FrancophonIA/ELRC3.0 huggingface dataset:
English: Your doctor may decide to temporarily or permanently stop your treatment with Edistride.
Slovenian: Zdravnik se bo morda odločil, da vam zdravljenje z zdravilom Edistride začasno prekine ali trajno konča.
English: All randomised patients who took at least one dose of double-blind study medication during the short-term double-blind period.
Slovenian: Vsi randomizirani bolniki, ki so prejeli vsaj en odmerek dvojno slepljenega raziskovanega zdravila med kratkoročnim dvojno slepim obdobjem.
English: • increases in the amount of red blood cells in your blood (shown in tests)
Slovenian: • povečanje števila rdečih krvnih celic v vaši krvi (to se pokaže v preiskavah)
English: • The risk of developing diabetic ketoacidosis may be increased with prolonged fasting, excessive alcohol consumption, dehydration, sudden reductions in insulin dose, or a higher need of insulin due to major surgery or serious illness.
Slovenian: • tveganje za nastanek diabetične ketoacidoze je lahko večje v primeru dolgotrajnejšega stradanja, prekomernega uživanja alkoholnih pijač, dehidracije, nenadnega zmanjšanja odmerka insulina ali povečane potrebe po insulinu zaradi večje operacije ali resne bolezni.
English: Use in patients at risk for volume depletion and/or hypotension Due to its mechanism of action, dapagliflozin increases diuresis which may lead to the modest decrease in blood pressure observed in clinical studies (see section 5.1).
Slovenian: Uporaba pri bolnikih s tveganjem za zmanjšanje volumna in/ali hipotenzijo Dapagliflozin, zaradi mehanizma delovanja, poveča diurezo; to lahko povzroči zmerno znižanje krvnega tlaka, opaženo v kliničnih študijah (glejte poglavje 5.1).
English: The guide for healthcare professionals including the prescriber's checklist should contain the following key elements:
Slovenian: Vodnik za zdravstvene delavce, vključno s kontrolnim seznamom za zdravnike, ki prepisujejo zdravilo, mora vsebovati naslednje ključne elemente:
English: Edistride has not been studied in severe renal impairment (GFR < 30 mL/min) or end-stage renal disease (ESRD).
Slovenian: Zdravilo Edistride ni bilo raziskano pri hudi okvari ledvic (GFR < 30 ml/min) ali pri končni odpovedi ledvic (ESRD - end-stage renal disease).
English: • Your doctor will tell you when you may need to measure ketones in your blood or urine and what you need to do when your ketone levels are raised: - At blood ketone readings from 0.6 to 1.5 mmol/L (or urine ketones reading +) you may need to take extra insulin, drink water, and if your blood glucose is normal or low, you may need to eat carbohydrates.
Slovenian: • Zdravnik vam bo povedal, kdaj si boste morda morali izmeriti ketone v krvi ali urinu in kako boste morali ukrepati, če se vam koncentracija ketonov zviša: - Če je koncentracija ketonov v krvi od 0,6 do 1,5 mmol/l (ali če je rezultat testiranja ketonov v urinu +), boste morda morali uporabiti dodaten insulin in piti vodo; če imate normalen ali nizek krvni sladkor, boste morda morali zaužiti ogljikove hidrate.
English: The same recommendations for renal function apply to elderly patients as to all patients (see sections 4.2, 4.4, 4.8 and 5.1).
Slovenian: Za starejše bolnike veljajo enaka priporočila glede delovanja ledvic kot za ostale bolnike (glejte poglavja 4.2, 4.4, 4.8 in
English: Type 1 diabetes mellitus Treatment with Edistride is to be initiated and supervised by specialists in type 1 diabetes.
Slovenian: Sladkorna bolezen tipa 1 Zdravljenje z zdravilom Edistride morajo uvesti in nadzorovati specialisti za sladkorno bolezen tipa 1.
English: Patients who may be at higher risk of DKA include patients with a low beta-cell function reserve (e.g. type 1 diabetes patients, type 2 diabetes patients with low C-peptide or latent autoimmune diabetes in adults (LADA) or patients with a history of pancreatitis), patients with conditions that lead to restricted food intake or severe dehydration, patients for whom insulin doses are reduced and patients with increased insulin requirements due to acute medical illness, surgery or alcohol abuse.
Slovenian: Med bolniki, ki imajo lahko večje tveganje za DKA, so bolniki z majhno funkcijsko rezervo celic beta (npr. bolniki s sladkorno boleznijo tipa 1, bolniki s sladkorno boleznijo tipa 2 z nizkim C-peptidom ali latentno avtoimunsko sladkorno boleznijo odraslih (LADA-latent autoimmune diabetes in adults) ali bolniki po prebolelem pankreatitisu), bolniki z boleznimi, ki zmanjšajo uživanje hrane ali povzročijo hudo dehidracijo, bolniki po zmanjšanju odmerka insulina in bolniki, ki imajo povečano potrebo po insulinu zaradi akutnih internističnih bolezni, operacije ali zlorabe alkohola.
English: • It is recommended that patients obtain several baseline ketone levels over one to two weeks prior to initiation of dapagliflozin therapy, and patients should become familiar with how their behaviours and circumstances affect their ketone levels.
Slovenian: • Priporočljivo je, da bolniki v enem do dveh tednih pred uvedbo zdravljenja z dapagliflozinom večkrat izmerijo izhodiščne koncentracije ketonov; seznaniti se morajo tudi s tem, kako njihovo vedenje in okoliščine vplivajo na koncentracijo ketonov.
English: Frequency of adverse reaction was identified from the full study population in 2 placebo-controlled studies in subjects with type 1 diabetes mellitus.
Slovenian: Pogostnost neželenih učinkov je bila ugotovljena na podlagi celotne raziskovane populacije v 2 s placebom kontroliranih študijah pri preiskovancih s sladkorno boleznijo tipa 1.
English: Your doctor may prescribe Edistride together with other medicine(s) to lower the amount of sugar in your blood.
Slovenian: Zdravnik vam lahko zdravilo Edistride predpiše skupaj s kakšnimi drugimi zdravili za zmanjšanje količine sladkorja v vaši krvi.
English: • Counsel the patient and evaluate their adherence to ketone monitoring while establishing their baseline ketone level 1 to 2 weeks before treatment initiation and ensure the patient: o Has received education/training in ketone testing, and interpreting/acting upon test results o Is willing/able to perform ketone testing as prescribed o Is adequately informed about managing sick days
Slovenian: • Svetujte bolnikom in ocenite njihovo adherenco spremljanja ketonov med ugotavljanjem njihove izhodiščne koncentracije ketonov 1 do 2 tedna pred uvedbo zdravljenja, in poskrbite, da je bolnik: o prejel ustrezno izobraževanje/usposabljanje glede testiranja ketonov, tolmačenja rezultatov testiranja in ukrepanja na podlagi teh rezultatov.
English: • Patient not on optimal insulin dose or who have recent issues with noncompliance or recurrent errors with insulin dosing and who are unlikely to maintain adequate insulin dosing.
Slovenian: • Bolniki, ki ne prejemajo optimalnega odmerka insulina, ali so imeli pred kratkim težave z nesodelovalnostjo, ponavljajo napake pri odmerjanju insulina, oz. pri katerih ni verjetno, da bodo insulin odmerjali ustrezno.
English: In patients with type 1 diabetes mellitus and a known risk of frequent or severe hypoglycaemia, it may be necessary to reduce the insulin dose at the time of initiating treatment with dapagliflozin to decrease the risk of hypoglycaemia.
Slovenian: Pri bolnikih s sladkorno boleznijo tipa 1 in znanim tveganjem za pogoste ali hude hipoglikemije je lahko ob uvedbi zdravljenja z dapagliflozinom potrebno zmanjšanje odmerka insulina, da bi zmanjšali tveganje za hipoglikemije.
English: Supplemental carbohydrate may be required in addition to hydration and additional rapid insulin (see Table 1 in section 4.2).
Slovenian: Poleg hidracije in dodatnega hitrodelujočega insulina so lahko potrebni dodatni ogljikovi hidrati (glejte preglednico 1 v poglavju 4.2).
English: • Guidance to the physician for assessing whether the patient is eligible for dapagliflozin prescription, e.g. patient selection criteria including adherence to insulin treatment and insulin thresholds, patient's beta-hydroxybutyrate (BHB) < 0.6 mmol/L or urine ketones < 1+, BMI ≥ 27 kg/m2, absence of DKA risk factors.
Slovenian: • Navodila zdravniku za oceno, ali je bolnik primeren za predpisovanje dapagliflozina, npr. merila za izbiro bolnikov, vključno z adherenco insulinskega zdravljenja in pragovi insulina, bolnikovo koncentracijo beta-hidroksibutirata (BHB) < 0,6 mmol/l ali ketoni v urinu < 1+, ITM ≥ 27 kg/m2, odsotnost dejavnikov tveganja za DKA.
English: • The patient should be informed how to recognize the risk factors which can predispose to ketosis (including starvation ketosis) and DKA and how to recognize DKA signs or symptoms.
Slovenian: • Bolnike je treba poučiti, kako prepoznajo dejavnike tveganja, ki lahko povečajo nagnjenost h ketozi (vključno s ketozo zaradi stradanja), kako prepoznajo DKA in kako prepoznajo znake in simptome DKA.
English: Patients should be informed about what actions to take if ketone levels are elevated.
Slovenian: Bolnike je treba seznaniti, kako naj ukrepajo, če je koncentracija ketonov zvišana.
English: The most frequently reported adverse reactions across the clinical studies were genital infections.
Slovenian: Najpogosteje zabeleženi neželeni učinki v kliničnih študijah so bile okužbe spolovil.
English: The most frequently reported adverse reactions associated with dapagliflozin in patients with type 1 diabetes mellitus were genital infections, which were more frequent in females.
Slovenian: Najpogosteje zabeleženi z dapagliflozinom povezani neželeni učinki pri bolnikih s sladkorno boleznijo tipa 1 so bile okužbe spolnih organov, ki so bile pri ženskah pogostejše.
English: • Ensure the patient is on optimal insulin therapy prior to initiation of dapagliflozin treatment.
Slovenian: • Zagotovite, da je bolnik pred uvedbo dapagliflozina na optimalnem insulinskem zdravljenju.
English: • necrotising fasciitis of the perineum or Fournier's gangrene, a serious soft tissue infection of the genitals or the area between the genitals and the anus, seen very rarely.
Slovenian: • nekrotizirajoči fasciitis presredka ali Fournierjeva gangrena, resna okužba mehkega tkiva spolovil ali predela med spolovili in zadnjikom, ki je zelo redka.
English: Edistride should only be used in type 1 diabetes patients who are overweight or obese.
Slovenian: Zdravilo Edistride se sme uporabljati le pri bolnikih s sladkorno boleznijo tipa 1, ki so pretežki ali debeli.
English: Very rare
Slovenian: Zelo pogosti
English: Subsequent bolus doses should be adjusted individually based on blood glucose results.
Slovenian: Naslednje bolusne odmerke je treba prilagoditi individualno glede na rezultate glukoze v krvi.
English: • Patients with elevated ketones levels (BHB reading is greater than 0.6 mmol/L or urine ketones one plus (+)).
Slovenian: • Bolniki z zvišano koncentracijo ketonov (izvid BHB več kot 0,6 mmol/l ali ketoni v urinu en križ (+)).
English: Hypoglycaemia The frequency of hypoglycaemia depended on the type of background therapy used in each study.
Slovenian: Hipoglikemija Pogostost pojavljanja hipoglikemij je bila odvisna od vrste osnovnega zdravljenja v posamezni študiji.
English: If any of the above applies to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking Edistride.
Slovenian: Če kaj od naštetega velja za vas (ali če ste negotovi), se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, preden vzamete zdravilo Edistride.
English: Edistride has no or negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo Edistride nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: Prior to launch of the new adult indication for dapagliflozin, for the treatment of insufficiently controlled type 1 diabetes mellitus as an adjunct to insulin in patients with BMI ≥ 27 kg/m2, when insulin alone does not provide adequate glycaemic control despite optimal insulin therapy, in each Member State, the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational materials, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Slovenian: Pred uvedbo nove indikacije za dapagliflozin pri odraslih za zdravljenje neustrezno urejene sladkorne bolezni tipa 1 kot dodatek insulinu pri bolnikih z ITM ≥ 27 kg/m2, če insulin sam ne zagotavlja ustrezne urejenosti glikemije kljub optimalnemu insulinskemu zdravljenju, se mora imetnik dovoljenja za promet z zdravilom (MAH) v vsaki državi članici s pristojnim nacionalnim organom dogovoriti glede vsebine in oblike izobraževalnih gradiv, vključno s sredstvi obveščanja, načini razdeljevanja in morebitnimi drugimi vidiki programa.
English: 8,582 patients were randomised to dapagliflozin 10 mg and 8,578 to placebo, and were followed for a median of 4.2 years.
Slovenian: 8582 bolnikov je bilo randomiziranih na 10 mg dapagliflozina in 8578 na placebo; bolnike so spremljali mediano 4,2 leta.
English: Edistride contains lactose (milk sugar).
Slovenian: Zdravilo Edistride vsebuje laktozo (mlečni sladkor).
English: • Patients who insist on maintaining caloric restriction, carbohydrate restriction or ketogenic diet or who chronically under-dose insulin (e.g. in order to remain in a lipolytic state).
Slovenian: • Bolniki, ki vztrajajo na uživanju kalorično omejene prehrane, prehrane z omejitvijo ogljikovih hidratov ali ketogene prehrane, in bolniki, ki insulin kronično odmerjajo prenizko (npr. za vzdrževanje lipolitičnega stanja).
English: In total, there were 30,623 patient-years of exposure to dapagliflozin.
Slovenian: V celoti je bila izpostavljenost dapagliflozinu 30623 bolnik-let.
English: In active- and placebo-controlled clinical studies (dapagliflozin, N=5936, All control, N=3403), the frequency of rash was similar for dapagliflozin (1.4%) and all control (1.4%), respectively.
Slovenian: V kliničnih študijah, kontroliranih z učinkovino in s placebom (dapagliflozin; n = 5936, vse kontrolne osebe; n = 3403) je bila pogostnost izpuščaja z dapagliflozinom (1,4 %) podobna kot pri vseh kontrolnih osebah
English: • Patients should be informed, in a dedicated education session, on the risk of DKA, how to recognize DKA risk factors, signs or symptoms, how and when to monitor ketone levels and what actions to take at elevated ketone readings (see section 4.4).
Slovenian: • Bolnike je treba na namenskem izobraževalnem srečanju seznaniti s tveganjem za DKA, prepoznavo dejavnikov tveganja za DKA ter njenih znakov in simptomov, kako in kdaj kontrolirati koncentracijo ketonov in kako ukrepati, če je koncentracija ketonov zvišana (glejte poglavje 4.4).
English: Edistride works by removing excess sugar from your body via your urine.
Slovenian: Zdravilo Edistride deluje tako, da odstranjuje odvečni sladkor iz vašega telesa z urinom.
English: In the two placebo-controlled clinical studies of dapagliflozin in type 1 diabetes mellitus, patients were advised to monitor blood ketones in case of suspected symptoms of DKA and seek medical advice/attention if their self-measured blood ketone reading was ≥ 0.6 mmol/L.
Slovenian: V dveh s placebom kontroliranih kliničnih študijah dapagliflozina pri sladkorni bolezni tipa 1 so bolnikom naročili, naj v primeru simptomov, sumljivih za DKA, kontrolirajo ketone v krvi in naj poiščejo zdravniški nasvet/pomoč, če je samoizmerjena vrednost ketonov v krvi ≥ 0,6 mmol/l.
English: - in type 1 diabetes the risk is higher - this is because your body hardly produces any insulin, and diabetic ketoacidosis may occur at sudden decreases in insulin dose (such as missed insulin injections, or issues with your insulin pen or pump).
Slovenian: - pri sladkorni bolezni tipa 1 je to tveganje večje - v telesu namreč ne nastaja skoraj nič insulina in diabetična ketoacidoza se lahko pojavi v primeru nenadnega zmanjšanja odmerka insulina (npr. izpuščenih injekcij insulina ali težav z insulinskim peresnikom ali insulinsko črpalko).
English: Dapagliflozin Effect on Cardiovascular Events (DECLARE) was an international, multicentre, randomised, double-blind, placebo-controlled clinical study conducted to determine the effect of dapagliflozin compared with placebo on cardiovascular outcomes when added to current background therapy.
Slovenian: Študija DECLARE (Dapagliflozin Effect on Cardiovascular Events) je bila mednarodna, multicentrična, randomizirana, dvojno slepa, s placebom nadzorovana klinična študija za ugotavljanje vpliva dapagliflozina v primerjavi s placebom na srčno-žilne izide med uporabo kot dodatka trenutnemu osnovnemu zdravljenju.
English: • The risk of DKA is increased with dapagliflozin treatment.
Slovenian: • Tveganje za DKA se med zdravljenjem z dapagliflozinom poveča.
English: • In the event of a marked reduction of insulin need, discontinuation of dapagliflozin should be considered.
Slovenian: • V primeru izrazitega zmanjšanja potrebe po insulinu je treba razmisliti o prenehanju uporabe dapagliflozina.
English: • increases in creatinine (shown in laboratory blood tests) in the beginning of treatment
Slovenian: • zvišanje kreatinina (to se pokaže v laboratorijskih preiskavah krvi) na začetku zdravljenja
English: Renal function and risk of volume depletion should be taken into account (see sections 4.4 and 5.2).
Slovenian: Treba je upoštevati delovanje ledvic in tveganje za zmanjšanje volumna (glejte poglavji 4.4 in 5.2).
English: • if you are allergic to dapagliflozin or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne jemljite zdravila Edistride: • če ste alergični na dapagliflozin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: There is limited experience in clinical studies in patients with hepatic impairment.
Slovenian: Izkušenj iz kliničnih študij pri bolnikih z okvaro jeter je malo.
English: p < 0.0001 versus placebo
Slovenian: p < 0,0001 v primerjavi z placebom.
English: The mean total systemic clearance of dapagliflozin administered intravenously was 207 mL/min.
Slovenian: Povprečni skupni sistemski očistek dapagliflozina, danega intravensko, je bil 207 ml/min.
English: Obligation to conduct post-authorisation measures: The MAH shall complete, within the stated timeframe, the below measures: Description
Slovenian: Obveznost za izvedbo ukrepov po pridobitvi dovoljenja za promet: Imetnik dovoljenja za promet z zdravilom mora v določenem časovnem okviru izvesti naslednje ukrepe:
English: • low blood sugar levels (hypoglycaemia) - when taking this medicine with a sulphonylurea or insulin
Slovenian: • nizek krvni sladkor (hipoglikemija) - če jemljete to zdravilo skupaj s kakšnim sulfonilsečninskim zdravilom ali insulinom.
English: LOCF: Last observation (prior to or on the date of the first insulin up-titration, if needed) carried forward All randomised subjects who took at least one dose of double-blind study medicinal product during the shortterm double-blind period Least squares mean adjusted for baseline value and presence of oral glucose-lowering medicinal product p-value < 0.0001 versus placebo + insulin ± oral glucose-lowering medicinal product p-value < 0.05 versus placebo + insulin ± oral glucose-lowering medicinal product Up-titration of insulin regimens (including short-acting, intermediate, and basal insulin) was only allowed if subjects met pre-defined FPG criteria.
Slovenian: LOCF: Prenos zadnjega opažanja (pred ali na datum prvega povečanja odmerka insulina, če je bilo potrebno) [Last observation carried forward] Vsi randomizirani preiskovanci, ki so vzeli vsaj en odmerek dvojno slepljenega raziskovanega zdravila med kratkoročnim dvojno slepim obdobjem Povprečje najmanjših kvadratov, prilagojeno za izhodiščno vrednost in prisotnost peroralnega antidiabetika Vrednost p < 0,0001 v primerjavi s kombinacijo placeba + insulina ± peroralnega antidiabetika Vrednost p < 0,05 v primerjavi s kombinacijo placeba + insulina ± peroralnega antidiabetika Povečevanje insulinske sheme (vključno s kratkodelujočim, srednjedolgodelujočim in bazalnim insulinom) je bilo dovoljeno le, če so bolniki izpolnjevali vnaprej določena merila glede glukoze v plazmi na tešče.
English: Restarting SGLT2 inhibitor treatment in patients experiencing a DKA while on SGLT2 inhibitor treatment is not recommended, unless another clear precipitating factor is identified and resolved.
Slovenian: Bolnikom, ki so kdaj imeli DKA med zdravljenjem z zaviralcem SGLT2, zaviralca SGLT2 ni priporočljivo znova uvesti, razen če je ugotovljen in odpravljen kakšen drug nedvomen sprožilni dejavnik.
English: Patients using a pump should also check their ketone levels with any suspected insulin interruption, regardless of blood glucose levels.
Slovenian: Bolniki, ki uporabljajo črpalko, morajo koncentracijo ketonov kontrolirati tudi pri vsakem sumu na prekinjeno dovajanje insulina, ne glede na koncentracijo glukoze v krvi.
English: At 24 weeks, reductions in serum uric acid concentrations ranged from -48.3 to -18.3 micromoles/L (-0.87 to -0.33 mg/dL).
Slovenian: Po 24 tednih je zmanjšanje koncentracije sečne kisline v serumu segalo od -48,3 do -18,3 do mikromolov/l (-0,87 do -0,33 mg/dl).
English: • If addition of dapagliflozin leads to marked reduction of insulin need, discontinuation of dapagliflozin should be considered to avoid high risk of DKA.
Slovenian: • Če dodatek dapagliflozina povzroči izrazito zmanjšanje potrebe po insulinu, je treba razmisliti o prenehanju uporabe dapagliflozina, da bi se izognili velikemu tveganju za DKA.
English: The patient should immediately seek medical advice and stop taking dapagliflozin if levels persist and symptoms present.
Slovenian: Bolnik mora nemudoma poiskati zdravniški nasvet in prenehati jemati dapagliflozin, če koncentracija traja in so prisotni simptomi.
English: Subsequently, basal insulin should be adjusted based on blood glucose results.
Slovenian: Pozneje je treba bazalni insulin prilagajati glede na rezultate glukoze v krvi.
English: Ketones should be monitored on a regular basis during the initial one to two weeks, then the frequency of ketone level testing should be individualised, according to the patient's lifestyle and/or risk factors (see section 4.2).
Slovenian: Ketone je treba redno kontrolirati v uvodnem tednu ali dveh, potem je treba pogostnost kontrol koncentracije ketonov prilagoditi individualno, glede na bolnikov življenjski slog in/ali dejavnike tveganja (glejte poglavje 4.2).
English: • Edistride is used if your type 1 diabetes cannot be controlled with insulin alone.
Slovenian: • Zdravilo Edistride se uporablja, če sladkorne bolezni tipa 1 ni mogoče urediti samo z insulinom.
English: Caution should be exercised in patients for whom a dapagliflozin-induced drop in blood pressure could pose a risk, such as patients on anti-hypertensive therapy with a history of hypotension or elderly patients.
Slovenian: Previdnost je potrebna pri bolnikih, pri katerih bi z dapagliflozinom povzročen padec krvnega tlaka lahko pomenil tveganje, npr. bolnikih, ki se zdravijo z antihipertenzivi in imajo hipotenzijo v anamnezi ali pri starejših bolnikih.
English: Your doctor may ask you to stop taking Edistride.
Slovenian: Zdravnik vam lahko svetuje, da prenehate z jemanjem zdravila Edistride.
English: Diabetic ketoacidosis b,i,k
Slovenian: zmanjšanje volumna b,e žeja diabetična ketocidoza b,i,k
English: These are signs of angioedema: - swelling of the face, tongue or throat - difficulties swallowing - hives and breathing problems
Slovenian: Znaki angioedema so: - oteklost obraza, jezika ali žrela - težave s požiranjem - koprivnica in težave z dihanjem.
English: The primary assessment of safety and tolerability was conducted in a pre-specified pooled analysis of 13 short-term (up to 24 weeks) placebo-controlled studies with 2,360 subjects treated with dapagliflozin 10 mg and 2,295 treated with placebo.
Slovenian: Primarno oceno varnosti in prenašanja so izvedli v vnaprej specificirani kumulativni analizi 13 kratkotrajnih (do 24 tednov trajajočih), s placebom nadzorovanih študij, v katere je bilo vključenih 2360 preiskovancev, ki so prejemali 10 mg dapagliflozina, in 2295 preiskovancev, ki so prejemali placebo.