natgillin/translations-raw huggingface dataset:
If acidosis of either form occurs, treatment must be stopped immediately and other appropriate corrective measures initiated. 
je treba zdravljenje nemudoma prekiniti in uvesti ustrezne korektivne ukrepe.
The mean Vd ranged between 63-276 l. 
Povprečni Vd je bil med 63 in
• Low blood sugar levels (hypoglycaemia), seen very commonly (may affect more than 1 in 10 people) - when taking this medicine with a sulphonylurea or other medicines that lower the amount of sugar in your blood, such as insulin. 
• Nizka koncentracija krvnega sladkorja (hipoglikemija), pojavi se zelo pogosto (pojavi se lahko pri več kot 1 od 10 bolnikov) - če jemljete to zdravilo skupaj s sulfonilsečnino ali drugimi zdravili,
− film-coating: polyvinyl alcohol (E1203), macrogol 3350 (E1520(iii)), talc (E553b), titanium dioxide (E171), iron oxides (E172). 
− filmska obloga: polivinilalkohol (E1203), makrogol 3350 (E1520(iii)), smukec (E553b), titanov dioksid (E171), železovi oksidi (E172).
Race There were no clinically relevant differences in systemic exposures between White, Black or Asian races. 
Sistemska izpostavljenost se med belsko, črnsko in azijsko raso ni klinično pomembno razlikovala.
The intravascular administration of iodinated contrast agents in radiological studies can lead to renal failure. 
Intravaskularna uporaba jodiranih kontrastnih sredstev pri radioloških preiskavah lahko povzroči odpoved ledvic.
MARKETING AUTHORISATION NUMBER(S) EU/1/13/900/012 
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/13/900/012
The intravascular administration of iodinated contrast agents in radiological studies may lead to renal failure, resulting in metformin accumulation and a risk of lactic acidosis. 
Intravaskularna uporaba jodiranih kontrastnih sredstev pri radioloških preiskavah lahko povzroči odpoved ledvic ter s tem kopičenje metformina in tveganje za laktacidozo.
In a study with add-on insulin therapy, higher rates of hypoglycaemia were observed (see section 4.5). 
V študiji z dodatkom insulinskemu zdravljenju so opažali večje deleže hipoglikemij (glejte poglavje 4.5).
Other medicines and Xigduo Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. 
Obvestite zdravnika, farmacevta ali medicinsko sestro, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
Primary episodes occurred at a rate of 1.62% per patient-year in subjects treated with dapagliflozin and 2.06% in comparator-treatment subjects, per patient-year. 
Delež primarnih dogodkov je bil pri prejemnikih dapagliflozina 1,62 % na bolnik-leto in pri prejemnikih primerjalnega zdravila 2,06 % na bolnik-leto.
Dapagliflozin or metformin have no or negligible influence on the ability to drive and use machines. 
4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Dapagliflozin in metformin nimata vpliva ali imata le zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
Lactic acidosis is characterised by acidotic dyspnoea, abdominal pain and hypothermia followed by coma. 
Za laktacidozo so značilne acidotična dispneja, bolečine v trebuhu in hipotermija, ki jim sledi koma.
Liver function disorders§ Hepatitis§ 
žolčnika in žolčevodov motnje delovanja jeter§ hepatitis§
Combinations not recommended 
Neraziskane kombinacije
Experience in NYHA class I-II is limited, and there is no experience in clinical studies with dapagliflozin in NYHA class III-IV. 
Srčno popuščanje Izkušenj v razredih I in II po NYHA je malo, izkušenj iz kliničnih študij dapagliflozina v razredih III in IV
The risk of lactic acidosis must be considered in the event of non-specific signs such as muscle cramps with digestive disorders, abdominal pain and severe asthenia. 
Na možnost laktacidoze je treba pomisliti v primeru nespecifičnih znakov, npr. mišičnih krčev s prebavnimi motnjami, bolečinami v trebuhu in hudo astenijo.
MARKETING AUTHORISATION NUMBER(S) EU/1/13/900/006 
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/13/900/006
Manufacturer AstraZeneca GmbH Tinsdaler Weg 183 22880 Wedel Germany 
Izdelovalec AstraZeneca GmbH Tinsdaler Weg 183 22880 Wedel
This medicinal product must not be used in patients with moderate to severe renal impairment (patients with creatinine clearance [CrCl] < 60 ml/min or estimated glomerular filtration rate [eGFR] < 60 ml/min/1.73 m2, see sections 4.3, 4.4, 4.8, 5.1 and 5.2). 
Tega zdravila se ne sme uporabljati pri bolnikih z zmerno do hudo okvaro ledvic (bolniki z očistkom kreatinina [CrCl] < 60 ml/min ali ocenjeno hitrostjo glomerularne filtracije [eGFR] < 60 ml/min/1,73 m2, glejte poglavja 4.3, 4.4, 4.8, 5.1 in 5.2).
Up-titration of insulin regimens (including short-acting, intermediate, and basal insulin) was only allowed if subjects met pre-defined FPG criteria. 
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.
Contents of the pack and other information 
Shranjevanje zdravila Xigduo Vsebina pakiranja in dodatne informacije
Urinary tract infections were more frequently reported for dapagliflozin compared with placebo (4.7% versus 3.5%, respectively; see section 4.4). 
Okužbe sečil so bile pogosteje opisane z dapagliflozinom kot s placebom (4,7 % v primerjavi s 3,5 %;
Elderly patients are more likely to have impaired renal function, and/or to be treated with anti-hypertensive medicinal products that may cause changes in renal function such as angiotensin-converting enzyme inhibitors (ACE-I) and angiotensin II type 1 receptor blockers (ARB). 
Pri starejših bolnikih je verjetnejša okvara ledvic in/ali zdravljenje z antihipertenzivnimi zdravili, ki lahko povzročijo spremembe v delovanju ledvic, na primer z zaviralci angiotenzinske konvertaze (ACE-I
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Following coadministration of dapagliflozin with mefenamic acid (an inhibitor of UGT1A9), a 55% increase in dapagliflozin systemic exposure was seen, but with no clinically meaningful effect on 24-hour urinary glucose excretion. 
Po sočasni uporabi dapagliflozina in mefenaminske kisline (zaviralca UGT1A9), so zabeležili 55 % povečanje sistemske izpostavljenosti dapagliflozinu, vendar brez klinično pomembnega učinka na 24-urno izločanje glukoze v urinu.
• genital infection (thrush) of your penis or vagina (signs may include irritation, itching, unusual discharge or odour) 
• okužba spolovil (glivice) na spolnem udu ali v nožnici (med znaki so lahko draženje, srbenje, nenavaden izcedek ali neprijeten vonj)
Reported cases of lactic acidosis in patients on metformin have occurred primarily in diabetic patients with significant renal failure. 
Pri sladkornih bolnikih, ki so prejemali metformin, se je laktacidoza pojavila predvsem pri bolnikih s pomembno odpovedjo ledvic.
Therefore, this medicinal product must not be used in patients with moderate to severe renal impairment (patients with CrCl < 60 ml/min or estimated glomerular filtration rate [eGFR] < 60 ml/min/1.73 m2; see section 4.3). 
Zato se tega zdravila ne sme uporabljati pri bolnikih z zmerno do hudo okvaro ledvic (bolniki z očistkom kreatinina < 60 ml/min ali ocenjeno hitrostjo glomerularne filtracije < 60 ml/min/1,73 m2; glejte poglavje 4.3).
What you need to know before you take Xigduo 
Kaj morate vedeti, preden boste vzeli zdravilo Xigduo Ne jemljite zdravila Xigduo
− tablet core: hydroxypropyl cellulose (E463), microcrystalline cellulose (E460(i)), magnesium stearate (E470b), sodium starch glycolate. 
− jedro tablete: hidroksipropilceluloza (E463), mikrokristalna celuloza (E460(i)), magnezijev stearat (E470b), natrijev karboksimetilškrob.
Your doctor may ask you to stop taking this medicine until you recover in order to prevent dehydration. 
Za preprečitev dehidracije vam lahko zdravnik naroči, da nehajte jemati to zdravilo, dokler si ne opomorete.
INFORMATION IN BRAILLE xigduo 5 mg/850 mg 
PODATKI V BRAILLOVI PISAVI xigduo 5 mg/850 mg
INFORMATION IN BRAILLE xigduo 5 mg/1,000 mg 
PODATKI V BRAILLOVI PISAVI xigduo 5 mg/1000 mg
- hypersensitivity to the active substances or to any of the excipients listed in section 6.1; - diabetic ketoacidosis, diabetic pre-coma; - moderate and severe renal impairment (creatinine clearance < 60 ml/min; eGFR < 60 ml/min/1.73 m2) (see sections 4.2, 4.4 and 5.2); - acute conditions with the potential to alter renal function such as: dehydration, severe infection, shock; - acute or chronic disease which may cause tissue hypoxia such as: cardiac or respiratory failure, recent myocardial infarction, shock; - hepatic impairment (see sections 4.2, 4.4 and 5.2); - acute alcohol intoxication, alcoholism (see section 4.5). 
- preobčutljivostjo na zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1, - diabetično ketoacidozo, diabetično predkomo, - zmerno in hudo okvaro ledvic (očistek kreatinina < 60 ml/min, eGFR < 60 ml/min/1,73 m2) (glejte poglavja 4.2, 4.4 in 5.2), - akutnimi motnjami, ki lahko spremenijo delovanje ledvic, kot so npr.: dehidracija, huda okužba, šok,
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 of1.8 mmHg versus -0.5 mmHg systolic and -0.5 mmHg diastolic blood pressure for placebo group at Week 24. 
Krvni tlak 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.
Combination of a single dose of dapagliflozin 20 mg and simvastatin (a CYP3A4 substrate) resulted in a 19% increase in AUC of simvastatin and 31% increase in AUC of simvastatin acid. 
CYP3A4) je povzročila 19 % povečanje AUC simvastatina in 31 % povečanje AUC simvastatinske kisline.
Fungal infection** 
srbenje spolovil**
Add-on combination 
Kombinacija z dodatkom
Metformin, one of the active substances in this medicine, can cause a very rare (may affect up to 1 in 10,000 people) but serious side effect called ‘lactic acidosis'. 
• Laktacidoza: metformin, ena od zdravilnih učinkovin v tem zdravilu, lahko povzroči zelo redek neželen učinek (pojavi se lahko pri največ 1 od 10.000 bolnikov), ki pa je resen; imenujemo ga "laktacidoza".
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. 
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)
Placebo + insulin ± oral glucose-lowering medicinal products2 
Placebo + insulin ± peroralni antidiabetiki2
Adverse reactions in dapagliflozin and metformin immediate-release clinical trial and postmarketing dataa 
Neželeni učinki dapagliflozina in metformina s takojšnjim sproščanjem na podlagi kliničnih preskušanj in postmarketinških podatkova
There is increased risk of lactic acidosis in acute alcohol intoxication (particularly in the case of fasting, malnutrition or hepatic impairment) due to the metformin active substance of this medicinal product (see section 4.4). 
Nepriporočljive kombinacije Zaradi vsebnosti metformina v tem zdravilu obstaja večje tveganje za laktacidozo v primeru akutne intoksikacije z alkoholom (zlasti v primeru postenja, podhranjenosti ali okvare jeter) (glejte poglavje 4.4).
Titanium dioxide (E171) Iron oxide yellow (E172) 
Rdeči železov oksid (E172)
Dapagliflozin 10 mg + insulin ± oral glucose-lowering medicinal products2 
Dapagliflozin 10 mg + insulin ± peroralni antidiabetiki2
• Dehydration: loss of too much fluid from your body, seen uncommonly (may affect up to 1 in 100 people). 
• Dehidracija: čezmerna izguba tekočine iz telesa, ki se pojavi občasno (pojavi se lahko pri največ
• abnormalities in liver function tests, inflammation of the liver (hepatitis) 
• zmanjšana koncentracija vitamina B12 v krvi • nenormalni izvidi preiskav delovanja jeter, vnetje jeter (hepatitis)
The mean steady-state volume of distribution of dapagliflozin was 118 l. 
Povprečni volumen porazdelitve dapagliflozina v stanju dinamičnega ravnovesja je 118 litrov.
Vulvovaginitis, balanitis and related genital infections*,b,c 
Infekcijske in parazitske bolezni vulvovaginitis, balanitis in sorodne okužbe spolovil*,b,c okužba sečil*,b,d glivična okužba**
PHARMACEUTICAL FORM AND CONTENTS 98 film-coated tablets. 
98 filmsko obloženih tablet.
Hydroxypropyl cellulose (E463) Microcrystalline cellulose (E460(i)) Magnesium stearate (E470b) Sodium starch glycolate type A 
Hidroksipropilceluloza (E463) Mikrokristalna celuloza (E460(i)) Magnezijev stearat (E470b)
Diabetic ketoacidosisk Lactic acidosis Vitamin B12 deficiencyh, 
ketoacidozak laktacidoza pomanjkanje vitamina
These are signs of a severe infection of the urinary tract: - fever and/or chills - burning sensation when passing water (urinating) - pain in your back or side. 
- pekoč občutek pri odvajanju vode (uriniranju) - bolečine v hrbtu ali ledveno
At Weeks 24, HbA1c change from baseline in subjects treated with dapagliflozin plus insulin with metformin was -0.93%. 
Po 24 tednih se je HbA1c pri preiskovancih, zdravljenih z dapagliflozinom v kombinaciji z insulinom in metforminom, v primerjavi z izhodiščem spremenil za -0,93 %.
Effect of dapagliflozin on other medicinal products 
Vpliv drugih zdravil na dapagliflozin
Hepatic impairment This medicinal product must not be used in patients with hepatic impairment (see sections 4.3, 4.4 and 
Pri bolnikih z okvaro jeter se tega zdravila ne sme uporabljati (glejte poglavja 4.3, 4.4 in 5.2).
The coadministration of dapagliflozin and metformin has been studied in subjects with type 2 diabetes inadequately controlled on metformin alone or in combination with a DPP-4 inhibitor (sitagliptin), sulphonylurea or insulin. 
Sočasno uporabo dapagliflozina in metformina so raziskali pri preiskovancih s sladkorno boleznijo tipa 2, ki niso bili zadostno urejeni z metforminom samim ali v kombinaciji z zaviralcem DPP-4 (sitagliptin),
Reported by the investigator as possibly related, probably related or related to study treatment and reported in ≥ 0.2% of subjects and ≥ 0.1% more and at least 3 more subjects treated with dapagliflozin 10 mg compared to placebo. 
**Po navedbi raziskovalca morda povezano, verjetno povezano ali povezano s preizkušanim zdravilom ter opisano pri ≥ 0,2 % preiskovancev ter pri ≥ 0,1 % več in pri vsaj 3 preiskovancih več med uporabo 10 mg dapagliflozina kot med uporabo placeba.
Results of a 24-week placebo-controlled study of dapagliflozin in add-on combination with metformin and a sulphonylurea 
Rezultati 24-tedenske, s placebom kontrolirane študije dapagliflozina v kombinaciji z dodatkom metformina in sulfonilsečnine
Patients who may be at higher risk of DKA include patients with a low beta-cell function reserve (e.g. 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. 
Med bolniki s potencialno večjim tveganjem za DKA so bolniki z majhno funkcijsko rezervo celic beta (npr. bolniki s sladkorno boleznijo tipa 2 z nizko vrednostjo C-peptida ali latentno avtoimunsko sladkorno boleznijo odraslih (LADA - latent autoimmune diabetes in adults) ali bolniki z anamnezo pankreatitisa),
Improvement in homeostasis model assessment for beta cell function (HOMA beta-cell) has been observed in clinical studies with dapagliflozin. 
V kliničnih študijah dapagliflozina so ugotovili izboljšanje homeostatske modelne ocene delovanja celic beta
Following an oral dose, the apparent terminal elimination half-life is approximately 6.5 hours. 
Navidezni terminalni razpolovni čas eliminacije je po peroralnem odmerku približno
At Week 12 for both studies, dapagliflozin 10 mg plus usual antidiabetic treatment provided improvement in HbA1c and decreased the placebo-corrected systolic blood pressure on average by 3.1 and 4.3 mmHg, respectively. 
Po 12 tednih je 10 mg dapagliflozina skupaj z običajnim antidiabetičnim zdravljenjem v obeh študijah prineslo izboljšanje HbA1c ter znižanje za placebo korigiranega sistoličnega krvnega tlaka za povprečno
Lactic acidosis is a very rare, but serious (high mortality in the absence of prompt treatment), metabolic complication that can occur due to accumulation of metformin, a component of this medicinal product. 
Laktacidoza je zelo redek, vendar resen presnovni zaplet, ki se lahko pojavi zaradi kopičenja metformina
Vulvovaginitis, balanitis and related genital infections Vulvovaginitis, balanitis and related genital infections were reported in 5.5% and 0.6% of subjects who received dapagliflozin 10 mg and placebo, respectively. 
Vulvovaginitis, balanitis in sorodne okužbe spolovil so bile opisane pri 5,5 % oseb, ki so prejemale 10 mg dapagliflozina, in pri 0,6 % oseb, ki so prejemale placebo.
Polyvinyl alcohol (E1203) Macrogol 3350 (E1520(iii)) Talc (E553b) 
Polivinilalkohol (E1203) Makrogol 3350 (E1520(iii)) Smukec (E553b) Titanov dioksid (E171) Rumeni železov oksid (E172)
These subjects had detectable glucose in the urine for a dose-related period of time (at least 5 days for the 500 mg dose), with no reports of dehydration, hypotension or electrolyte imbalance, and with no clinically meaningful effect on QTc interval. 
Ti preiskovanci so imeli v obdobju, ki je bilo odvisno od odmerka (vsaj 5 dni po odmerku 500 mg), v urinu zaznavno glukozo, brez dehidracije,
NAME OF THE MEDICINAL PRODUCT Xigduo 5 mg/850 mg film-coated tablets 
IME ZDRAVILA Xigduo 5 mg/850 mg filmsko obložene tablete
When Xigduo is used in combination with insulin or an insulin secretagogue such as sulphonylurea, a lower dose of insulin or sulphonylurea may be considered to reduce the risk of hypoglycaemia (see sections 4.5 and 4.8). 
Če se zdravilo Xigduo uporablja v kombinaciji z insulinom ali insulinskim sekretagogom, npr. s sulfonilsečnino, pride v poštev, za zmanjšanje tveganja za hipoglikemijo, zmanjšanje odmerka insulina ali sulfonilsečnine
The signs include rapid weight loss, feeling sick or being sick, stomach pain, fast and deep breathing, sleepiness, a sweet smell to your breath, a sweet or metallic taste in your mouth or a different odour to your urine or sweat. 
bolečine v trebuhu, hitro in globoko dihanje, zaspanost, sladek vonj izdihanega zraka, sladek ali kovinski okus v ustih ali spremenjen vonj urina ali znoja.
In patients with normal renal function or mild renal impairment (baseline eGFR ≥ 60 mL/min/1.73m2) this grouping of reactions were reported in 1.3% and 0.8% of patients who received dapagliflozin 10 mg and placebo, respectively. 
Pri bolnikih z normalnim delovanjem ledvic ali blago okvaro ledvic (izhodiščna ocenjena hitrost glomerularne filtracije [eGFR] ≥ 60 ml/min/1,73 m2) je bila ta skupina učinkov opisana pri 1,3 % bolnikov, ki so prejemali 10 mg dapagliflozina, in pri 0,8 % tistih, ki so prejemali placebo.Te reakcije so bile pogostejše pri bolnikih z izhodiščno ocenjeno hitrostjo glomerularne filtracije
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Geometric mean steady-state dapagliflozin Cmax and AUCτ values following once daily 10 mg doses of dapagliflozin were 158 ng/ml and 628 ng h/ml, respectively. 
Geometrična sredina Cmax in AUCτ dapagliflozina v stanju dinamičnega ravnovesja po odmerkih 10 mg enkrat na dan sta bili 158 ng/ml in
NAME OF THE MEDICINAL PRODUCT Xigduo 5 mg/1,000 mg film-coated tablets 
IME ZDRAVILA Xigduo 5 mg/1000 mg filmsko obložene tablete
Following coadministration of dapagliflozin with rifampicin (an inducer of various active transporters and drug-metabolising enzymes) a 22% decrease in dapagliflozin systemic exposure (AUC) was observed, but with no clinically meaningful effect on 24-hour urinary glucose excretion. 
Po sočasnem jemanju dapagliflozina in rifampicina (induktorja različnih aktivnih prenašalcev in encimov za presnovo zdravil), so zabeležili 22 % zmanjšanje sistemske izpostavljenosti (AUC) dapagliflozinu,
(95% CI) Mean daily insulin dose (IU)1 
Povprečni dnevni odmerek insulina (i.e.)1
Vulvovaginitis, balanitis and related genital infections includes, e.g. the predefined preferred terms: vulvovaginal mycotic infection, vaginal infection, balanitis, genital infection fungal, vulvovaginal candidiasis, vulvovaginitis, balanitis candida, genital candidiasis, genital infection, genital infection male, penile infection, vulvitis, vaginitis bacterial, vulval abscess. 
Vulvovaginitis, balanitis in sorodne okužbe spolovil vključuje npr. definirane prednostne izraze: vulvovaginalna glivična okužba, okužba nožnice, balanitis, glivična okužba spolovil, vulvovaginalna kandidoza, vulvovaginitis,
Therefore, this medicinal product must be discontinued prior to, or at the time of the test and not reinstituted until 48 hours afterwards, and only after renal function has been re-evaluated and found to be normal (see section 4.4). 
Zdravila se ne sme znova uvesti prej kot 48 ur pozneje in to šele potem, ko je bilo delovanje ledvic znova ocenjeno in se je izkazalo za normalno (glejte poglavje 4.4).
Therefore, this medicinal product must be discontinued prior to, or at the time of the test and not reinstituted until 48 hours afterwards, and only after renal function has been re-evaluated and found to be normal (see section 4.5). 
Zdravila se ne sme znova uvesti prej kot 48 ur pozneje in to šele potem, ko je bilo delovanje ledvic znova ocenjeno in se je izkazalo za normalno (glejte poglavje 4.5).
These reactions were more common in patients with baseline eGFR ≥ 30 and < 60 mL/min/1.73m2 (18.5% dapagliflozin 10 mg vs. 9.3% placebo). 
[eGFR] ≥ 30 in < 60 ml/min/1,73 m2 (18,5 % z 10 mg dapagliflozina in 9,3 % s placebom).
Urinary volume increases in subjects with type 2 diabetes mellitus treated with dapagliflozin 10 mg were sustained at 12 weeks and amounted to approximately 375 ml/day. 
Povečana količina urina je bila pri bolnikih s sladkorno boleznijo tipa 2, zdravljenih z 10 mg dapagliflozina, prisotna še 12. teden in je znašala približno
In a 52-week, active-controlled non-inferiority study (with 52- and 104-week extension periods), dapagliflozin 10 mg was evaluated as add-on therapy to metformin compared with a sulphonylurea (glipizide) as add-on therapy to metformin in subjects with inadequate glycaemic control (HbA1c > 6.5% and ≤ 10%). 
104-tedenskim obdobjem podaljšanja) so 10 mg dapagliflozina ocenjevali kot dodatek zdravljenju z metforminom v primerjavi s sulfonilsečnino (glipizid) kot dodatkom zdravljenju z metforminom pri bolnikih z neustrezno urejenostjo glikemije (HbA1c > 6,5 % in ≤ 10 %).
At 52, 104 and 208 weeks, a significantly lower proportion of subjects in the group treated with dapagliflozin (3.5%, 4.3% and 5.0%, respectively) experienced at least one event of hypoglycaemia compared with the group treated with glipizide (40.8%, 47% and 50.0%, respectively). 
52., 104. in 208. teden je imel vsaj eno hipoglikemijo značilno manjši delež preiskovancev v skupini z dapagliflozinom (3,5 %, 4,3 % in
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*,b,d 
h,§
The efficacy of dapagliflozin, a component of this medicinal product, is dependent on renal function, and efficacy is reduced in patients who have moderate renal impairment and likely absent in patients with severe renal impairment (see section 4.2). 
Pri bolnikih z zmerno okvaro ledvic je njegova učinkovitost manjša, pri bolnikih s hudo okvaro ledvic pa verjetno ni učinkovit (glejte poglavje 4.2).
Subjects with mean daily insulin dose reduction of at least 10% (%) 
(95 % IZ) Preiskovanci z znižanjem povprečnega dnevnega odmerka insulina za vsaj