FrancophonIA/ELRC3.0 huggingface dataset:
English: After an oral dose of metformin, tmax is reached in 2.5 h. Absolute bioavailability of a 500 mg metformin tablet is approximately 50-60% in healthy subjects.
Slovak: Absolútna biologická dostupnosť 500 mg tablety metformínu je u zdravých jedincov približne 50-60
English: Another secondary endpoint, all-cause mortality, occurred at a rate of 5.1% in the saxagliptin group and 4.6% in the placebo group (see Table 7).
Slovak: % v skupine so saxagliptínom a 4,6 % v skupine s placebom (pozri tabuľku 7).
English: Mean baseline HbA1c
Slovak: HbA1c
English: Nervous system disorders Metallic taste
Slovak: Poruchy nervového systému Kovová pachuť v ústach
English: Diagnostic laboratory findings are decreased blood pH (< 7.35), increased plasma lactate levels above 5 mmol/L, and an increased anion gap and lactate/pyruvate ratio.
Slovak: 5 mmol/l) a zvýšená aniónová medzera a pomer laktátu/pyruvátu.
English: Saxagliptin plus metformin was not associated with significant changes from baseline in fasting serum lipids compared to metformin alone.
Slovak: Liečba saxagliptínom v kombinácii s metformínom v porovnaní s liečbou metformínom samotným nespôsobila významné zmeny hladín lipidov v sére nalačno oproti východiskovému stavu.
English: As monotherapy: dizziness (common) and fatigue (common).
Slovak: Ako monoterapia: závraty (častý výskyt) a únava (častý výskyt).
English: 2 (see sections 4.3 and 4.4)
Slovak: Hypersenzitívne reakcie 2 (pozri časti 4.3 a 4.4)
English: Saxagliptin 5 mg add-on to insulin with or without metformin provided significant improvements after 24 weeks in HbA1c and PPG compared with placebo add-on to insulin with or without metformin.
Slovak: 314) zúčastnilo 455 pacientov s diabetom typu 2. Saxagliptín 5 mg pridaný k liečbe inzulínom s alebo bez metformínu viedol počas 24 týždňov k významnému zlepšeniu v HbA1c a PPG v porovnaní s placebom pridaným k liečbe inzulínom s metformínom alebo bez neho.
English: Saxagliptin also resulted in a significantly lower proportion of patients with hypoglycaemia, 3% (19 events in 13 subjects) vs. 36.3% (750 events in 156 patients) for glipizide.
Slovak: %) kvôli nedostatočnej účinnosti na základe kritéria FPG. Saxagliptínom sa dosiahol významne nižší podiel pacientov s hypoglykémiou, 3 % (19 príhod u 13 pacientov) vs. 36,3
English: Improvements in HbA1c, PPG, and FPG following treatment with saxagliptin 5 mg plus metformin were sustained up to Week 102.
Slovak: 175) signifikantne zlepšil hodnoty HbA1c, FPG a PPG. Zlepšenie hodnôt HbA1c, PPG a FPG po liečbe saxagliptínom 5 mg spolu s metformínom sa zachovalo až do 102.
English: A lower proportion of patients in the saxagliptin group (44.7%) compared to the glimepiride group (54.7%) achieved an HbA1c target of 7.0%.
Slovak: Nižší podiel pacientov v skupine so saxagliptínom (44,7
English: Komboglyze 2.5 mg/850 mg film-coated tablets Komboglyze 2.5 mg/1,000 mg film-coated tablets
Slovak: Komboglyze 2,5 mg/850 mg filmom obalené tablety Komboglyze 2,5 mg/1 000 mg filmom obalené tablety
English: • Komboglyze 2.5 mg/850 mg film-coated tablets (‘tablets') are light brown to brown and round, with “2.5/850” printed on one side and “4246” printed on the other side, in blue ink.
Slovak: Komboglyze 2,5 mg/850 mg filmom obalené tablety („tablety“) sú svetlohnedé až hnedé a okrúhle, s atramentovo modrým označením „2.5/850“ na jednej strane a „4246“ na druhej strane.
English: Hospitalisation for heart failure, occurred at a greater rate in the saxagliptin group (3.5%) compared with the placebo group (2.8%), with nominal statistical significance favouring placebo [HR = 1.27; 95% CI 1.07, 1.51); P = 0.007].
Slovak: %) s nominálnou štatistickou významnosťou v prospech placeba [HR=1,27; 95 % CI 1,07, 1,51); P =
English: Komboglyze 2.5 mg/1,000 mg film-coated tablets Each tablet contains 2.5 mg of saxagliptin (as hydrochloride) and 1,000 mg of metformin hydrochloride.
Slovak: Komboglyze 2,5 mg/1 000 mg filmom obalené tablety Každá tableta obsahuje 2,5 mg saxagliptínu (ako hydrochlorid) a 1000 mg metformíniumchloridu.
English: Saxagliptin add-on to dapagliflozin plus metformin therapy A 24-week randomised, double-blind, placebo-controlled study conducted in patients with type 2 diabetes mellitus compared saxagliptin 5 mg with placebo as add-on therapy in individuals with HbA1c 7-10.5% treated with dapagliflozin (SGLT2-inhibtor) and metformin.
Slovak: V 24-týždňovej randomizovanej, dvojito zaslepenej, placebom kontrolovanej štúdii uskutočnenej u pacientov s diabetes mellitus typu 2 sa porovnával saxagliptín v dávke 5 mg s placebom ako prídavná liečba u pacientov s HbA1c 7-10,5 % liečených dapagliflozínom (inhibítor SGLT2)
English: Komboglyze 2.5 mg/850 mg film-coated tablets Each tablet contains 2.5 mg of saxagliptin (as hydrochloride) and 850 mg of metformin hydrochloride.
Slovak: Komboglyze 2,5 mg/850 mg filmom obalené tablety Každá tableta obsahuje 2,5 mg saxagliptínu (ako hydrochlorid) a 850 mg metformíniumchloridu.
English: Symptoms can include, but are not limited to, increasing shortness of breath, rapid increase in weight and swelling of the feet (pedal oedema);
Slovak: Príznaky môžu zahŕňať zhoršenie dýchavičnosti, rýchle priberanie a opuch chodidiel (edém nôh), aj iné príznaky.
English: How to take Komboglyze
Slovak: Ako užívať Komboglyze
English: Saxagliptin add-on to metformin compared with sulphonylurea add-on to metformin A 52-week study was conducted to evaluate the efficacy and safety of saxagliptin 5 mg in combination with metformin (428 patients) compared with sulphonylurea (glipizide, 5 mg titrated as needed to 20 mg, mean dose of 15 mg) in combination with metformin (430 patients) in 858 patients with inadequate glycaemic control (HbA1c 6.5-10%) on metformin alone.
Slovak: Vykonalo sa 52-týždňové klinické skúšanie na hodnotenie účinnosti a bezpečnosti saxagliptínu 5 mg v kombinácii s metformínom (428 pacientov) v porovnaní so sulfonylmočovinou (glipizid 5 mg titrovaný podľa potreby do 20 mg, priemerná dávka 15 mg) v kombinácii s metformínom (430 pacientov)
English: Light brown to brown, biconvex, round, film-coated tablets, with “2.5/850” printed on one side and “4246” printed on the other side, in blue ink.
Slovak: Svetlohnedé až hnedé, bikonvexné, okrúhle, filmom obalené tablety s atramentovo modrým označením „2.5/850“ na jednej strane a „4246“ na druhej strane.
English: Effects on fertility were observed in male and female rats at high doses producing overt signs of toxicity.
Slovak: Pri vysokých dávkach vyvolávajúcich zjavné príznaky toxicity sa u samíc a samcov potkanov pozorovali účinky na fertilitu.
English: • Komboglyze 2.5 mg/1,000 mg film-coated tablets (‘tablets') are pale yellow to light yellow and oval, with “2.5/1000” printed on one side and “4247” printed on the other side, in blue ink.
Slovak: Komboglyze 2,5 mg/1 000 mg filmom obalené tablety („tablety“) sú bledožlté až svetložlté a oválne, s atramentovo modrým označením „2.5/1000“ na jednej strane a „4247“ na druhej strane.
English: Saxagliptin add-on to metformin compared with sitagliptin add-on to metformin An 18-week study was conducted to evaluate the efficacy and safety of saxagliptin 5 mg in combination with metformin (403 patients), compared with sitagliptin 100 mg in combination with metformin (398 patients) in 801 patients with inadequate glycaemic control on metformin alone.
Slovak: Vykonalo sa 18-týždňové klinické skúšanie u 801 pacientov s nedostatočnou kontrolou glykémie pri liečbe metformínom samotným, na hodnotenie účinnosti a bezpečnosti saxagliptínu 5 mg v kombinácii s metformínom (403 pacientov) v porovnaní so sitagliptínom 100 mg v kombinácii s metformínom (398 pacientov).
English: Mean HbA1c change is the difference between the saxagliptin 5 mg + dapagliflozin + metformin and dapagliflozin + metformin groups (p< 0.0001).
Slovak: Priemerná zmena hodnoty HbA1c je rozdiel medzi skupinami saxagliptín 5 mg + dapagliflozín + metformín a dapagliflozín + metformín (p <
English: PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING
Slovak: BYŤ UVEDENÉ NA VNÚTORNOM OBALE
English: After 18 weeks, saxagliptin was non-inferior to sitagliptin in mean reduction from baseline in HbA1c in both the per-protocol and the full analysis sets.
Slovak: Po 18 týždňoch tak v analýze všetkých randomizovaných pacientov ako aj v celom analyzovanom súbore nebol účinok saxagliptínu na priemerné zníženie hodnôt HbA1c v porovnaní s východiskovým stavom nižší ako účinok sitagliptínu.
English: Add-on/initial combination with metformin studies 24-weeks Saxa 5 mg daily add-on to metformin; Study CV181014 (n=186) Saxa 5 mg daily initial combination with metformin; Study CV181039 Overall population (n=306) Baseline HbA1c ≥ 10% stratum (n=107)
Slovak: Prídavná/iniciálna kombinácia v skúšaniach s metformínom24-týždňov Saxa 5 mg denne ako prídavná liečba k metformínu; Skúšanie CV181014 (n =
English: Saxagliptin twice daily add-on to metformin therapy An add-on to metformin placebo-controlled study of 12-week duration was conducted to evaluate the efficacy and safety of saxagliptin 2.5 mg twice daily in combination with metformin in patients with inadequate glycaemic control (HbA1c 7-10%) on metformin alone.
Slovak: Prídavná liečba saxagliptínom dvakrát denne k liečbe metformínom Sledovanie prídavnej liečby saxagliptínom k liečbe metformínom sa uskutočnilo v 12-týždňovom skúšaní kontrolovanom placebom, s cieľom hodnotenia účinnosti a bezpečnosti saxagliptínu 2,5 mg dvakrát denne v kombinácii s metformínom u pacientov s nedostatočnou kontrolou glykémie (HbA1c 7-10
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Slovak: Ak teraz užívate alebo ste v poslednom čase užívali, či práve budete užívať ďalšie lieky, povedzte to svojmu lekárovi.
English: Factors that may increase the risk of lactic acidosis (see section 4.4) should be reviewed before considering initiation of Komboglyze in patients with GFR < 60 mL/min.
Slovak: Pred zvážením začiatku liečby liekom Komboglyze u pacientov s GFR < 60 ml/min je potrebné posúdiť faktory, ktoré by mohli zvyšovať riziko laktátovej acidózy (pozri časť 4.4).
English: Saxa 2.5 mg twice daily add-on to metformin; Study CV181080 (n=74) Add-on/combination studies with additional therapies Add-on to insulin (+/- metformin) Saxa 5 mg daily, Study CV181057:
Slovak: Saxa 2,5 mg dvakrát denne ako prídavná liečba k metformínu; skúšanie CV181080 (n =
English: A 3-month dog study was conducted with the combination of saxagliptin and metformin.
Slovak: S kombináciou saxagliptínu a metformínu sa vykonalo trojmesačné skúšanie na psoch.
English: Discontinuation of therapy due to AEs was higher in patients who received saxagliptin 5 mg as compared to placebo (3.3% as compared to 1.8%).
Slovak: Počet prípadov prerušenia liečby kvôli nežiaducim udalostiam bol u pacientov užívajúcich saxagliptín 5 mg vyšší ako v skupine s placebom (3,3
English: Do not take Komboglyze - If you are allergic to saxagliptin, metformin or any of the other ingredients of this medicine (listed in section 6); - If you have had a serious allergic (hypersensitive) reaction to any other similar medications that you take to control your blood sugar.
Slovak: Ak ste alergický na saxagliptín, metformín alebo na ktorúkoľvekzďalších zložiek tohto lieku (uvedených včasti6);
English: Rash has been seen with saxagliptin and with certain anti-diabetic medicines in the same class as saxagliptin.
Slovak: Pri liečbe saxagliptínom a liečbe s inými liekmi na cukrovku patriacimi do rovnakej skupiny ako je saxagliptín sa vyskytovala vyrážka.
English: When used as add-on to metformin plus a sulphonylurea, the overall incidence of reported hypoglycaemia was 10.1% for saxagliptin 5 mg and 6.3% for placebo.
Slovak: Keď sa použil ako prídavná liečba ku metformínu a sulfonylmočovine, zaznamenal sa celkový výskyt hypoglykémie 10,1
English: Table 4 presents adverse reactions by system organ class and by frequency category.
Slovak: Údaje z klinického skúšania a po uvedení lieku na trh Tabuľka 4 uvádza nežiaduce reakcie podľa triedy orgánových systémov a podľa kategórie frekvencie ich výskytu.
English: Co-administration of saxagliptin and metformin
Slovak: Súbežné podávanie saxagliptínu a metformínu
English: The overall incidence of reported hypoglycaemia (recorded in daily patient diaries) was 17.1% in subjects treated with saxagliptin and 14.8% among patients treated with placebo.
Slovak: Celkový výskyt hlásenej hypoglykémie (zaznamenaný v denníkoch pacientov) bol 17,1
English: Saxagliptin add-on to metformin therapy
Slovak: Saxagliptín pridaný k liečbe dapagliflozínom a metformínom
English: Do not take this medicine if you are breast-feeding or plan to breast-feed.
Slovak: Neužívajte tento liek, ak dojčíte, alebo máte v úmysle dojčiť, pretože metformín v malých množstvách prechádza do materského mlieka.
English: Komboglyze 2.5 mg/1,000 mg film-coated tablets Polyvinyl alcohol
Slovak: Komboglyze 2,5 mg/1 000 mg filmom obalené tablety Polyvinylalkohol
English: Frequency
Slovak: Frekvencia výskytu
English: A lower proportion of patients in the saxagliptin group (1.1%) compared to the glimepiride group (15.3%), experienced a confirmed or severe hypoglycaemic event.
Slovak: %) v porovnaní so skupinou s glimepiridom (15,3
English: Printing ink
Slovak: Atramentová potlač
English: Komboglyze 2.5 mg/1,000 mg film-coated tablets
Slovak: Komboglyze 2,5 mg/1 000 mg filmom obalené tablety
English: After 12 weeks, the saxagliptin group (n=74) had a greater HbA1c mean reduction from baseline than the placebo group (n=86) (-0.6% vs. -0.2%, respectively, difference of -0.34%, from a mean baseline HbA1c of 7.9% for the saxagliptin group and 8.0% for the placebo group), and a greater FPG reduction (-13.73 mg/dL versus -4.22 mg/dL) but without statistical significance (p=0.12, 95% CI [-21.68; 2.66]).
Slovak: % pre placebo) a väčšie zníženie hodnôt FPG (-13,73 mg/dl vs. -4,22 mg/dl), ale bez štatistickej významnosti (p =
English: Komboglyze 2.5 mg/850 mg film-coated tablets
Slovak: Komboglyze 2,5 mg/850 mg filmom obalené tablety
English: - a significant reduction of the absolute risk of any diabetes-related complication in the metformin group (29.8 events/1,000 patient-years) versus diet alone (43.3 events/1,000 patient-years), p=0.0023, and versus the combined sulphonylurea and insulin monotherapy groups (40.1 events/1,000 patient-years), p=0.0034; - a significant reduction of the absolute risk of any diabetes-related mortality: metformin 7.5 events/1,000 patient-years, diet alone 12.7 events/1,000 patient-years, p=0.017; - a significant reduction of the absolute risk of overall mortality: metformin 13.5 events/1,000 patient-years versus diet alone 20.6 events/1,000 patient-years, (p=0.011), and versus the combined sulphonylurea and insulin monotherapy groups 18.9 events/1,000 patient-years (p=0.021); - a significant reduction in the absolute risk of myocardial infarction: metformin 11 events/1,000 patient-years, diet alone 18 events/1,000 patient-years, (p=0.01).
Slovak: 0,017; - významný pokles absolútneho rizika celkovej mortality: metformín 13,5 prípadov/1000 pacientorokov vs diéta samotná 20,6 prípadov/1000 pacientorokov (p =
English: GENERAL CLASSIFICATION FOR SUPPLY
Slovak: Priemerný distribučný objem
English: There was a numerical imbalance in non-CV death, with more events on saxagliptin (1.8%) than placebo (1.4%) [HR = 1.27; (95% CI 1.00, 1.62); P = 0.051].
Slovak: Pri non-KV úmrtiach bola zistená numerická nerovnováha, viac udalostí bolo pri saxagliptíne (1,8
English: Each film-coated tablet contains 2.5 mg saxagliptin (as hydrochloride) and 850 mg metformin hydrochloride.
Slovak: Každá filmom obalená tableta obsahuje 2,5 mg saxagliptínu (ako hydrochlorid) a 850 mg metformíniumchloridu.
English: Immune system disorders Hypersensitivity reactions
Slovak: Poruchy imunitného systému
English: Komboglyze 2.5 mg/850 mg film-coated tablets Polyvinyl alcohol
Slovak: Komboglyze 2,5 mg/850 mg filmom obalené tablety Polyvinylalkohol
English: Following a 5 mg single oral dose of saxagliptin to healthy subjects, the mean plasma AUC values for saxagliptin and its major metabolite were 78 ng·h/mL and 214 ng·h/mL, respectively.
Slovak: Hodnoty Cmax a AUC saxagliptínu a jeho hlavného metabolitu vzrastali priamo úmerne so zvyšovaním dávky saxagliptínu a táto dávková proporcionalita sa zistila pri dávkach až do 400 mg. Po podaní jednotlivej perorálnej dávky 5 mg saxagliptínu zdravým jedincom boli priemerné plazmatické hodnoty AUC saxagliptínu 78 ng·h/ml a jeho hlavného metabolitu 214 ng·h/ml.
English: Mean change from baseline HbA1c (%)
Slovak: Priemerná zmena hodnoty HbA1c
English: When used as add-on to insulin (with or without metformin), the overall incidence of reported hypoglycaemia was 18.4% for saxagliptin 5 mg and 19.9% for placebo.
Slovak: %, v skupine pacientov liečených metformínom samotným 4 %. Pri použití saxagliptínu 5 mg ako doplnku k liečbe inzulínom (s metformínom alebo bez neho) bol celkový výskyt hlásení hypoglykémie 18,4
English: Each film-coated tablet contains 2.5 mg saxagliptin (as hydrochloride) and 1,000 mg metformin hydrochloride.
Slovak: Každá filmom obalená tableta obsahuje 2,5 mg saxagliptínu (ako hydrochlorid) a 1000 mg metformíniumchloridu.
English: An add-on to metformin placebo-controlled study of 24-week duration was conducted to evaluate the efficacy and safety of saxagliptin in combination with metformin in patients with inadequate glycaemic control (HbA1c 7-10%) on metformin alone.
Slovak: Prídavná liečba saxagliptínom k liečbe metformínom Pridanie k metformínu v placebom kontrolovanom klinickom skúšaní v trvaní 24 týždňov sa uskutočnilo za účelom hodnotiť účinnosť a bezpečnosť saxagliptínu v kombinácii s metformínom u pacientov s nedostatočnou kontrolou glykémie (HbA1c 7-10
English: * (uncommon), myalgia
Slovak: * (menej častý výskyt),
English: There were 4,148 patients with type 2 diabetes, including 3,021 patients treated with saxagliptin, randomised in six double-blind, controlled clinical safety and efficacy studies conducted to evaluate the effects of saxagliptin on glycaemic control.
Slovak: V rámci šiestich dvojito-zaslepených, kontrolovaných klinických skúšaní bezpečnosti a účinnosti zameraných na hodnotenie účinku saxagliptínu na kontrolu glykémie bolo randomizovaných 4148 pacientov s diabetes mellitus typu 2, vrátane 3021 pacientov liečených saxagliptínom.
English: Each tablet contains 2.5 mg of saxagliptin (as hydrochloride) and 850 mg of metformin hydrochloride.
Slovak: Každá tableta obsahuje 2,5 mg saxagliptínu (vo forme hydrochloridu) a 850 mg metformíniumchloridu.
English: The incidence of reported hypoglycaemia was 3.4% in treatment-naive patients given saxagliptin 5 mg plus metformin and 4.0% in patients given metformin alone.
Slovak: % vs. 5 %. Výskyt hlásenej hypoglykémie pre kombináciu saxagliptín 5 mg a metformín u pacientov bez predchádzajúcej liečby predstavoval 3,4
English: Titanium dioxide (E171) Talc (E553b)
Slovak: Mastenec (E553b)
English: The proportion of patients achieving HbA1c < 7% at Week 24 was higher in the saxagliptin 5 mg plus dapagliflozin plus metformin group 35.3% (95% CI [28.2, 42.4]) compared to the placebo plus dapagliflozin plus metformin group 23.1% (95% CI [16.9, 29.3]).
Slovak: 7 % v 24. týždni bol vyšší v skupine so saxagliptínom v dávke 5 mg plus dapagliflozínom plus metformínom 35,3
English: Komboglyze 2.5 mg/1,000 mg film-coated tablets saxagliptin/metformin
Slovak: Komboglyze 2,5 mg/1 000 mg filmom obalené tablety saxagliptín/metformín
English: Komboglyze 2.5 mg/850 mg film-coated tablets saxagliptin/metformin
Slovak: Komboglyze 2,5 mg/850 mg filmom obalené tablety saxagliptín/metformín
English: Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes MellitusThrombolysis in Myocardial Infarction (SAVOR) Study SAVOR was a CV outcome trial in 16,492 patients with HbA1c ≥ 6.5% and < 12% (12959 with established CV disease; 3533 with multiple risk factors only) who were randomised to saxagliptin (n=8280) or placebo (n=8212) added to regional standards of care for HbA1c and CV risk factors.
Slovak: % (12 959 s diagnostikovaným KV ochorením, 3 533 len s viacerými rizikovými faktormi), ktorí boli randomizovaní na saxagliptín (n =
English: Komboglyze 2.5 mg/850 mg tablets saxagliptin/metformin HCl
Slovak: Komboglyze 2,5 mg/850 mg filmom obalené tablety saxagliptin/metformin HCl
English: The reduction in FPG was slightly less in the saxagliptin group and there were more discontinuations (3.5% vs. 1.2%) due to lack of efficacy based on FPG criteria during the first 24 weeks of the study.
Slovak: Počas prvých 24 týždňov štúdie bolo zníženie FPG o niečo menšie v skupine so saxagliptínom a liečba bola viackrát prerušená (3,5
English: Saxagliptin and dapagliflozin add-on to metformin therapy A total of 534 adult patients with type 2 diabetes mellitus and inadequate glycaemic control on metformin alone (HbA1c 8%-12%), participated in this 24-week randomised, double-blind, active comparator-controlled trial to compare the combination of saxagliptin and dapagliflozin added concurrently to metformin, versus saxagliptin or dapagliflozin added to metformin.
Slovak: Saxagliptín a dapagliflozín pridaný k liečbe metformínom Celkovo 534 dospelých pacientov s diabetes mellitus typu 2 a nedostatočnou kontrolu glykémie samotným metformínom (HbA1c 8 % - 12
English: Komboglyze 2.5 mg/1,000 mg tablets saxagliptin/metformin HCl
Slovak: Komboglyze 2,5 mg/1 000 mg filmom obalené tablety saxagliptin/metformin HCl
English: Each tablet contains 2.5 mg of saxagliptin (as hydrochloride) and 1,000 mg of metformin hydrochloride.
Slovak: Každá tableta obsahuje 2,5 mg saxagliptínu (vo forme hydrochloridu) a 1 000 mg metformíniumchloridu.
English: Initial therapy with the combination of saxagliptin 5 mg plus metformin (n=306) provided significant improvements in HbA1c, FPG, and PPG compared to with either saxagliptin (n=317) or metformin (n=313) alone as initial therapy.
Slovak: 306) významne zlepšila hodnoty HbA1c, FPG a PPG v porovnaní s iniciálnou liečbou tak saxagliptínom samotným (n =
English: The incidence of adjudicated pancreatitis events was 0.3% in both saxagliptin-treated patients and placebo-treated patients in the intent-to-treat population.
Slovak: % u pacientov liečených saxagliptínom aj u pacientov, ktorí užívali placebo.
English: The HbA1c change for the saxagliptin group (n=244) compared to placebo (n=124) was -0.4% at Week 52.
Slovak: týždni bola zmena HbA1c -0,4 % pre skupinu so saxagliptínom (n =
English: Saxagliptin add-on combination therapy with metformin and sulphonylurea A total of 257 patients with type 2 diabetes participated in a 24-week randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of saxagliptin (5 mg once daily) in combination with metformin plus sulphonylurea (SU) in patients with inadequate glycaemic control (HbA1c ≥ 7% and ≤ 10%).
Slovak: Celkovo sa v 24-týždňovej randomizovanej, dvojito zaslepenej, placebom kontrolovanej štúdii s cieľom vyhodnotiť účinnosť a bezpečnosť saxagliptínu (5 mg raz denne) v kombinácii s metformínom plus sulfonylmočovinou u pacientov s nedostatočnou kontrolou glykémie (HbA1c ≥7
English: Saxagliptin add-on combination therapy with insulin (with or without metformin) A total of 455 patients with type 2 diabetes participated in a 24-week randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of saxagliptin in combination with a stable dose of insulin (baseline mean: 54.2 Units) in patients with inadequate glycaemic control (HbA1c ≥ 7.5% and ≤ 11%) on insulin alone (n=141) or on insulin in combination with a stable dose of metformin (n=314).
Slovak: Celkovo sa v 24-týždňovej randomizovanej, dvojito zaslepenej, placebom kontrolovanej štúdii s cieľom vyhodnotiť účinnosť a bezpečnosť saxagliptínu v kombinácii so stabilnou dávkou inzulínu (východisková hodnota: 54,2 jednotiek) u pacientov s nedostatočnou kontrolou glykémie (HbA1c ≥
English: Komboglyze 2.5 mg/850 mg film-coated tablets saxagliptin/metformin hydrochloride
Slovak: Komboglyze 2,5 mg/850 mg filmom obalené tablety saxagliptín/metformíniumchlorid