s sotagliflozinom pa je treba prekiniti.
Study 3 InTandem 3 (study 3) was a 24-week duration study performed on a background of existing insulin regimen in type 1 diabetes patients with screening HbA1c ≥7.0% to ≤11.0%, to evaluate efficacy and safety of sotagliflozin 400 mg once daily versus insulin alone. 
Klinično preskušanje InTandem 3 (študija 3) je bila 24-tedenska študija, izvedena v okoliščinah obstoječe insulinske sheme pri bolnikih s sladkorno boleznijo tipa 1, ki so imeli ob presejanju HbA1c od ≥ 7,0 % do ≤ 11,0 %.
The incidence of renal-related events was low and similar across the groups (1.5%, 1.5% and 1.3% for sotagliflozin 200 mg, sotagliflozin 400 mg and placebo). 
Pojavnost z ledvicami povezanih dogodkov je bila majhna in med skupinami podobna (1,5 % z 200 mg sotagliflozina, 1,5 % s 400 mg sotagliflozina in 1,3 % s placebom).
Table 3: Changes from baseline in serum creatinine and eGFR in the pool of two 52-week placebocontrolled studies 
Preglednica 3: Spremembe kreatinina v serumu in eGFR od izhodišča; združeni podatki dveh
Treatment with sotagliflozin also resulted in reduction in body weight and bolus insulin dose compared with insulin alone (see Table 6). 
Zdravljenje s sotagliflozinom je v primerjavi s samim insulinom povzročilo tudi zmanjšanje telesne mase in odmerka bolusnega insulina (glejte preglednico 6).
Pharmacotherapeutic group: Drugs used in diabetes, sodium-glucose co-transporter 2 (SGLT2) inhibitors, ATC code: A10BK06 
Farmakoterapevtska skupina: zdravila za zdravljenje diabetesa, zaviralci od natrijevih ionov odvisnega glukoznega soprenašalca 2 (SGLT2).
Monitoring of renal function is recommended as follows: - Prior to initiation of sotagliflozin and monitored periodically, at least yearly, thereafter (see section 4.2). 
- Pred uvedbo sotagliflozina in nato redno vsaj enkrat na leto (glejte poglavje 4.2).
Check your ketones regularly during the first two weeks after starting Zynquista. 
Prva dva tedna po začetku jemanja zdravila Zynquista redno kontrolirajte ketone.
The risk of diabetic ketoacidosis must be considered in the event of non-specific symptoms such as nausea, vomiting, anorexia, abdominal pain, excessive thirst, difficulty breathing, confusion, unusual fatigue or sleepiness. 
Če se pojavijo nespecifični simptomi, kot so navzea, bruhanje, neješčnost, bolečine v trebuhu, prekomerna žeja, težko dihanje, zmedenost, neobičajna utrujenost ali zaspanost, je treba upoštevati možnost diabetične ketoacidoze.
• ZYNQUISTA should be temporarily stopped before surgical procedures or hospitalisation for acute serious illness. 
• Uporabo zdravila Zynquista je treba začasno prekiniti pred operacijami ali ob sprejemu v bolnišnico zaradi akutne resne bolezni.
The patient should go to emergency department without delay and stop taking sotagliflozin. 
Bolnik se mora nemudoma oglasiti v ambulanti za nujno medicinsko pomoč in prenehati jemati sotagliflozin.
o nausea, vomiting, or abdominal pain o excessive thirst o constantly feeling tired o high levels of ketones in urine tests or beta-hydroxybutyrate (BHB) in blood tests o difficulty breathing/rapid, deep breathing o breath with fruity odour o difficulty paying attention, or confusion o rapid weight loss. 
o visoka koncentracija ketonov v testih urina ali betahidroksibutirata (BHB) v krvi o težko dihanje/hitro, globoko dihanje, o sadni vonj izdihanega zraka o težave z zbranostjo ali zmedenost, o hitro hujšanje.
In a 12 week dose ranging study, consistent with SGLT1 inhibition, placebo corrected change from baseline 2-hour post prandial glucose (PPG), measured after a standardised mixed meal, was reduced by 1.52 mmol/L (p=0.15) and 2.73 mmol/L (p=0.006) in patients taking 200 mg and 400 mg sotagliflozin respectively, which is consistent with SGLT1 inhibition. 
Znižanje postprandialne glukoze V 12-tedenskem preskušanju odmerjanja se je (skladno z zavrtjem SGLT1) za placebom popravljena postprandialna glukoza (PPG) 2 uri po standardiziranem mešanem obroku v primerjavi z izhodiščem znižala za 1,52 mmol/l (p = 0,15) pri bolnikih, ki so prejemali 200 mg sotagliflozina in za 2,73 mmol/l (p = 0,006) pri bolnikih, ki so prejemali 400 mg sotagliflozina; kar je skladno z zaviranjem SGLT1.
Pharmacologically-related reversible renal changes were observed in a rat postnatal study, corresponding to the second and third trimesters of human pregnancy (see section 5.3). 
Pri podganah so v postnatalni študiji opazili farmakološko pogojene, reverzibilne ledvične spremembe med obdobjem, ki ustreza drugemu in tretjemu trimesečju nosečnosti pri človeku (glejte poglavje 5.3), zato sotagliflozin v drugem in tretjem trimesečju nosečnosti ni priporočljiv.
In a pre-/post-natal development study, no sotagliflozin-related adverse effects in pregnant and lactating females and offspring development were observed in rats In a study evaluating the potential effects of sotagliflozin on the development of juvenile rats, no sotagliflozin-related toxicity was observed following the administration of oral doses up to approximately 18 and 31 fold that of the MRHD (400 mg/day) for males and females, respectively. 
V študiji možnih učinkov sotagliflozina na razvoj mladih podgan niso opazili s sotagliflozinom povezanih toksičnih učinkov po uporabi peroralnih odmerkov, ki so bili pri samcih približno 18-krat in pri samicah približno 31-krat tolikšni kot MRHD (400 mg/dan).
From study 1 and study 2, 278 subjects participated in a blinded continuous glucose monitoring (CGM) sub-study (see Table 5). 
Podštudija stalnega spremljanja glukoze (CGM): 2-urna postprandialna glukoza in čas v območju 2.278 preiskovancev iz študije 1 in študije 2 je sodelovalo v podštudiji na slepo stalnega spremljanja glukoze (CGM - continuous glucose monitoring) (glejte preglednico 5).
Mean terminal T1/2 ranged from 21 to 35 hours for sotagliflozin and from 19 to 26 hours for M19. 
do 35 ur in M19 od 19 do 26 ur.
PVC/PCTFE/Aluminium opaque blisters. 
Motni pretisni omoti iz PVC/PCTFE/aluminija.
The HbA1c reduction observed in patients with eGFR ≥60 to <90 mL/min/1.73 m2 was comparable to the HbA1c reduction observed in patients with eGFR ≥90 mL/min/1.73 m2. 
HbA1c pri bolnikih z eGFR od ≥ 60 do < 90 in ≥ 90 ml/min/1,73 m2 je bilo primerljivo kot pri bolnikih z eGFR ≥ 90 ml/min/1,73 m2 Pri bolnikih z eGFR < 60 ml/min/1,73 m2 so opazili številsko zmanjšanje HbA1c.
At screening the HbA1c was 8.21%, 8.26% and 8.20% for insulin, insulin+sotagliflozin 200 mg and insulin+sotagliflozin 400 mg. 
Ob presejanju je bil HbA1c v skupini z insulinom 8,21%, v skupini z insulinom + 200 mg sotagliflozina 8,26% ter v skupini z insulinom + 400 mg sotagliflozina je bil HbA1c 8,20 %.
Due to the limited therapeutic experience in patients aged 75 years and older, initiation of sotagliflozin therapy is not recommended. 
75 let ali več, uvedba zdravljenja s sotagliflozinom v tej starostni skupini ni priporočljiva.