FrancophonIA/ELRC3.0 huggingface dataset:
English: No dose- and time-dependence was observed in the clearance of saxagliptin and its major metabolite over 14 days of once-daily dosing with saxagliptin at doses ranging from 2.5 mg to 400 mg.
Croatian: Nije primijećeno da klirens saksagliptina i njegovog glavnog metabolita ovise o dozi i vremenu tijekom 14 dana primjene saksagliptina jedanput dnevno u rasponu doza od 2,5 mg do 400 mg j.
English: Saxagliptin produced gastrointestinal toxicity in dogs, including bloody/mucoid faeces and enteropathy at higher doses with a NOEL 4 and 2 times the human exposure for saxagliptin and the major metabolite, respectively, at RHD.
Croatian: Saksagliptin je izazvao gastrointestinalnu toksičnost u pasa, uključujući krvavu/sluzavu stolicu i enteropatiju pri višim dozama gdje je NOEL bila 4 puta veća od izloženosti ljudi saksagliptinu i 2 puta veća od izloženosti njegovu glavnom metabolitu pri RHD.
English: Following a single 50 mg dose of C-saxagliptin, 24%, 36%, and 75% of the dose was excreted in the urine as saxagliptin, its major metabolite, and total radioactivity respectively.
Croatian: C-saksagliptina, 24% se izlučilo mokraćom u obliku saksagliptina, 36% u obliku njegova glavnog metabolita, a 75% kao ukupna radioaktivnosti.
English: • Study CV181014: add-on to metformin (n=186)
Croatian: • Ispitivanje CV181014: dodatak metforminu (n=186)
English: • Common: dizziness, tiredness, stomach ache and flatulence.
Croatian: • Često: omaglica, umor, bol u želucu i vjetrovi.
English: Saxagliptin (n=250) provided significant improvements in HbA1c, FPG, and PPG compared to titration to a higher dose of glibenclamide (n=264).
Croatian: Saksagliptin (n=250) je doveo do značajnih poboljšanja vrijednosti HbA1c, FPG-a i PPG-a u usporedbi s glibenklamidom (n=264) titriranim na višu dozu.
English: In a pre- and postnatal developmental study in rats, saxagliptin caused decreased pup weight at maternally toxic doses, with NOEL 488 and 45 times the human exposure for saxagliptin and the major metabolite, respectively at RHD.
Croatian: U ispitivanjima prenatalnog i postnatalnog utjecaja na razvoj u štakora, saksagliptin je uzrokovao smanjenje težine mladunaca pri dozama toksičnima za majku, uz NOEL 488 odnosno 45 puta veći od ljudske izloženosti saksagliptinu odnosno njegovom glavnom metabolitu pri RHD.
English: Saxagliptin should be used with caution in patients with moderate hepatic impairment, and is not recommended for use in patients with severe hepatic impairment (see section 4.4).
Croatian: Saksagliptin je potrebno primjenjivati s oprezom u bolesnika s umjerenim oštećenjem jetrene funkcije, a ne preporučuje se njegova primjena u bolesnika s teškim oštećenjem jetre (vidjeti dio 4.4).
English: The incidence of hypersensitivity reactions was 1.1% in both Onglyza-treated patients and placebotreated patients.
Croatian: Incidencija reakcija preosjetljivosti iznosila je 1,1% i u bolesnika liječenih lijekom Onglyza i u onih koji su primali placebo.
English: A total of 4,148 patients with type 2 diabetes, including 3,021 patients treated with, saxagliptin were randomised in 6 double-blind, controlled clinical safety and efficacy studies conducted to evaluate the effects of saxagliptin on glycaemic control.
Croatian: Ukupno je 4148 bolesnika sa šećernom bolešću tipa 2, uključujući 3021 bolesnika liječenih saksagliptinom, bilo randomizirano u šest dvostruko slijepih, kontroliranih kliničkih ispitivanja sigurnosti i djelotvornosti primjene provedenih zbog procjene učinaka saksagliptina na kontrolu glikemije.
English: Table 3 HbA1c at Week 24 in active-controlled study comparing the combination of saxagliptin and dapagliflozin added concurrently to metformin with either saxagliptin or dapagliflozin added to metformin
Croatian: Tablica 3: HbA1c u 24. tjednu u ispitivanju kontroliranom aktivnim lijekom koje je uspoređivalo kombinaciju saksagliptina i dapagliflozina istovremeno pridodanu metforminu, sa ili saksagliptinom ili dapagliflozinom pridodanim metforminu
English: • Study CV181040: add-on to SU (n=250)
Croatian: • Ispitivanje CV181040: dodatak SU (n=250)
English: It is unknown whether saxagliptin is excreted in human breast milk.
Croatian: Nije poznato izlučuje li se saksagliptin u majčino mlijeko u ljudi.
English: Glycaemic control
Croatian: Kontrola glikemije
English: How to take Onglyza
Croatian: Kako uzimati lijek Onglyza
English: • Study CV181013: add-on to TZD (n=183)
Croatian: • Ispitivanje CV181013: dodatak TZD (n=183)
English: 2 from baseline HbA1c (%) at Week 24
Croatian: 2 od početne vrijednosti HbA1c (%) u 24. tjednu
English: If you are having haemodialysis then Onglyza is not recommended for you;
Croatian: Ukoliko ste podvrgnuti hemodijalizi, Onglyza Vam se ne preporučuje.
English: In subjects with mild renal impairment, the mean AUC values of saxagliptin and its major metabolite were 1.2- and 1.7- fold higher, respectively, than mean AUC values in subjects with normal renal function.
Croatian: U ispitanika s blagim oštećenjem bubrega, prosječan AUC saksagliptina bio je 1,2 puta, a njegova glavnog metabolita 1,7 puta viši od prosječnog AUC-a u ispitanika s normalnom funkcijom bubrega.
English: In studies conducted in healthy subjects, neither the pharmacokinetics of saxagliptin nor its major metabolite, were meaningfully altered by metformin, glibenclamide, pioglitazone, digoxin, simvastatin, omeprazole, antacids or famotidine.
Croatian: U ispitivanjima provedenim u zdravih ispitanika primjena metformina, glibenklamida, pioglitazona, digoksina, simvastatina, omeprazola, antacida ili famotidina nije značajno promijenila farmakokinetiku saksagliptina ni njegova glavnog metabolita.
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).
Croatian: Saksagliptin kao dodatak kombiniranoj terapiji s inzulinom (sa ili bez metformina) Ukupno je 455 bolesnika sa šećernom bolešću tipa 2 sudjelovalo u randomiziranom, dvostruko slijepom, placebom kontroliranom ispitivanju u trajanju od 24 tjedna koje je provedeno da se utvrdi djelotvornosti i sigurnosti primjene saksagliptina u kombinaciji sa stabilnom dozom inzulina (prosječna početna doza: 54,2 jedinice) u bolesnika koji su imali neadekvatnu kontrolu glikemije (HbA1c ≥ 7,5% i ≤ 11%) na terapiji samo s inzulinom (n=141) ili inzulinom u kombinaciji sa stabilnom dozom metformina (n=314).
English: Saxagliptin as monotherapy
Croatian: Saksagliptin kao monoterapija
English: The HbA1c change for saxagliptin compared to placebo was -0.7% at Week 24.
Croatian: Promjena vrijednosti HbA1c pri uzimanju saksagliptina u usporedbi s placebom iznosila je -0,7% u 24. tjednu.
English: • Tablet core: lactose monohydrate; cellulose, microcrystalline (E460i); croscarmellose sodium (E468); magnesium stearate.
Croatian: • Jezgra tablete: laktoza hidrat; mikrokristalična celuloza (E460i); umrežena karmelozanatrij
English: They have “5” printed on one side and “4215” printed on the other side, in blue ink.
Croatian: Na jednoj strani imaju plavom tintom otisnutu oznaku „5“, a na drugoj „4215“.
English: One component of the secondary composite endpoint, 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].
Croatian: Stopa jedne komponente sekundarne kompozitne mjere ishoda - hospitalizacije zbog zatajenja srcabila je veća u skupini liječenoj saksagliptinom (3,5%) nego u onoj koja je primala placebo (2,8%), s nominalnom statističkom značajnošću u korist placeba [HR = 1,27; (95% CI 1,07; 1,51); P = 0,007].
English: Mean HbA1c change is the difference between the saxagliptin+metformin and metformin alone groups (p<0.0001).
Croatian: Prosječna promjena vrijednosti HbA1c odnosi se na razliku između skupine koja je primala saksagliptin+metformin i skupine koja je primala samo metformin (p<0,0001).
English: Saxagliptin in combination with metformin as initial therapy A 24-week study was conducted to evaluate the efficacy and safety of saxagliptin 5 mg in combination with metformin as initial combination therapy in treatment-naïve patients with inadequate glycaemic control (HbA1c 8-12%).
Croatian: Saksagliptin u kombinaciji s metforminom kao početna terapija Ispitivanje u trajanju od 24 tjedna provedeno je zbog procjene djelotvornosti i sigurnosti saksagliptina od 5 mg u kombinaciji s metforminom kao početne kombinirane terapije u bolesnika s neodgovarajućom kontrolom glikemije (HbA1c 8%-12%) koji se prethodno nisu liječili.
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.
Croatian: Potvrđene ili teške događaje hipoglikemije imao je manji udio bolesnika u skupini liječenoj saksagliptinom (1,1%) u usporedbi sa skupinom koja je primala glimepirid (15,3%).
English: Onglyza 5 mg film-coated tablets Each tablet contains 5 mg saxagliptin (as hydrochloride).
Croatian: Onglyza 5 mg filmom obložene tablete Jedna tableta sadrži 5 mg saksagliptina (u obliku saksagliptinklorida).
English: Mean HbA1c change is the difference between the saxagliptin+metformin and metformin alone groups.
Croatian: Prosječna promjena vrijednosti HbA1c odnosi se na razliku između skupine koja je primala saksagliptin+metformin i skupine koja je primala samo metformin.
English: Saxagliptin add-on to metformin compared with SU 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 a 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.
Croatian: Ispitivanje u trajanju od 52 tjedna provedeno je zbog procjene djelotvornost i sigurnost primjene saksagliptina od 5 mg u kombinaciji s metforminom (428 bolesnika) u usporedbi sa sulfonilurejom (glipizid, 5 mg titrirano prema potrebi do 20 mg, prosječna doza iznosila je 15 mg) u kombinaciji s metforminom (430 bolesnika) u 858 bolesnika s neodgovarajućom kontrolom glikemije (HbA1c 6,5%-10%) koji su se liječili samo metforminom.
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 (a SGLT2-inhibtor) and metformin.
Croatian: Saksagliptin kao dodatak terapiji dapagliflozinom plus metforminom Randomizirano, dvostruko slijepo, placebom kontrolirano ispitivanje u trajanju od 24 tjedna provedeno u bolesnika sa šećernom bolesti tipa 2 usporedilo je primjenu saksagliptina 5 mg sa placebom kao dodatak terapiji u pojedinaca sa HbA1c 7-10,5% liječenih dapagliflozinom (inhibitorom SGLT2) i metforminom.
English: Onglyza 2.5 mg film-coated tablets Each tablet contains 2.5 mg saxagliptin (as hydrochloride).
Croatian: Onglyza 2,5 mg filmom obložene tablete Jedna tableta sadrži 2,5 mg saksagliptina (u obliku saksagliptinklorida).
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.
Croatian: Ispitivanje u trajanju od 18 tjedana provedeno je zbog procjene djelotvornost i sigurnost primjene saksagliptina od 5 mg u kombinaciji s metforminom (403 bolesnika) u usporedbi sa sitagliptinom od 100 mg u kombinaciji s metforminom (398 bolesnika) u 801 bolesnika s neodgovarajućom kontrolom glikemije koji su se liječili samo metforminom.
English: Titanium dioxide (E171) Talc (E553b)
Croatian: makrogol 3350 titanijev dioksid (E171) talk (E553b) željezov oksid, crveni (E172)
English: Musculoskeletal and connective tissue disorders Arthralgia
Croatian: Poremećaji mišićnokoštanog sustava i vezivnog tkiva
English: Saxagliptin (n=183) provided significant improvements in HbA1c, FPG, and PPG compared to placebo (n=180).
Croatian: Saksagliptin (n=183) je značajno poboljšao vrijednosti HbA1c, FPG-a i PPG-a u usporedbi s placebom (n=180).
English: Abdominal pain† Common Common Common
Croatian: Poremećaji probavnog sustava bol u abdomenu†
English: Saxagliptin as add-on to metformin plus a sulphonylurea
Croatian: saksagliptin s tiazolidindionom saksagliptin kao dodatak metforminu plus sulfonilureji
English: The HbA1c change for saxagliptin 5 mg plus metformin (n=31) compared to placebo plus metformin (n=15) was -0.8% at Week 102.
Croatian: Promjena vrijednosti HbA1c uz saksagliptin od 5 mg i metformin (n=31) u usporedbi s placebom uz metformin (n=15) iznosila je -0,8% u 102. tjednu.
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.
Croatian: Saksagliptin i dapagliflozin kao dodatak terapiji metforminom Ukupno je 534 odraslih bolesnika sa šećernom bolešću tipa 2 i neprimjerenom kontrolom glikemije, koji su primali samo metformin (HbA1c 8%-12%) sudjelovalo u randomiziranom, dvostruko slijepom ispitivanju kontroliranom aktivnim komparatorom u trajanju od 24 tjedna kako bi se usporedila kombinacija saksagliptina i dapagliflozina istovremeno pridodanih metforminu, sa saksagliptinom ili dapagliflozinom pridodanim metforminu.
English: How to store Onglyza
Croatian: Kako čuvati lijek Onglyza
English: The incidence of adjudicated pancreatitis events was 0.3% in both Onglyza-treated patients and placebo-treated patients in the intent-to-treat population.
Croatian: U populaciji koju se namjeravalo liječiti incidencija događaja prosuđenih kao pankreatitis iznosila je 0,3% i u bolesnika liječenih lijekom Onglyza i u onih koji su primali placebo.
English: Each film-coated tablet contains 2.5 mg saxagliptin (as hydrochloride).
Croatian: Jedna filmom obložena tableta sadrži 2,5 mg saksagliptina (u obliku saksagliptinklorida).
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 glycemic control (HbA1c ≥ 7% and ≤ 10%).
Croatian: Saksagliptin kao dodatak kombiniranoj terapiji metforminom i sulfonilurejom Ukupno je 257 bolesnika sa šećernom bolešću tipa 2 sudjelovalo u randomiziranom, dvostruko slijepom, placebom kontroliranom ispitivanju u trajanju od 24 tjedna, koje je provedeno kako bi se ocijenile djelotvornost i sigurnosti primjene saksagliptina (5 mg jedanput dnevno) u kombinaciji s metforminom i sulfonilurejom (SU) u bolesnika s neodgovarajućom kontrolom glikemije (HbA1c ≥ 7 % i ≤ 10%).
English: • Common (may affect 1 to 10 users in 100): infection of the upper chest or lungs, infection of the urinary tract, inflamed stomach or gut usually caused by an infection (gastroenteritis), infection of the sinuses with a feeling of pain and fullness behind your cheeks and eyes (sinusitis), inflamed nose or throat (nasopharyngitis) (signs of this may include a cold or a sore throat), headache, muscle pain (myalgia), vomiting, inflammation of the stomach (gastritis), stomach ache and indigestion (dyspepsia).
Croatian: • Česte (mogu se javiti u 1 do 10 na 100 osoba): infekcija u gornjem dijelu prsnog koša ili plućima, infekcija mokraćnih puteva, upala želuca ili crijeva obično uzrokovana infekcijom (gastroenteritis), infekcija sinusa uz bol i začepljenost iza obraza i očiju (sinusitis), upala nosa ili grla (nazofaringitis) (znakovi mogu obuhvaćati prehladu ili grlobolju), glavobolja, bol u mišićima (mialgija), povraćanje, upala želuca (gastritis), bol u želucu i probavne smetnje (dispepsija).
English: Change from baseline (adjusted mean (95% Confidence interval [CI])
Croatian: Promjena od početne vrijednosti (prilagođena srednja vrijednost (95% Interval pouzdanosti [CI]) Razlika u odnosu na saksagliptin + metformin (prilagođena srednja vrijednost (95% CI)
English: Some patients have had the following side effects while taking Onglyza and metformin and a sulphonylurea:
Croatian: Neki bolesnici imali su sljedeće nuspojave za vrijeme uzimanja lijeka Onglyza i metformina i sulfonilureje:
English: Each film-coated tablet contains 5 mg saxagliptin (as hydrochloride).
Croatian: Jedna filmom obložena tableta sadrži 5 mg saksagliptina (u obliku saksagliptinklorida).
English: Onglyza 2.5 mg film-coated tablets Onglyza 5 mg film-coated tablets
Croatian: Onglyza 2,5 mg filmom obložene tablete Onglyza 5 mg filmom obložene tablete
English: From a baseline mean absolute lymphocyte count of approximately 2,200 cells/μl, a mean decrease of approximately 100 cells/μl relative to placebo was observed in the placebo-controlled-pooled analysis.
Croatian: Analiza objedinjenih podataka iz placebom kontroliranih ispitivanja pokazala je prosječno smanjenje od približno 100 stanica/µl, u odnosu na placebo, od početne srednje vrijednosti apsolutnog broja limfocita od približno 2200 stanica/µl.
English: Onglyza 5 mg tablets saxagliptin
Croatian: Onglyza 5 mg tablete saksagliptin
English: • Study CV181038 (n=69)
Croatian: • Ispitivanje CV181011 (n=103) • Ispitivanje CV181038 (n=69)
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.
Croatian: SAVOR je bilo ispitivanje kardiovaskularnih ishoda provedeno u 16 492 bolesnika s vrijednostima HbA1c od ≥ 6,5% i < 12% (12 959 bolesnika s potvrđenom kardiovaskularnom bolešću;
English: Improvements in HbA1c, PPG, and FPG following treatment with saxagliptin 5 mg plus metformin were sustained up to Week 102.
Croatian: Poboljšane vrijednosti HbA1c, PPG-a i FPG-a nakon liječenja saksagliptinom od 5 mg i metforminom održale su se do 102. tjedna.
English: Some patients have had the following side effects while taking Onglyza and metformin:
Croatian: Neki bolesnici imali su sljedeće nuspojave za vrijeme uzimanja lijeka Onglyza i metformina:
English: Saxagliptin add-on to thiazolidinedione therapy
Croatian: Saksagliptin kao dodatak terapiji tiazolidindionom
English: Pack sizes of 14, 28, 56 and 98 film-coated tablets in non-perforated blisters.
Croatian: Veličine pakiranja od 14, 28, 56 i 98 filmom obloženih tableta u neperforiranim blisterima.
English: Pack sizes of 14, 28, and 98 film-coated tablets in non-perforated calendar blisters.
Croatian: Veličine pakiranja od 14, 28 i 98 filmom obloženih tableta u neperforiranim kalendarskim blisterima.
English: The HbA1c change for saxagliptin 5 mg (n=82) compared to TZD plus placebo (n=53) was -0.9% at Week 76.
Croatian: Promjena vrijednosti HbA1c pri uzimanju saksagliptina od 5 mg (n=82) u odnosu na placebo s TZD (n=53) iznosila je -0,9% u 76. tjednu.
English: BLISTERS (PERFORATED/NON-PERFORATED) for Onglyza 5 mg tablets
Croatian: BLISTERI (PERFORIRANI / NEPERFORIRANI) za Onglyza 5 mg tablete
English: Pack sizes of 14, 28, 56 and 98 film-coated tablets in non-perforated calendar blisters.
Croatian: Veličine pakiranja od 14, 28, 56 i 98 filmom obloženih tableta u neperforiranim kalendarskim blisterima.
English: Glycaemic control should be carefully assessed when saxagliptin is used concomitantly with a potent CYP3A4/5 inducer.
Croatian: Kad se saksagliptin primjenjuje istodobno sa potentnim induktorom CYP3A4/5, treba pažljivo procijeniti regulaciju glikemije.
English: CALENDAR BLISTERS (NON-PERFORATED) for Onglyza 5 mg tablets
Croatian: KALENDARSKI OZNAČEN BLISTER (NEPERFORIRANI) za Onglyza 5 mg tablete
English: The HbA1c change for saxagliptin 5 mg plus metformin (n=177) compared to metformin plus placebo (n=147) was -0.5% at Week 76.
Croatian: Promjena HbA1c pri uzimanju saksagliptina od 5 mg s metforminom (n=177) u usporedbi s uzimanjem placeba s metforminom (n=147) iznosila je -0,5% u 76. tjednu.
English: BLISTERS (PERFORATED/NON-PERFORATED) for Onglyza 2.5 mg tablets
Croatian: BLISTERI (PERFORIRANI / NEPERFORIRANI) za Onglyza 2,5 mg tablete
English: A placebo-controlled study of 24-week duration was conducted to evaluate the efficacy and safety of saxagliptin in combination with a thiazolidinedione (TZD) in patients with inadequate glycaemic control (HbA1c 7-10.5%) on TZD alone.
Croatian: Placebom kontrolirano ispitivanje u trajanju od 24 tjedna provedeno je da bi se procijenila djelotvornost i sigurnost primjene saksagliptina u kombinaciji s tiazolidindionom (TZD) u bolesnika s neodgovarajućom kontrolom glikemije (HbA1c 7%-10,5%) koji su uzimali samo tiazolidindionom.
English: Metabolism and nutrition disorders Hypoglycaemia
Croatian: Poremećaji metabolizma i prehrane hipoglikemija vrlo često dislipidemija manje često hipertrigliceri demija manje često
English: printed on one side and “4214” printed on the other side, in blue ink.
Croatian: Na jednoj strani imaju plavom tintom otisnutu oznaku „2.5“, a na drugoj „4214“.
English: CALENDAR BLISTERS (NON-PERFORATED) for Onglyza 2.5 mg tablets
Croatian: KALENDARSKI OZNAČEN BLISTER (NEPERFORIRANI) za Onglyza 2,5 mg tablete
English: Reductions in HbA1c were seen across subgroups including gender, age, race, and baseline body mass index (BMI) and higher baseline HbA1c was associated with a greater adjusted mean change from baseline with saxagliptin.
Croatian: Smanjenje vrijednosti HbA1c opaženo je u svim podskupinama po spolu, dobi, rasi i početnom indeksu tjelesne mase (BMI).
English: An add-on placebo-controlled study of 24-week duration was conducted to evaluate the efficacy and safety of saxagliptin in combination with glibenclamide in patients with inadequate glycaemic control at enrollment (HbA1c 7.5-10%) on a sub-maximal dose of glibenclamide alone.
Croatian: Placebom kontrolirano ispitivanje saksagliptina u trajanju od 24 tjedna provedeno je zbog procjene djelotvornosti i sigurnosti saksagliptina u kombinaciji s glibenklamidom u bolesnika s neodgovarajućom kontrolom glikemije (HbA1c 7,5%-10%) pri uključenju u ispitivanje uz uzimanje submaksimalne doze samo glibenklamida.
English: Improvements in HbA1c, PPG and FPG following initial therapy with saxagliptin 5 mg plus metformin were sustained up to Week 76.
Croatian: Poboljšane vrijednosti HbA1c, PPG-a i FPG-a nakon početnog liječenja saksagliptinom od 5 mg i metforminom održale su se do 76. tjedna.
English: The HbA1c change for saxagliptin 5 mg (n=56) compared to uptitrated glibenclamide plus placebo (n=27) was -0.7% at Week 76.
Croatian: Promjena HbA1c pri uzimanju saksagliptina od 5 mg (n=56) u usporedbi s placebom s glibenklamidom titriranim na višu dozu (n=27) iznosila je -0,7% u 76. tjednu.
English: Onglyza 5 mg film-coated tablets
Croatian: Onglyza 5 mg filmom obložene tablete
English: Onglyza 2.5 mg film-coated tablets
Croatian: Onglyza 2,5 mg filmom obložene tablete