FrancophonIA/ELRC3.0 huggingface dataset:
English: Concomitant administration of saxagliptin with the moderate inhibitor of CYP3A4/5 diltiazem, increased the Cmax and AUC of saxagliptin by 63% and 2.1-fold, respectively, and the corresponding values for the active metabolite were decreased by 44% and 34%, respectively.
Maltese: L-għotja ta' saxagliptin mal-inibitur moderat ta' CYP3A4/5 diltiazem, żied is-Cmax u l-AUC ta' saxagliptin b'63% u 2.1-il darba, rispettivament, u l-valuri tal-metabolu attiv li jikkorrispondu magħhom tnaqqsu b'44% u 34%, rispettivament.
English: There appeared to be no difference in percentage responders: 37.9% (saxagliptin) and 38.2% (glimepiride) achieved the primary endpoint.
Maltese: Jidher li ma kien hemm ebda differenza f'dawk li wieġbu perċentwali: 37.9% (saxagliptin) u 38.2% (glimepiride) laħqu lpunt ta' tmiem primarju.
English: Komboglyze 2.5 mg/850 mg tablets saxagliptin/metformin HCl
Maltese: Komboglyze 2.5 mg/ 850 mg pilloli saxagliptin/metformin HCl
English: Komboglyze 2.5 mg/1,000 mg tablets saxagliptin/metformin HCl
Maltese: Komboglyze 2.5 mg/1,000 mg pilloli saxagliptin/metformin HCl
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.
Maltese: C-saxagliptin, 24%, 36%, u 75% tad-doża kienet imneħħija fl-awrina bħala saxagliptin, il-metabolu ewlieni tiegħu, u r-radjuattività totali rispettivament.
English: • Komboglyze is available in aluminium foil blister.
Maltese: • Komboglyze jiġi ġo folja b'kisja tal-aluminium.
English: In patients at increased risk of further progression of renal impairment and in the elderly, renal function should be assessed more frequently, e.g. every 3-6 months.
Maltese: F'pazjenti b'riskju akbar ta' aktar progressjoni ta' indeboliment renali u fl-anzjani, il-funzjoni renali għandha tkun evalwata b'mod aktar frekwenti, eż. kull 36 xhur.
English: The study included patients with renal impairment classified on the basis of creatinine clearance as mild (approximately GFR ≥ 45 to < 90 mL/min), moderate (approximately GFR ≥ 30 to < 45 mL/min), or severe (approximately GFR < 30 mL/min) renal impairment.
Maltese: L-istudju inkluda pazjenti b'indeboliment renali, ikklassifikat abbażi ta' tneħħija tal-kreatinina bħala ħafifa ( GFR ta' madwar ≥ 45 sa < 90 mL/min), moderata (GFR ta' madwar ≥ 30 sa < 45 mL/min), jew sever (GFR ta' madwar < 30 mL/min).
English: Change from baseline (adjusted mean (95% Confidence interval [CI]) Difference from saxagliptin + metformin (adjusted mean (95% CI)
Maltese: Differenza minn saxagliptin + metformin (medja aġġustata (95 % CI)
English: The primary safety (noninferiority) and efficacy (superiority) endpoint was a composite endpoint consisting of the time-to-first occurrence of any of the following major adverse CV events (MACE): CV death, nonfatal myocardial infarction, or nonfatal ischaemic stroke.
Maltese: Il-punt ta' tmiem primarju tas-sigurtà (noninferjorità) u effikaċja (superjorità) kien punt ta' tmiem kompost magħmul mill-ħin għall-ewwel okkorrenza ta' kwalunkwe wieħed millavvenimenti CV avversi li ġejjin (MACE): mewta CV, infart mijokardijaku mhux fatali, jew puplesija iskemika mhux fatali.
English: 56 film-coated tablets.
Maltese: 56 pillola miksija b'rita.
English: Komboglyze 2.5 mg/850 mg film-coated tablets Komboglyze 2.5 mg/1,000 mg film-coated tablets
Maltese: Komboglyze 2.5 mg/850 mg pilloli miksijin b'rita Komboglyze 2.5 mg/1,000 mg pilloli miksijin b'rita
English: Mean change from baseline HbA1c (%)
Maltese: Medja tal-bidla mil-linja bażi ta' HbA1c (%)
English: Table 4 The frequency of metformin adverse reactions identified from clinical trial and postmarketing data
Maltese: Tabella 4 Il-frekwenza tar-reazzjonijiet avversi b'metformin identifikata minn dejta minn provi kliniċi u wara t-tqegħid fis-suq
English: Table 3 Frequency of additional adverse reactions by system organ class
Maltese: Tabella 3 Frekwenza ta' aktar reazzjonijiet avversi skont is-sistema talklassifikazzjoni tal-organi
English: A study conducted in seven normal healthy volunteers showed that cimetidine, administered as 400 mg twice daily, increased metformin systemic exposure (AUC) by 50% and Cmax by 81%.
Maltese: Studju li sar f'seba' voluntiera b'saħħithom wera li cimetidine, mogħti bħala 400 mg darbtejn kuljum, żied l-esponiment sistemiku għal metformin (AUC) b'50% u s-Cmax b'81%.
English: • tiredness (fatigue).
Maltese: • għeja (eżawriment).
English: SAVOR trial results
Maltese: Riżultati tal-prova SAVOR
English: BLISTERS (PERFORATED/NON-PERFORATED) for Komboglyze 2.5 mg/850 mg tablets
Maltese: FOLJI (IMTAQQBIN/MHUX IMTAQQBIN) għal Komboglyze 2.5 mg/ 850 mg pilloli
English: It is especially important to mention the following: cimetidine, a medicine used to treat stomach problems ketoconazole which is used to treat fungal infections bronchodilators (beta-2 agonists) which are used to treat asthma diltiazem which is used for high blood pressure rifampicin, an antibiotic used to treat infections such as tuberculosis corticosteroids, which are used to treat inflammation in diseases like asthma and arthritis carbamazepine, phenobarbital or phenytoin, which are used to control fits (seizures) or long-term pain medicines which increase urine production (diuretics) medicines used to treat pain and inflammation (NSAID and COX-2-inhibitors, such as ibuprofen and celecoxib) certain medicines for the treatment of high blood pressure (ACE inhibitors and angiotensin II receptor antagonists).
Maltese: - cimetidine, mediċina li tintuża għall-kura ta' problemi fl-istonku - ketoconazole li jintuża għall-kura ta' infezzjonijiet kontra l-moffa - bronkodilataturi (agonisti ta' beta-2) li jintużaw għall-kura tal-ażżma - pilloli tal-ilma (‘dijuretiċi') li jintużaw biex iżidu l-ammont ta' ilma li tgħaddi - diltiazem li jintuża għall-kura ta' pressjoni għolja tad-demm - rifampicin, antibijotiku li jintuża għall-kura ta' infezzjonijiet bħal tuberikulożi - kortikosterojdi, li jintużaw għall-kura ta' infjammazzjoni u mard bħal ażżma u artrite - carbamazepine, phenobarbital jew phenytoin li jintużaw biex jikkontrollaw attakki talqamar (aċċessjonijiet) jew uġigħ fit-tul mediċini li jżidu l-produzzjoni tal-awrina (dijuretiċi) mediċini użati għall-kura tal-uġigħ u l-infjammazzjoni (NSAID u inibituri COX-2, bħal ibuprofen u celecoxib) ċerti mediċini għall-kura tal-pressjoni għolja tad-demm (inibituri ACE u antagonisti tarriċeturri angiotensin II).
English: The average renal clearance of saxagliptin (230 mL/min) was greater than the average estimated glomerular filtration rate (120 mL/min), suggesting some active renal excretion.
Maltese: Il-medja tat-tneħħija ta' saxagliptin mill-kliewi (~230 mL/min) kienet akbar mill-medja stmata għar-rata ta' filtrazzjoni mill-glomeruli (~120 mL/min), li tindika li hemm xi forma ta' tneħħija renali attiva.
English: BLISTERS (PERFORATED/NON-PERFORATED) for Komboglyze 2.5 mg/1,000 mg tablets
Maltese: FOLJI (IMTAQQBIN/MHUX IMTAQQBIN) għal Komboglyze 2.5 mg/1,000 mg pilloli
English: Reductions in HbA1c from baseline to Week 24 were observed in all evaluated subgroups defined by baseline HbA1c, with greater reductions observed in patients with a baseline HbA1c ≥ 10% (see Table 5).
Maltese: Tnaqqis flHbA1c mil-linja bażi sa' Ġimgħa 24 deher fis-sottogruppi kollha li ġew evalwati hekk kid definiti bl-HbA1c mal-linja bażi, u deher aktar tnaqqis f'pazjenti b'linja bażi ta' HbA1c ≥ 10% (ara Tabella 5).
English: Rash has been seen with saxagliptin and with certain anti-diabetic medicines in the same class as saxagliptin.
Maltese: Raxx deher b'saxagliptin u b'ċerti mediċini kontra d-dijabete fl-istess klassi ta' saxagliptin.
English: Komboglyze 2.5 mg/850 mg film-coated tablets Polyvinyl alcohol
Maltese: Komboglyze 2.5 mg/850 mg pilloli miksijin b'rita Polyvinyl alcohol
English: In randomised, controlled, double-blind clinical trials (including developmental and postmarketing experience), over 17,000 patients with type 2 diabetes have been treated with saxagliptin.
Maltese: Fi provi kliniċi randomizzati, ikkontrollati, double-blind (inkluż esperjenza tal-iżvilupp u ta' wara t-tqegħid fis-suq), aktar minn 17,000 pazjent b'dijabete tip 2 ġew ikkurati b'saxagliptin.
English: The intent-to-treat analysis showed consistent results.
Maltese: L-analiżi bl-intenzjoni-li-tikkura wriet riżultati konsistenti.
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.
Maltese: Il-bidla fl-HbA1c għal saxagliptin 5 mg ma' metformin (n=31) imqabbla ma' plaċebo ma' metformin (n=15) kienet -0.8% f'Ġimgħa 102.
English: The effect on offspring body weights were noted until postnatal day 92 and 120 in females and males, respectively.
Maltese: L-effett fuq ilpiżijiet tal-wild kienu eżaminati sa' jum 92 u 120 wara t-twelid fil-firien femminili u maskili, rispettivament.
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:
Maltese: 12-il ġimgħa Saxa 2.5 mg darbtejn kuljum miżjud ma' metformin; Studju CV181080 (n=74) Studji miżjuda/ kombinati ma' terapiji addizjonali Miżjud mal-insulina (+/- metformin) Saxa 5 mg kuljum, Studju CV181057: Popolazzjoni globali (n=300) 24-ġimgħa Saxa 5 mg kuljum miżjud ma' metformin flimkien ma' sulphonylurea; Studju D1680L00006 (n=257) Saxa 5 mg kuljum miżjud ma' metformin flimkien ma' dapagliflozin Studju CV181168 (n=315)
English: In controlled clinical trials, maximum metformin plasma levels (Cmax) did not exceed 4 μg/mL, even at maximum doses.
Maltese: Fi provi kliniċi kontrollati, l-ogħla livelli ta' metformin fil-plażma (Cmax) ma qabżux l-4 µg/mL, anki bl-ogħla dożi.
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]).
Maltese: HbA1c ta' 7.9% għall-grupp ta' saxagliptin u 8.0% għall-grupp talplaċebo), u tnaqqis akbar fl-FFG (-13.73 mg/dL kontra -4.22 mg/dL) iżda mingħajr sinifikat statistiku (p=0.12, 95% CI
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.
Maltese: Saxagliptin ikkawża tossiċità gastrointestinali fil-klieb, inkluż ippurgar bid-demm/ mukuż u enetropatija b'dożi ogħla b'NOEL 4 darbiet u darbtejn l-esponiment ta' saxagliptin u lmetabolu ewlieni tiegħu fil-bniedem, rispettivament, b'RHD.
English: If no adequate strength of Komboglyze is available, individual monocomponents should be used instead of the fixed dose combination.
Maltese: Jekk ma tkunx disponibbli qawwa adegwata ta' Komboglyze, għandhom jiġu użati monokomponenti individwali minflok il-kombinazzjoni ta' doża fissa.
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.
Maltese: Komboglyze 2.5 mg/850 mg pilloli miksijin b'rita Kull pillola fiha 2.5 mg ta' saxagliptin (bħala l-hydrochloride) u 850 mg ta' metformin hydrochloride.
English: Komboglyze 2.5 mg/1,000 mg film-coated tablets Polyvinyl alcohol
Maltese: Komboglyze 2.5 mg/1,000 mg pilloli miksijin b'rita Polyvinyl alcohol
English: The percent of subjects with reported on-treatment events of major hypoglycaemia (defined as an event that required assistance of another person) was higher in the saxagliptin group than in the placebo group (2.1% and 1.6%, respectively).
Maltese: Ilperċentwal ta' individwi b'avvenimenti waqt il-kura rrapportati ta' ipoġliċemija maġġuri (definit bħala avveniment li ħtieġ l-assistenza ta' persuna oħra) kien ogħla fil-grupp ta' saxagliptin milli fil-grupp tal-plaċebo (2.1% u 1.6%, rispettivament).
English: System organ class Adverse reaction
Maltese: Sistema tal-klassifika tal-organi Reazzjoni avversa
English: A single-dose, open-label study was conducted to evaluate the pharmacokinetics of a 10 mg oral dose of saxagliptin in subjects with varying degrees of chronic renal impairment compared to subjects with normal renal function.
Maltese: Studju b'doża waħda, open-label sar biex jevalwa l-farmakokinetika ta' doża orali ta' 10 mg saxagliptin f'individwi bi gradi varji ta' indeboliment renali kroniku mqabbla ma' individwi b'funzjoni renali normali.
English: After an oral dose, the non-absorbed fraction recovered in faeces was 20-30%.
Maltese: Wara doża orali, il-frazzjoni li kienet irkuprata mill-ippurgar kienet 20-30%.
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%).
Maltese: It-twaqqif tat-terapija minħabba l-AEs kienet ogħla fil-pazjenti li kienu qed jirċievusaxagliptin 5 mg meta mqabbla mal-plaċebo (3.3% imqabbla ma' 1.8%).
English: No benefit was observed for MACE or all-cause mortality.
Maltese: Ma ġiex osservat benefiċċju għal MACE jew mortalità minn kull kawża.
English: In addition, patients should be alerted to the risk of hypoglycaemia when Komboglyze is used in combination with other antidiabetic medicinal products known to cause hypoglycaemia (e.g. insulin, sulphonylureas).
Maltese: Barra minn hekk, il-pazjenti għandhom jiġu mwissija bir-riskju ta' ipogliċemija meta Komboglyze jintuża f'kombinazzjoni ma' prodotti mediċinali antidijabetiċi magħrufin li jikkawżaw ipogliċemija (eż. insulina, sulphonylureas).
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.
Maltese: Saxagliptin miżjud ma' metformin imqabbel ma' sitagliptin miżjud ma' metformin Studju ta' 18-il ġimgħa sar biex jevalwa l-effikaċja u s-sigurtà ta' saxagliptin 5 mg flimkien ma' metformin (403 pazjent), imqabbel ma' sitagliptin 100 mg flimkien ma' metformin (398 pazjent) fi 801 pazjent b'kontroll gliċemiku mhux xieraq b'metformin waħdu.
English: The effect in HbA1c observed at Week 24 was sustained at Week 52.
Maltese: L-effett fuq HbA1c osservat wara Ġimgħa 24 kien sostnut f'Ġimgħa 52.
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.
Maltese: Saxagliptin u dapagliflozin miżjudin ma' terapija ta' metformin Total ta' 534 pazjent adult b'dijabete mellitus tat-Tip 2 u li ma kellhomx kontroll xieraq tazzokkor fid-demm b'metformin waħdu (HbA1c 8 %-12 %), ipparteċipaw f'din il-prova ta' 24 ġimgħa, randomizzata, double-blind, ikkontrollata b'komparatur attiv sabiex titqabbel ittaħlita ta' saxagliptinu u dapagliflozin miżjuda fl-istess ħin ma' metformin, kontra saxagliptin jew dapagliflozin miżjud ma' metformin.
English: As add-on to metformin: dyspepsia (common) and myalgia (common).
Maltese: Bħala monoterapija: sturdament (komuni) u għejja (komuni).
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.
Maltese: Il-frekwenza ta' glucose baxx fid-demm irrappurtat kien 3.4% f'pazjenti ġodda għall-kura mogħtija 5 mg saxagliptin ma' metformin u 4.0% f'pazjenti li ngħataw metformin waħdu.
English: Mechanism of action and pharmacodynamic effects Komboglyze combines two antihyperglycaemic medicinal products with complementary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: saxagliptin, a dipeptidyl peptidase 4 (DPP4) inhibitor, and metformin hydrochloride, a member of the biguanide class.
Maltese: Komboglyze jikkombina żewġ sustanzi kontra l-ipergliċemija b'mekkaniżmi kumplimentari sabiex itejjeb il-kontroll gliċemiku f'pazjenti b'dijabete tat-tip 2: saxagliptin, inibitur dipeptidyl peptidase 4 (DPP4), u metformin hydrochloride, membru tal-klassi biguanide.
English: Talk to your doctor for further instructions.
Maltese: Kellem littabib tiegħek għal aktar istruzzjonijiet.
English: The co-administration of saxagliptin and CYP3A4/5 inducers, other than rifampicin (such as carbamazepine, dexamethasone, phenobarbital and phenytoin) have not been studied and may result in decreased plasma concentration of saxagliptin and increased concentration of its major metabolite.
Maltese: L-għotja ta' saxagliptin u indutturi ta' CYP3A4/5, minbarra rifampicin (bħal carbamazepine, dexamethasone, phenobarbital u phenytoin) ma kienux studjati u jista' jwassal għal tnaqqis fil-konċentrazzjoni ta' saxagliptin fil-plażma u żieda fil-konċentrazzjoni tal-metabolu ewlieni tiegħu.
English: Maximum total daily dose is 2.5 mg.
Maltese: Id-doża totali massima ta' kuljum hija 2.5 mg.
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].
Maltese: Komponent wieħed tal-punt ta' tmiem kompost sekondarju, rikoveru l-isptar għal kollass talqalb, seħħ b'rata akbar fil-grupp ta' saxagliptin (3.5%) meta mqabbel mal-grupp tal-plaċebo (2.8%), b'sinifikat statistiku nominali li jiffavorixxi plaċebo [HR = 1.27; (95% CI 1.07, 1.51); P = 0.007]. Fatturi klinikament relevanti ta' riskju relattiv miżjud bil-kura ta' saxagliptin ma setgħux jiġu identifikati b'mod definittiv.
English: Food had relatively modest effects on the pharmacokinetics of saxagliptin in healthy subjects.
Maltese: L-ikel kellu effetti relattivament modesti fuq il-farmakokinetika ta' saxagliptin f'individwi b'saħħithom.
English: Decreased lymphocyte counts were reported in 0.5% of saxagliptin-treated patients and 0.4% of placebo-treated patients.
Maltese: Ġew irrapportati għadd ta' limfoċiti mnaqqsa f'0.5% tal-pazjenti kkurati b'saxagliptin u 0.4% tal-pazjenti kkurati bi plaċebo.
English: For patients inadequately controlled on dual combination therapy of a sulphonylurea and metformin, or for patients switching from triple combination therapy of saxagliptin, metformin and a sulphonylurea taken as separate tablets
Maltese: Għal pazjenti mhux ikkontrollati b'mod adegwat fuq terapija doppja kombinata ta' sulphonylurea u metformin, jew għal pazjenti li jaqilbu minn terapija tripla kombinata ta' saxagliptin, metformin u sulphonylurea meħuda bħala pilloli separati
English: Saxagliptin add-on to metformin therapy
Maltese: L-għotja ta' saxagliptin u metformin
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.
Maltese: Saxagliptin wassal ukoll għal proporzjon aktar baxx ta' pazjenti b'ipogliċemija, 3% (19 il-każ f'13-il individwu) vs. 36.3% (750 każijiet f'156 individwu) għal glipizide.
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.
Maltese: • Komboglyze 2.5 mg/1,000 mg huma pilloli miksijin b'rita (‘pilloli') ovali sofor ċari jagħtu fis-safrani, b' “2.5/1000” ittimbrati fuq naħa waħda u “4247” ittimbrati fuq innaħa l-oħra, b'linka ċelesti.
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).
Maltese: Punt ta' tmiem sekondarju ieħor, il-mortalità minn kull kawża, seħħet b'rata ta' 5.1% filgrupp ta' saxagliptin u 4.6% fil-grupp tal-plaċebo (ara Tabella 7).
English: The mean plasma terminal half-life (t1/2) values for saxagliptin and its major metabolite are 2.5 hours and 3.1 hours respectively, and the mean t1/2 value for plasma DPP4 inhibition was 26.9 hours.
Maltese: Il-medja tal-valuri tal-half-life (t1/2 ) terminali fil-plażma għal saxagliptin u l-metabolu ewlieni tiegħu huma 2.5 sigħat u 3.1 sigħat rispettivament, u l-medja tal-valur t1/2 għall-inibizzjoni ta' DPP4 fil-plażma kienet 26.
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%).
Maltese: Terapija ta' kombinazzjoni miżjuda ta' saxagliptin b'metformin u sulphonylurea Total ta' 257 pazjent b'dijabete tip 2 ħadu sehem fi studju ta' 24 ġimgħa, randomizzat, double-blind, ikkontrollat bi plaċebo sabiex jiġu evalwati l-effikaċja u s-sigurtà ta' saxagliptin (5 mg darba kuljum) f'kombinazzjoni ma' metformin flimkien ma' sulphonylurea (SU) f'pazjenti b'kontroll gliċemiku mhux adegwat (HbA1c ≥7% u ≤10%).
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.
Maltese: Wara doża orali waħidha ta' 5 mg ta' saxagliptin lill-individwi b'saħħithom, il-medja tal-valuri tal-AUC fil-plażma ta' saxagliptin u l-metabolu ewlieni tiegħu kienu 78 ng h/mL u 214 ng h/mL, rispettivament.
English: It is assumed that the pharmacokinetics of metformin absorption is non-linear.
Maltese: Huwa meqjus li l-farmakokinetika tal-assorbiment ta' metformin mhuwiex linejari.
English: No metabolites have been identified in humans.
Maltese: Ma ġewx identifikati metaboliti filbnedmin.
English: Each tablet contains 2.5 mg of saxagliptin (as hydrochloride) and 850 mg of metformin hydrochloride.
Maltese: Kull pillola fiha 2.5 mg saxagliptin (bħala hyrdrochloride) u 850 mg ta' metformin hydrochloride.
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.
Maltese: Il-bidla tal-HbA1c għal saxagliptin 5 mg ma' metformin (n=177) imqabbel ma' metformin mal-plaċebo (n=147) kienet -0.5% f'Ġimgħa 76.
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].
Maltese: Rikoveru l-isptar għal kollass tal-qalb, seħħ b'rata akbar fil-grupp ta' saxagliptin (3.5%) meta mqabbel mal-grupp tal-plaċebo (2.8%), b'sinifikat statistiku nominali li jiffavorixxi l-plaċebo [HR = 1.27; 95% CI 1.07, 1.51); P = 0.007]. Ara wkoll sezzjoni 5
English: Table 7 Primary and secondary clinical endpoints by treatment group in the SAVOR study*
Maltese: Punti ta' tmiem kliniċi primarji u sekondarji skont il-grupp ta' kura flistudju SAVOR*
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-naive patients with inadequate glycaemic control (HbA1c 8-12%).
Maltese: Saxagliptin flimkien ma' metformin bħala terapija tal-bidu Studju ta' 24-il ġimgħa sar biex jevalwa l-effikaċja u s-sigurtà ta' saxagliptin 5 mg flimkien ma' metformin bħala terapija kombinata tal-bidu f'pazjenti naive għall-kura b'kontroll gliċemiku mhux xieraq (HbA1c 8-12%).