natgillin/translations-raw huggingface dataset:
I alt 22 % af den administrerede radioaktivitet blev genfunden i fæces og udgjorde den fraktion af saxagliptindosis som udskilles i galden og/eller uabsorberet lægemiddel fra den gastrointestinale tragt. 
A total of 22% of the administered radioactivity was recovered in faeces representing the fraction of the saxagliptin dose excreted in bile and/or unabsorbed medicinal product from the gastrointestinal tract.
Metabolisme og ernæring Hypoglykæmi 
Metabolism and nutrition disorders Hypoglycaemia
Brug ikke lægemidlet efter den udløbsdato, der står på blister og pakning efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned. 
Do not use this medicine after the expiry date which is stated on the blister and the carton after EXP.
Reduktioner i HbA1c fra baseline frem til uge 24 blev observeret hos alle evaluerede undergrupper, defineret ud fra baseline HbA1c, med større reduktioner set hos patienter med en baseline HbA1c ≥ 10 % (se tabel 3). 
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 2).
Akut pankreatitis 
Acute Pancreatitis
Derudover skal patienterne advares om risikoen for hypoglykæmi, når Onglyza anvendes i kombination med andre antidiabetika, der er kendt for at medføre hypoglykæmi (f.eks. insulin, sulfonylurinstoffer). 
In addition, patients should be alerted to the risk of hypoglycaemia when Onglyza is used in combination with other antidiabetic medicinal products known to cause hypoglycaemia (e.g. insulin, sulphonylureas).
I begge studier medførte behandling med saxagliptin en gang daglig signifikante forbedringer i HbA1c (se tabel 3). 
In both studies, once-daily treatment with saxagliptin provided significant improvements in HbA1c (see Table 2).
Dyrestudier har påvist reproduktionstoksicitet ved høje doser (se pkt. 
Studies in animals have shown reproductive toxicity at high doses (see section 5.3).
2 fra baseline HbA1c(%) i uge 24 
2 from baseline HbA1c (%) at Week 24
Bivirkninger, der er identificeret i forbindelse med overvågningen efter markedsføring. 
Adverse reactions were identified through postmarketing surveillance.
Forekomsten af bekræftet hypoglykæmi var ikke almindelig med Onglyza 5 mg (0,8 %) og placebo (0,7 %). 
The incidence of confirmed hypoglycaemia was uncommon for Onglyza 5 mg (0.8%) and placebo (0.7%).
Andel af patienter, der opnåede HbA1c <7 % 
Proportion of patients achieving HbA1c < 7%
Saxagliptins sikkerhed og effekt som oral tripelbehandling med metformin og thiazolidindion er ikke fastslået. 
The safety and efficacy of saxagliptin as triple oral therapy in combination with metformin and a thiazolidinedione have not been established.
Efter 18 uger var saxagliptin non-inferior i forhold til sitagliptin, hvad angik gennemsnitlig reduktion fra baseline i HbA1c ved per-protokol-analysen og fuld analyse. 
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.
Føde har relativ beskeden effekt på saxagliptins farmakokinetik hos raske forsøgspersoner. 
Food had relatively modest effects on the pharmacokinetics of saxagliptin in healthy subjects.
Forsigtighed tilrådes, hvis Onglyza anvendes til patienter, som har kendte risikofaktorer for hospitalsindlæggelse for hjertesvigt, såsom hjertesvigt eller moderat til svært nedsat nyrefunktion, i anamnesen. 
Caution is warranted if Onglyza is used in patients who have known risk factors for hospitalisation for heart failure, such as a history of heart failure or moderate to severe renal impairment.
Der er ikke observeret nogen betydelig akkumulering af hverken saxagliptin eller hovedmetabolitten ved gentagne daglige engangsdoseringer på noget dosisniveau. 
No appreciable accumulation of either saxagliptin or its major metabolite was observed with repeated once-daily dosing at any dose level.
Et andet sekundært endepunkt, total mortalitet, forekom i en frekvens på 5,1 % i saxagliptingruppen og 4,6 % i placebogruppen (se tabel 4). 
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 4).
Det er ukendt, om saxagliptin udskilles i human mælk. 
It is unknown whether saxagliptin is excreted in human breast milk.
Onglyzas sikkerhed og virkning hos børn i alderen 0 måneder til < 18 år er endnu ikke klarlagt: Der foreligger ingen data. 
The safety and efficacy of Onglyza in children aged birth to < 18 years have not yet been established.
Saxagliptin absorberedes hurtigt efter oral administration i fastende tilstand og maksimale plasmakoncentrationer (Cmax) af saxagliptin og hovedmetabolitten opnåedes inden for henholdsvis 2 og 4 timer (Tmax). 
Saxagliptin was rapidly absorbed after oral administration in the fasted state, with maximum plasma concentrations (Cmax) of saxagliptin and its major metabolite attained within 2 and 4 hours (Tmax), respectively.
Onglyza indeholder mindre end 1 mmol natrium (23 mg) per dosis, dvs. den er i det væsentlige ”natriumfri”. 
Onglyza contains less than 1 mmol sodium (23 mg) per dose, i.e. is essentially ‘sodium-free'.
Nogle patienter har desuden haft følgende bivirkning, når de har taget Onglyza alene: • Almindelig: Svimmelhed, diarré og mavepine. 
Some patients have had the following additional side effects while taking Onglyza alone: • Common: dizziness, diarrhoea and stomach ache.
Den samlede bivirkningsfrekvens hos patienter, der blev behandlet med Onglyza i dette studie var sammenlignelig med den for placebo (henholdsvis 72,5 % versus 72,2 %). 
The overall incidence of adverse events in patients treated with Onglyza in this trial was similar to placebo (72.5% versus 72.2%, respectively).
• hvis du har nedsat nyrefunktion, vil din læge bestemme, om du skal tage en lavere dosis Onglyza. 
• if you have reduced kidney function, your doctor will decide if you need to take a lower dose of Onglyza.
Forekomsten af bekræftede hypoglykæmiske hændelser var noget højere i saxagliptin-gruppen (9,4 %) i forhold til placebogruppen (4,7 %), dog afveg antallet af forsøgspersoner med enhver form for hypoglykæmisk hændelse ikke mellem behandlingsgrupperne. 
The incidence of confirmed hypoglycaemic events was somewhat higher in the saxagliptin group (9.4%) versus placebo group (4.7%) although the number of subjects with any hypoglycaemic event did not differ between the treatment groups.
Hver tablet indeholder 99 mg lactose (som monohydrat). 
Each tablet contains 99 mg lactose (as monohydrate).
Dette er blodtrykssænkende medicin. 
This is a medicine used to lower blood pressure.
Ved mistanke om en alvorlig overfølsomhedsreaktion over for saxagliptin bør Onglyza seponeres, evaluer for andre mulige årsager til hændelsen og skift til anden antidiabetisk behandling (se pkt. 
If a serious hypersensitivity reaction to saxagliptin is suspected, Onglyza should be discontinued, assess for other potential causes for the event, and institute alternative treatment for diabetes (see section 4.8).
Onglyza indeholder: - Aktivt stof: Saxagliptin. 
What Onglyza contains - The active substance is saxagliptin.
Denne medicin indeholder mindre end 1 mmol natrium (23 mg) per dosis, dvs. den er i det væsentlige natriumfri. 
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say it is essentially ‘sodium-free'.
Farmakokinetikken for saxagliptin og hovedmetabolitten var sammenlignelige hos raske personer og patienter med type 2-diabetes. 
The pharmacokinetics of saxagliptin and its major metabolite were similar in healthy subjects and in patients with type 2 diabetes.
Mindste kvadraters metode justeret for baseline-værdier. 
Least squares mean adjusted for baseline value.
Efter en oral glucose-belastning resulterede denne DPP4-hæmning i en 2 til 3-fold stigning i de cirkulerende niveauer af aktive inkretinhormoner, inklusive glukagonlignende peptid-1 (GLP-1) og glucoseafhængigt insulinotropt polypeptid (GIP), et fald i glukagonkoncentrationer og øgning af den glucoseafhængige beta-cellereaktionsevne, hvilket resulterede i højere koncentrationer af insulin og C-peptid . 
After an oral glucose load, this DPP4 inhibition resulted in a 2- to 3-fold increase in circulating levels of active incretin hormones, including glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), decreased glucagon concentrations and increased glucose-dependent beta-cell responsiveness, which resulted in higher insulin and C-peptide concentrations.
Tiden for opnåelse af Cmax (Tmax) for saxagliptin blev øget med omtrent 0,5 time ved fødeindtagelse sammenlignet med fastende tilstand. 
The time for saxagliptin to reach Cmax (Tmax) was increased by approximately 0.5 hours with food compared with the fasted state.
Nogle patienter har haft en lille reduktion i antallet af en bestemt type hvide blodlegemer (lymfocytter) ved anvendelse af Onglyza alene eller sammen med andre lægemidler. 
Some patients have had a small reduction in the number of one type of white blood cells (lymphocytes) shown in a blood test when Onglyza was used alone or in combination.
Tilsvarende reduktion i HbA1c versus placebo blev opnået hos patienter, der fik saxagliptin 5 mg som tillæg til insulin uanset brug af metformin (-0,4 % for begge subgrupper). 
Similar HbA1c reductions versus placebo were achieved for patients receiving saxagliptin 5 mg add-on to insulin regardless of metformin use (−0.4% for both subgroups).
Hos de patienter, der blev behandlet med saxagliptin, sås en signifikant reduktion af kropsvægt fra baseline sammenlignet med en vægtøgning hos patienter, der fik glipizid (-1,1 vs. +1,1 kg). 
Patients treated with saxagliptin exhibited a significant decrease from baseline in body weight compared to a weight gain in patients administered glipizide (-1.1 vs. +1.1 kg).
Forbedringerne i HbA1c efter behandlingen med saxagliptin 2,5 mg var vedvarende frem til uge 52, men antallet af patienter, som gennemførte 52 ugers behandling uden justeringer af anden antihyperglykæmisk behandling, var lavt (26 forsøgspersoner i saxagliptin-gruppen over for 34 forsøgspersoner i placebogruppen). 
Improvements in HbA1c following treatment with saxagliptin 2.5 mg were sustained up to Week 52, however, the number of patients who completed 52 weeks without modification of other antihyperglycaemic treatment was low (26 subjects in the saxagliptin group versus 34 subjects in the placebo group).
Incidensen af diarré var 4,1 % (36/882) i den gruppe, der fik saxagliptin 5 mg, og 6,1 % (49/799) i den gruppe, der fik placebo. 
The incidence of diarrhoea was 4.1% (36/882) in the saxagliptin 5 mg group and 6.1% (49/799) in the placebo group.
Gennemsnitlige baseline HbA1c 
Mean baseline HbA1c
Hos cynomolgusaber medførte saxagliptin reversible hudlæsioner (sårskorper, sårdannelse og nekrose) i ekstremiteterne (hale, tæer/fingre, skrotum og/eller næse) ved doser ≥3 mg/kg/dag. 
In cynomolgus monkeys saxagliptin produced reversible skin lesions (scabs, ulcerations and necrosis) in extremities (tail, digits, scrotum and/or nose) at doses ≥ 3 mg/kg/day.
Onglyza må ikke anvendes til patienter, som har haft alvorlige overfølsomhedsreaktioner over for en dipeptidylpeptidase-4- (DPP-4-) hæmmer (se pkt. 
Onglyza must not be used in patients who have had any serious hypersensitivity reaction to a dipeptidyl peptidase-4 (DPP4) inhibitor (see section 4.3).
De gennemsnitlige terminale plasmahalveringstider (t1/2) for saxagliptin og hovedmetabolitten er 2,5 timer henholdsvis 3,1 timer og den gennemsnitlige t1/2 for inhibering af plasma-DPP4 var 26,9 timer. 
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.
• Ikke almindelig: Træthed, unormale lipid (fedtsyre)-niveauer (dyslipidæmi, hypertriglyceridæmi). 
• Uncommon: tiredness, abnormal lipid (fatty acids) levels (dyslipidaemia, hypertriglyceridaemia).
Ved initial kombination med metformin er myalgi indrapporteret med hyppigheden ikke almindelig. 
As initial combination with metformin, myalgia is reported as uncommon.
Tabletterne kan tages sammen med eller uden et måltid uafhængigt af tidspunktet på dagen. 
Method of administration The tablets can be taken with or without a meal at any time of the day.
MONOTERAPI STUDIER 
MONOTHERAPY STUDIES
I kliniske forsøg udført på raske forsøgspersoner blev hverken farmakokinetikken af saxagliptin eller dets hovedmetabolit betydeligt ændret af metformin, glibenclamid, pioglitazon, digoxin, simvastatin, omeprazol, antacida eller famotidin. 
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.
Studiepopulationen omfattede patienter ≥65 år (n=8.561) og ≥75 år (n=2.330) med normal eller let nedsat nyrefunktion (n=13.916), moderat (n=2.240) eller svært (n=336) nedsat nyrefunktion. 
The study population included those ≥65 years (n=8561) and ≥ 75 years (n=2330), with normal or mild renal impairment (n=13,916) as well as moderate (n=2240) or severe (n=336) renal impairment.
Undersøgelsen omfattede patienter med nedsat nyrefunktion, der blev klassificeret på baggrund af kreatinin-clearance som let (ca. GFR ≥ 45 til <90 ml/min), moderat (ca. GFR ≥ 30 til <45 ml/min ) eller svært nedsat (ca. GFR < 30 ml/min ) samt patienter med ESRD i hæmodialyse. 
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), as well as patients with ESRD on haemodialysis.
Saxagliptin med et thiazolidinedion 
Saxagliptin with a thiazolidinedione
Yderligere information om Onglyza findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu. 
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Nøgleresultater af effekten af Onglyza 5 mg dagligt i placebo-kontrollerede monoterapi-forsøg og i forsøg med tillægs-kombinationsbehandling 
Table 2 Key efficacy results of Onglyza 5 mg per day in placebo-controlled monotherapy trials and in add-on combination therapy trials
Farmakoterapeutisk klassifikation: Antidiabetika: Dipeptidylpeptidase-4- (DPP4-) hæmmere, ATC-kode: A10BH03 
Dipeptidyl peptidase 4 (DPP4) inhibitors, ATC code: A10BH03
Dosis skal reduceres til 2,5 mg én gang dagligt hos patienter med moderat nyrefunktion, som har GFR < 45 ml/min og hos patienter med svært nedsat nyrefunktion. 
The dose should be reduced to 2.5 mg once daily in patients with moderate renal impairment that have GFR < 45 mL/min and in patients with severe renal impairment.
Faldet i lymfocyttal var ikke associeret med klinisk relevante bivirkninger. 
The decreases in lymphocyte count were not associated with clinically relevant adverse reactions.
Cmax og AUC værdier for saxagliptin og hovedmetabolitten øgedes proportionalt med øgningerne i saxagliptin-dosis, og denne dosis-proportionalitet blev observeret i doser på op til 400 mg. 
The Cmax and AUC values of saxagliptin and its major metabolite increased proportionally with the increment in the saxagliptin dose, and this dose-proportionality was observed in doses up to 400 mg.
Det er ingen anbefalinger om dosisjusteringer hos patienter med let nedsat nyrefunktion eller hos patienter med moderat nedsat nyrefunktion, som har GFR ≥ 45 ml/min.. 
No dose adjustment is recommended for patients with mild renal impairment or in patients with moderate renal impairment that have GFR ≥ 45 mL/min.
Efter en enkeltdosis på 50 mg C-saxagliptin, blev henholdsvis 24 %, 36 % og 75 % af dosis udskilt i urinen som saxagliptin, som hovedmetabolitten og som total radioaktivitet. 
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.
De hyppigst indberettede bivirkninger i placebokontrollerede forsøg, som er indrapporteret hos ≥ 5 % af de patienter, der blev behandlet med Onglyza 5 mg, og hyppigere end hos de patienter, der blev behandlet med placebo, er øvre luftvejsinfektion (7,7 %), urinvejsinfektion (6,8 %) og hovedpine (6,5 
The most commonly reported adverse reactions in placebo-controlled trials reported in ≥5% of patients treated with Onglyza 5 mg and more commonly than in patients treated with placebo are upper respiratory tract infection (7.7%), urinary tract infection (6.8%) and headache (6.5%).
Hos patienter med mild (Child-Pugh Class A), moderat (Child-Pugh Class B) eller svært (Child-Pugh Class C) nedsat leverfunktion var eksponeringen af saxagliptin henholdsvis 1,1-, 1,4.- og 1,8-fold højere og eksponeringen af BMS-510849 var henholdsvis 22 %, 7 % og 33 % lavere end hos de observerede raske personer. 
In subjects with mild (Child-Pugh Class A), moderate (Child-Pugh Class B), or severe (Child-Pugh Class C) hepatic impairment the exposures to saxagliptin were 1.1-, 1.4- and 1.8-fold higher, respectively, and the exposures to BMS-510849 were 22%, 7%, and 33% lower, respectively, than those observed in healthy subjects.
Samtidig administration af saxagliptin og CYP3A4/5-inducere, andre end rifampicin, (så som carbamazepin, dexamethason, phenobarbital og fenytoin) er ikke blevet undersøgt og kan muligvis resultere i nedsat plasmakoncentration af saxagliptin og øget koncentration af dets hovedmetabolit. 
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.
Der er ikke observeret nogen dosis- eller tidsafhængighed i clearance af saxagliptin eller hovedmetabolitten i løbet af 14 dages daglig engangsdosering med saxagliptin i doser fra 2,5 mg til 400 mg. 
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.
Efter en 5 mg oral enkeltdosis saxagliptin hos raske forsøgspersoner, var de gennemsnitlige plasma AUC-værdier for saxagliptin og hovedmetabolitten henholdsvis 78 ng·h/ml og 214 ng·h/ml. 
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.
Nuleffekts-dosis (NOEL) for læsioner er 1 og 2 gange den humane eksponering af saxagliptin henholdsvis hovedmetabolitten ved den anbefalede humane dosis på 5 mg/dag (RHD). 
The no effect level (NOEL) for the lesions is 1 and 2 times the human exposure of saxagliptin and the major metabolite respectively, at the recommended human dose of 5 mg/day (RHD).
Den samlede forekomst af rapporteret hypoglykæmi (registreret i daglige patientdagbøger) var 17,1 % hos forsøgspersoner, der blev behandlet med Onglyza, og 14,8 % hos patienter, der fik placebo. 
The overall incidence of reported hypoglycaemia (recorded in daily patient diaries) was 17.1% in subjects treated with Onglyza and 14.8% among patients treated with placebo.
To dobbelt-blinde, placebo-kontrollerede studier af 24-ugers varighed blev udført for at vurdere effekt og sikkerhed af saxagliptin monoterapi hos patienter med type 2-diabetes. 
Two double-blind, placebo-controlled studies of 24-week duration were conducted to evaluate the efficacy and safety of saxagliptin monotherapy in patients with type 2 diabetes.
Derudover ændrede saxagliptin ikke farmakokinetikken af metformin, glibenclamid, pioglitazon, digoxin, simvastatin, de aktive stoffer (ethinylestradiol og norgestimat) i orale kontraceptiva af kombinationstypen, diltiazem eller ketoconazol. 
In addition, saxagliptin did not meaningfully alter the pharmacokinetics of metformin, glibenclamide, pioglitazone, digoxin, simvastatin, the active components of a combined oral contraceptive (ethinyl estradiol and norgestimate), diltiazem or ketoconazole.
Når Onglyza gives i kombination med insulin eller sulfonylurinstof, vil en lavere dosis af insulin eller sulfonylurinstof muligvis være påkrævet for at nedsætte risikoen for hypoglykæmi (se pkt. 
When Onglyza is used in combination with insulin or a sulphonylurea, a lower dose of the insulin or sulphonylurea may be required to reduce the risk of hypoglycaemia (see section 4.4).
Lavt blodsukker (hypoglykæmi) kan påvirke evnen til at færdes sikkert i trafikken og betjene maskiner eller arbejde med sikkert fodfæste, og der er risiko, at du får for lavt blodsukker, hvis du tager denne medicin sammen med medicin, der er kendt for at medføre lavt blodsukker, som for eksempel insulin og sulfonylurinstoffer. 
Hypoglycaemia may affect your ability to drive and use machines or work with safe foothold and there is a risk of hypoglycaemia when taking this medicine in combination with medicines known to cause hypoglycaemia such as insulin and sulphonylureas.
Lactosemonohydrat Cellulose, mikrokrystallinsk (E460i) Croscarmellosenatrium (E468) Magnesiumstearat 
Lactose monohydrate Cellulose, microcrystalline (E460i) Croscarmellose sodium (E468) Magnesium stearate
Cmax og AUC for saxagliptin og hovedmetabolitten stiger proportionalt med dosis af saxagliptin. 
The Cmax and AUC of saxagliptin and its major metabolite increased proportionally to the saxagliptin dose.
Saxagliptin i kombination med en fastsat, midlertidig dosis af sulfonylurinstof (glibenclamid 7,5 mg) blev sammenlignet med titrering op til en højere dosis af glibenclamid (omkring 92 % af patienterne i placebo + glibenclamid gruppen blev optitreret til endelig daglig totaldosis på 15 mg). 
Saxagliptin in combination with a fixed, intermediate dose of a sulphonylurea (glibenclamide 7.5 mg) was compared to titration to a higher dose of glibenclamide (approximately 92% of patients in the placebo plus glibenclamide group were uptitrated to a final total daily dose of 15 mg).
‡ p <0,001 for noninferioritet (baseret på HR <1,3) sammenlignet med placebo. 
p-value <0.001 for noninferiority (based on HR <1.3) compared to placebo.
Saxagliptin er en højpotent (Ki: 1.3 nM), selektiv, reversibel, kompetitiv, DPP4-hæmmer. 
Mechanism of action and pharmacodynamic effects Saxagliptin is a highly potent (Ki: 1.3 nM), selective, reversible, competitive, DPP4 inhibitor.
Et åbent, enkelt-dosis studie blev gennemført for at evaluere farmakokinetikken af en 10 mg oral dosis saxagliptin hos forsøgspersoner med forskellig grad af kronisk nedsat nyrefunktion sammenlignet med forsøgspersoner med normal nyrefunktion. 
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.
Sikkerhedsprofilen af saxagliptin i tillæg til dapagliflozin og metformin i den langsigtede behandlingsperiode var i overensstemmelse med det, der blev observeret i 24 ugers behandlingsperioden i dette studie, og i studiet hvor saxagliptin og dapagliflozin blev givet til patienterne samtidig i tillæg til behandling med metformin (beskrevet nedenfor). 
The safety profile of saxagliptin added to dapagliflozin plus metformin in the long-term treatment period was consistent with that observed in the 24-week treatment period in this study and in the trial in which saxagliptin and dapagliflozin were given concomitantly as add-on therapy to patients treated with metformin (described below).
Ved brug af CYP3A4-inducere såsom carbamazepin, dexamethason, phenobarbital, phenytoin og rifampicin kan Onglyzas glykæmisk sænkende effekt blive reduceret (se pkt. 
Using CYP3A4 inducers like carbamazepine, dexamethasone, phenobarbital, phenytoin, and rifampicin may reduce the glycaemic lowering effect of Onglyza (see section 4.5).
Biotransformationen af saxagliptin medieres primært af cytochrom P450 3A4/5 (CYP3A4/5). 
The biotransformation of saxagliptin is primarily mediated by cytochrome P450 3A4/5 (CYP3A4/5).