FrancophonIA/ELRC3.0 huggingface dataset:
English: In an add-on to metformin and a sulphonylurea study, up to 24 weeks, minor episodes of hypoglycaemia were reported in 12.8% of subjects who received dapagliflozin 10 mg plus metformin and a sulphonylurea and in 3.7% of subjects who received placebo plus metformin and a sulphonylurea.
Slovenian: V študiji dodatka metforminu in sulfonilsečnini, v obdobju do 24 tednov, so blage hipoglikemije zabeležili pri 12,8 % preiskovancev, ki so prejemali 10 mg dapagliflozina skupaj z metforminom in sulfonilsečnino, ter pri 3,7 % preiskovancev, ki so prejemali placebo skupaj z metforminom in sulfonilsečnino.
English: • The active substances are dapagliflozin and metformin hydrochloride (metformin HCl).
Slovenian: • Učinkovini sta dapagliflozin in metforminijev klorid.
English: In the dapagliflozin cardiovascular outcomes study with 17,160 type 2 diabetes mellitus patients and a median exposure time of 48 months, a total of 6 cases of Fournier's gangrene were reported, one in the dapagliflozin-treated group and 5 in the placebo group.
Slovenian: V študiji srčno-žilnih izidov z dapagliflozinom, v katero je bilo vključenih 17.160 bolnikov s sladkorno boleznijo tipa 2 in v kateri je bil mediani čas izpostavljenosti 48 mesecev, so skupno poročali o 6 primerih Fournierjeve gangrene: o 1 v skupini, zdravljeni z dapagliflozinom, in o 5 v skupini, ki je prejemala placebo.
English: Your doctor may consider temporarily changing your treatment if you develop a serious infection.
Slovenian: Če se vam pojavi resna okužba, vam bo zdravnik morda začasno spremenil zdravljenje.
English: Intravascular administration of iodinated contrast agents may lead to contrast induced nephropathy, resulting in metformin accumulation and increased risk of lactic acidosis.
Slovenian: Intravaskularna aplikacija jodiranih kontrastnih sredstev lahko povzroči nefropatijo zaradi kontrastnega sredstva, ki povzroči kopičenje metformina in povečano tveganje laktacidoze.
English: 10 tablets blister: {Sun/Moon symbol} 14 tablets blister: Mon. Tue. Wed. Thu. Fri. Sat. Sun. {Sun/Moon symbol}
Slovenian: Pretisni omot z 10 tabletami: {Simbol sonce/luna} Pretisni omot s 14 tabletami: Pon.
English: Metformin passes into human milk in small amounts.
Slovenian: Metformin v majhnih količinah prehaja v materino mleko.
English: Vulvovaginal pruritus Pruritus genital
Slovenian: Motnje reprodukcije in dojk vulvovaginalno srbenje srbenje spolovil
English: The proportion of subjects remaining in the study at Week 104 was 72.4% for the group treated with dapagliflozin 10 mg and 54.8% for the placebo group.
Slovenian: Delež preiskovancev, ki so 104. teden še ostali v študiji, je bil v skupini z 10 mg dapagliflozina 72,4 % in v skupini s placebom 54,8 %.
English: As an add-on therapy to metformin in an active-controlled non-inferiority study, dapagliflozin resulted in a statistically significant body weight change compared with glipizide of -4.65 kg at 52 weeks (p < 0.0001, Table 3) that was sustained at 104 and 208 weeks (-5.06 kg and -4.38 kg, respectively).
Slovenian: Dapagliflozin je kot dodatek zdravljenju z metforminom v študiji neinferiornosti, kontrolirani z učinkovino, v primerjavi z glipizidom povzročil statistično značilno spremembo telesne mase za -4,65 kg po 52 tednih (p < 0,0001, preglednica 3); znižanje se je 104. in 208. teden ohranilo (-5,06 kg po 104 in -4,38 kg po 208 tednih).
English: • Urinary tract infection, seen commonly (may affect up to 1 in 10 people).
Slovenian: • Okužba sečil, ki je pogosta (pojavi se lahko pri največ 1 od 10 bolnikov).
English: The secondary endpoints were a renal composite endpoint and all-cause mortality.
Slovenian: Sekundarna opazovana dogodka sta bila sestavljeni ledvični opazovani dogodek in umrljivost zaradi vseh vzrokov.
English: Improvement in homeostasis model assessment for beta cell function (HOMA beta-cell) has been observed in clinical studies with dapagliflozin.
Slovenian: V kliničnih študijah dapagliflozina so ugotovili izboljšanje homeostatske modelne ocene delovanja celic beta (HOMA celic beta).
English: This urinary glucose excretion with dapagliflozin also results in osmotic diuresis and increases in urinary volume in subjects with type 2 diabetes mellitus.
Slovenian: To izločanje glukoze z urinom z dapagliflozinom pri bolnikih s sladkorno boleznijo tipa 2 povzroči tudi osmotsko diurezo in povečanje količine urina.
English: Adverse reaction was identified through post-marketing surveillance with the use of dapagliflozin.
Slovenian: Neželeni učinek je bil ugotovljen med nadzorom v obdobju trženja dapagliflozina.
English: In subjects with mild or moderate hepatic impairment (Child-Pugh classes A and B), mean Cmax and AUC of dapagliflozin were up to 12% and 36% higher, respectively, compared with healthy matched control subjects.
Slovenian: Pri preiskovancih z blago ali zmerno okvaro jeter (Child-Pugh A in B) je bila Cmax dapagliflozina do 12 % večja, njegova AUC pa do 36 % večja kot pri ujemajočih se zdravih primerjalnih osebah.
English: The administration of this medicinal product in healthy volunteers after a high fat meal compared to after the fasted state resulted in the same extent of exposure for both dapagliflozin and metformin.
Slovenian: Pri zdravih prostovoljcih, ki so to zdravilo uporabili po zelo mastnem obroku, je bila izpostavljenost tako dapagliflozinu kot metforminu enaka kot po uporabi na tešče.
English: Placebo + insulin ± oral glucose-lowering medicinal products
Slovenian: Placebo + insulin ± peroralni antidiabetiki
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 zvišanja insulina, če je bilo potrebno) Vsi randomizirani preiskovanci, ki so prejeli vsaj en odmerek dvojno slepljenega raziskovanega zdravila med kratkoročnim dvojno slepim obdobjem Povprečje najmanjših kvadratov, korigirano 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 Zviševanje insulinskih shem (vključno s kratkodelujočim, srednjedolgodelujočim in bazalnim insulinom) je bilo dovoljeno le, če so bolniki izpolnjevali vnaprej določena merila glukoze v plazmi na tešče.
English: What Xigduo contains
Slovenian: Kaj vsebuje zdravilo Xigduo
English: Coadministration of multiple doses of dapagliflozin and metformin does not meaningfully alter the pharmacokinetics of either dapagliflozin or metformin in healthy subjects.
Slovenian: Pri zdravih preiskovancih sočasna uporaba večkratnih odmerkov dapagliflozina in metformina ne spremeni pomembno ne farmakokinetike dapagliflozina ne metformina.
English: In studies with dapagliflozin in add-on combination with metformin, minor episodes of hypoglycaemia were reported at similar frequencies in the group treated with dapagliflozin 10 mg plus metformin (6.9%) and in the placebo plus metformin group (5.5%).
Slovenian: V študijah dapagliflozina v kombinaciji z metforminom so bile blage hipoglikemije podobno pogoste v skupini, zdravljeni z 10 mg dapagliflozina skupaj z metforminom (6,9 %), kot v skupini, ki je prejemala placebo in metformin (5,5 %).
English: Inhibition of glucose and sodium co-transport by dapagliflozin is also associated with mild diuresis and transient natriuresis.
Slovenian: Zavrtje soprenosa glukoze in natrija z dapagliflozinom spremljata tudi blaga diureza in prehodna natriureza.
English: Xigduo must be discontinued prior to, or at the time of the imaging procedure and not restarted until at least 48 hours after, provided that renal function has been re-evaluated and found to be stable (see sections 4.2 and 4.4).
Slovenian: Zdravilo Xigduo je treba pred slikanjem ali v času slikanja ukiniti in se ga sme ponovno uvesti najmanj 48 ur pozneje, če je bilo delovanje ledvic ponovno ovrednoteno in ocenjeno kot stabilno, glejte poglavji 4.2 in 4.4.
English: BLISTERS (NON-PERFORATED)
Slovenian: PRETISNI OMOTI (NEPERFORIRANI)
English: Dapagliflozin 10 mg demonstrated non-inferiority versus placebo for the composite of cardiovascular death, myocardial infarction or ischaemic stroke (one-sided p < 0.001).
Slovenian: Dapagliflozin v odmerku 10 mg je bil v primerjavi s placebom neinferioren, kar zadeva sestavljeni dogodek srčno-žilne smrti, miokardnega infarkta ali ishemične možganske kapi (enostranska vrednost p < 0,001).
English: Reported in ≥ 2% of subjects and ≥ 1% more and at least 3 more subjects treated with dapagliflozin 10 mg compared to placebo.
Slovenian: Opisano pri ≥ 2 % preiskovancev ter pri ≥ 1 % več in pri vsaj 3 preiskovancih več med uporabo 10 mg dapagliflozina kot med uporabo placeba.
English: Urinary glucose excretion (glucuresis) induced by dapagliflozin is associated with caloric loss and reduction in weight.
Slovenian: Izločanje glukoze v urinu (glukureza) zaradi dapagliflozina je povezano z izgubo kalorij in zmanjšanjem telesne mase.
English: a) in an active-controlled study of dapagliflozin and metformin combination therapy in drug-naive patients
Slovenian: a) v študiji kombiniranega zdravljenja z dapagliflozinom in metforminom, kontrolirani z učinkovino, pri predhodno nezdravljenih bolnikih
English: In the separate dapagliflozin add-on to metformin pooled analysis, 623 subjects were treated with dapagliflozin 10 mg as add-on to metformin and 523 were treated with placebo plus metformin.
Slovenian: V ločeni kumulativni analizi dapagliflozina, dodanega metforminu, so 623 preiskovancev zdravili z 10 mg dapagliflozina, dodanega metforminu, 523 pa s kombinacijo placeba in metformina.
English: In subjects with severe hepatic impairment (Child-Pugh class C) mean Cmax and AUC of dapagliflozin were 40% and 67% higher than matched healthy controls, respectively.
Slovenian: Pri bolnikih s hudo okvaro jeter (Child-Pugh C) je bila povprečna Cmax dapagliflozina do 40 % večja in njegova AUC do 67 % večja kot pri ujemajočih se zdravih primerjalnih osebah.
English: Liver function disorders Hepatitis
Slovenian: Bolezni jeter, žolčnika in žolčevodov motnje delovanja jeter hepatitis
English: • Diabetic ketoacidosis, seen rarely (may affect up to 1 in 1,000 people) These are the signs of diabetic ketoacidosis (see also section 2 Warnings and precautions): - increased levels of “ketone bodies” in your urine or blood - rapid weight loss - feeling sick or being sick - stomach pain - excessive thirst - fast and deep breathing - confusion - unusual sleepiness or tiredness - a sweet smell to your breath, a sweet or metallic taste in your mouth or a different odour to your urine or sweat.
Slovenian: • Diabetična ketoacidoza, ki je redka (pojavi se lahko pri največ 1 od 1.000 bolnikov) Znaki diabetične ketoacidoze (glejte tudi 2. poglavje, Opozorila in previdnostni ukrepi) so: - zvišana raven "ketonskih teles" v urinu ali krvi - hitra izguba telesne mase - slabost ali bruhanje - bolečine v trebuhu
English: Xigduo has been demonstrated to be bioequivalent with coadministered dapagliflozin and metformin (see section 5.2).
Slovenian: Zdravilo Xigduo je dokazano bioekvivalentno s sočasno uporabljenima dapagliflozinom in metforminom (glejte poglavje 5.2).
English: NN:
Slovenian: SN: NN
English: No additional adverse reactions were identified for the dapagliflozin plus metformin group compared with those reported for the individual components.
Slovenian: V skupini, ki je prejemala kombinacijo dapagliflozina in metformina, niso ugotovili dodatnih neželenih učinkov poleg tistih, ki so bili opisani z vsakim posameznim od njiju.
English: No metabolites have been identified in humans.
Slovenian: Pri človeku niso ugotovili nobenih presnovkov.
English: Therefore, a lower dose of insulin or an insulin secretagogue may be required to reduce the risk of hypoglycaemia when used in combination with metformin (see sections 4.2 and 4.8)
Slovenian: Zato bo morda, za zmanjšanje tveganja za hipoglikemijo, potreben manjši odmerek insulina ali insulinskega sekretagoga, če je uporabljen v kombinaciji z metforminom (glejte poglavji 4.2 in 4.8).
English: Abbreviations: QD: once daily; BID: twice daily Metformin ≥ 1500 mg/day; Sitagliptin 100 mg/day LOCF: Last observation (prior to rescue for rescued subjects) carried forward Placebo-controlled 16-week study All randomised subjects who took at least one dose of double-blind study medicinal product during the short-term double-blind period Least squares mean adjusted for baseline value p-value < 0.0001 versus placebo + oral glucose-lowering medicinal product p-value < 0.05 versus placebo + oral glucose-lowering medicinal product The percent change in body weight was analysed as a key secondary endpoint (p < 0.0001); absolute body weight change (in kg) was analysed with a nominal p-value (p < 0.0001).
Slovenian: Metformin ≥ 1500 mg/dan, Sitagliptin 100 mg/dan LOCF: prenos zadnjega opažanja (pred rešilnim zdravljenjem za rešene preiskovance) [Last observation carried forward] S placebom kontrolirana 16-tedenska študija Vsi randomizirani preiskovanci, ki so prejeli vsaj en odmerek dvojno slepljenega raziskovanega zdravila med kratkoročnim dvojno slepim obdobjem Povprečje najmanjših kvadratov, korigirano za izhodiščno vrednost Vrednost p < 0,0001 v primerjavi s kombinacijo placebo + peroralni antidiabetik Vrednost p < 0,05 v primerjavi s kombinacijo placebo + peroralni antidiabetik Odstotek spremembe telesne mase so analizirali kot sekundarni opazovani dogodek (p < 0,0001); absolutno spremembo telesne mase (v kg) so analizirali z nominalno vrednostjo p (p < 0,0001).
English: Xigduo should be discontinued prior to, or at the time of, the imaging procedure and not restarted until at least 48 hours after, provided that renal function has been re-evaluated and found to be stable (see sections 4.2 and 4.5).
Slovenian: Zdravilo Xigduo je treba pred slikanjem ali v času slikanja ukiniti in se ga sme ponovno uvesti najmanj 48 ur pozneje, če je bilo delovanje ledvic ponovno ovrednoteno in ocenjeno kot stabilno, glejte poglavji 4.2 in 4.5.
English: Haematocrit increased Creatinine renal clearance decreased during initial treatment Dyslipidaemia
Slovenian: Preiskave zvišan hematokrit zmanjšan ledvični očistek kreatinina med uvodnim zdravljenjem dislipidemija zvišanje kreatinina v krvi med uvodnim zdravljenjem
English: In the placebo group there was an increase of 10.5 IU/day and 18.3 IU/day from baseline (mean average dose of 84 and 92 IU/day) at Weeks 48 and 104, respectively.
Slovenian: V skupini s placebom so 48. teden ugotovili povečanje za 10,5 i.e./dan (povprečni odmerek 84 i.e./dan) in 104. teden povečanje za 18,3 i.e./dan (povprečni odmerek 92 i.e./dan) v primerjavi z izhodiščem.
English: Treatment with dapagliflozin as an add-on to either metformin alone (dapagliflozin 10 mg QD or dapagliflozin 5 mg BID) or metformin plus sitagliptin, sulphonylurea or insulin resulted in statistically significant reductions in FPG (-1.90 to -1.20 mmol/L [-34.2 to -21.7 mg/dL]) compared with placebo (-0.58 to 0.18 mmol/L [-10.4 to 3.3 mg/dL]) at Week 16 (5 mg BID) or Week 24.
Slovenian: Zdravljenje z dapagliflozinom kot dodatkom bodisi metforminu samemu (dapagliflozin 10 mg enkrat na dan ali dapagliflozin 5 mg dvakrat na dan) bodisi metforminu v kombinaciji s sitagliptinom, sulfonilsečnino ali insulinom je statistično značilno znižalo glukozo v plazmi na tešče (-1,90 do -1,20 mmol/l [-34,2 do -21,7 mg/dl]) v primerjavi s placebom (-0,58 do 0,18 mmol/l [-10,4 do 3,3 mg/dl]) po 16 tednih (5 mg dvakrat na dan) ali 24 tednih.
English: Therefore, a lower dose of insulin or an insulin secretagogue may be required to reduce the risk of hypoglycaemia when used in combination with dapagliflozin (see sections 4.2 and 4.8).
Slovenian: Zato bo morda, za zmanjšanje tveganja za hipoglikemijo, potreben manjši odmerek insulina ali insulinskega sekretagoga, če je uporabljen v kombinaciji z dapagliflozinom (glejte poglavji 4.2 in 4.8).
English: Non-clinical data reveal no special hazard for humans based on conventional studies of repeated dose toxicity.
Slovenian: Predklinični podatki na osnovi običajnih študij toksičnosti pri ponavljajočih se odmerkih ne kažejo posebnega tveganja za človeka.
English: Urinary tract infection includes the following preferred terms, listed in order of frequency reported: urinary tract infection, cystitis, Escherichia urinary tract infection, genitourinary tract infection, pyelonephritis, trigonitis, urethritis, kidney infection and prostatitis.
Slovenian: Okužbe sečil obsegajo naslednje prednostne izraze, naštete v zaporedju opisanih pogostnosti: okužba sečil, cistitis, okužba sečil z Escherichio, okužba genitourinarnega trakta, pielonefritis, trigonitis, uretritis, okužba ledvic in prostatitis.
English: The pharmacokinetics of 5 mg dapagliflozin twice daily and 10 mg dapagliflozin once daily were compared in healthy subjects.
Slovenian: Farmakokinetiko 5 mg dapagliflozina dvakrat na dan in 10 mg dapagliflozina enkrat na dan so primerjali pri zdravih preiskovancih.
English: • Xigduo 5 mg/1,000 mg are 10.5 x 21.5 mm oval, yellow film-coated tablets.
Slovenian: • Zdravilo Xigduo 5 mg/1000 mg so 10,5 x 21,5 mm velike, ovalne, rumene filmsko obložene tablete.
English: In patients with eGFR < 60 mL/min/1.73 m2 at baseline, there were 19 events of serious adverse events suggestive of volume depletion in the dapagliflozin group and 13 events in the placebo group.
Slovenian: Med bolniki, ki so imeli izhodiščno eGFR < 60 ml/min/1,73 m2, je bilo v skupini z dapagliflozinom 19 primerov resnih neželenih učinkov, ki so nakazovali pomanjkanje volumna, v skupini s placebom pa 13.
English: In a pre-specified pooled analysis of 13 placebo-controlled studies, treatment with dapagliflozin 10 mg resulted in a systolic blood pressure change from baseline of -3.7 mmHg and diastolic blood pressure of -1.8 mmHg versus -0.5 mmHg systolic and -0.5 mmHg diastolic blood pressure for placebo group at Week 24.
Slovenian: V vnaprej opredeljeni kumulativni analizi 13 s placebom kontroliranih študij je zdravljenje z 10 mg dapagliflozina po 24 tednih spremenilo sistolični krvni tlak od izhodišča za -3,7 mmHg in diastolični krvni tlak za -1,8 mmHg v primerjavi z -0,5 mmHg za sistolični in -0,5 mmHg za diastolični krvni tlak v skupini s placebom.
English: Metformin stimulates intracellular glycogen synthesis by acting on glycogen synthase.
Slovenian: Metformin z delovanjem na glikogen-sintazo spodbuja znotrajcelično sintezo glikogena.
English: Maximum total daily dose is 10 mg.
Slovenian: Največji celotni dnevni odmerek je 10 mg.
English: Alcohol intoxication is associated with an increased risk of lactic acidosis, particularly in the case of fasting, malnutrition or hepatic impairment due to the metformin active substance of this medicinal product (see section 4.4).
Slovenian: Zaradi vsebnosti metformina v tem zdravilu spremlja akutno intoksikacijo z alkoholom večje tveganje za laktacidozo, zlasti v primeru postenja, podhranjenosti ali okvare jeter (glejte poglavje 4.4).
English: Combination therapy of dapagliflozin 10 mg and prolonged-release exenatide resulted in significantly greater reductions in 2-hour post-prandial glucose at Week 28 compared to either agent alone.
Slovenian: Pri kombiniranem zdravljenju z 10 mg dapagliflozina in eksenatidom v obliki s podaljšanim sproščanjem je bilo v 28. tednu doseženo značilno večje znižanje postprandialne glukoze po 2 urah kot pri kateri od obeh učinkovin samih.
English: Serious adverse events were reported in 81 (0.9%) and 70 (0.8%) in the dapagliflozin and placebo group, respectively.
Slovenian: O resnih neželenih učinkih so poročali pri 81 (0,9 %) bolnikih v skupini z dapagliflozinom in pri 70 (0,8 %) v skupini s placebom.
English: At Week 104 for insulin (with or without additional oral glucose-lowering medicinal products, including metformin), the HbA1c reductions were -0.71% and -0.06% adjusted mean change from baseline for dapagliflozin 10 mg and placebo, respectively.
Slovenian: 104. teden je bilo z insulinom (z dodatnim peroralnim antidiabetikom (vključno z metforminom) ali brez njega) znižanje HbA1c -0,71 % oziroma -0,06 % (korigirana povprečna sprememba z 10 mg dapagliflozina oziroma s placebom).
English: Treatment with dapagliflozin 10 mg plus metformin showed a numerical decrease in visceral adipose tissue compared with placebo plus metformin treatment in a magnetic resonance imaging substudy.
Slovenian: Pri zdravljenju s kombinacijo 10 mg dapagliflozina in metforminom se je v primerjavi s kombinacijo placeba in metformina v podštudiji z magnetnoresonančnim slikanjem pokazalo številsko zmanjšanje visceralnega maščevja.
English: Adverse reactions in dapagliflozin and metformin immediate-release clinical trial and post-marketing data
Slovenian: Neželeni učinki dapagliflozina in metformina s takojšnjim sproščanjem na podlagi kliničnih preskušanj in podatkov iz obdobja trženja Organski sistem
English: After an oral dose of metformin, tmax is reached in 2.5 h. Absolute bioavailability of a 500 mg or 850 mg metformin tablet is approximately 50-60% in healthy subjects.
Slovenian: Absolutna biološka uporabnost tablete 500 mg ali 850 mg metformina je pri zdravih preiskovancih približno 50-60 %.
English: In a separate analysis of subjects on insulin plus metformin, similar reductions in HbA1c to those seen in the total study population were seen in subjects treated with dapagliflozin with insulin plus metformin.
Slovenian: V ločeni analizi preiskovancev, ki so prejemali insulin in metformin, so pri preiskovancih, zdravljenih z dapagliflozinom v kombinaciji z insulinom in metforminom, ugotovili podobna znižanja HbA1c kot v celotni študijski populaciji.
English: Results of a 24-week placebo-controlled study of dapagliflozin in add-on combination with metformin and a sulphonylurea
Slovenian: Rezultati 24-tedenske, s placebom kontrolirane študije dapagliflozina v kombinaciji z dodatkom metformina in sulfonilsečnine Kombinacija z dodatkom Sulfonilsečnina + metformin
English: • nausea, vomiting
Slovenian: • slabost (siljenje na bruhanje), bruhanje
English: At Week 48 for metformin plus sitagliptin, the adjusted mean change from baseline for dapagliflozin 10 mg and placebo was -0.44% and 0.15%, respectively.
Slovenian: Po 48 tednih uporabe kombinacije metformina in sitagliptina je bila korigirana povprečna sprememba od izhodišča z 10 mg dapagliflozina -0,44 % in s placebom 0,15 %.
English: In a pre-specified analysis of subjects with baseline HbA1c ≥ 9.0%, treatment with dapagliflozin 10 mg resulted in statistically significant reductions in HbA1c at Week 24 as an add-on to metformin (adjusted mean change from baseline: -1.32% and -0.53% for dapagliflozin and placebo, respectively).
Slovenian: Vnaprej specificirana analiza preiskovancev z izhodiščnim HbA1c ≥ 9,0 % je pokazala, da je zdravljenje z 10 mg dapagliflozina kot dodatka metforminu do 24. tedna statistično značilno znižalo HbA1c (korigirana povprečna sprememba od izhodišča: dapagliflozin -1,32 % in placebo -0,53 %).
English: Nervous system disorders
Slovenian: Bolezni živčevja motnje okušanja omotica
English: Dapagliflozin did not induce tumours in either mice or rats at any of the doses evaluated in two-year carcinogenicity studies.
Slovenian: V dveletni študiji kancerogenosti ni dapagliflozin ne pri miših ne pri podganah sprožil nastanka tumorjev pri nobenem od ocenjevanih odmerkov.