natgillin/translations-raw huggingface dataset:
Treatment with vildagliptin 50-100 mg daily in patients with type 2 diabetes significantly improved markers of beta cell function including HOMA- (Homeostasis Model Assessment-), proinsulin to insulin ratio and measures of beta cell responsiveness from the frequently-sampled meal tolerance test. 
Zdravljenje z vildagliptinom v odmerkih 50-100 mg dnevno je pri bolnikih z diabetesom tipa 2 pomembno izboljšalo vrednosti kazalcev delovanja beta celic, vključno z modelom ocene homeostaze HOMA-β, razmerjem med proinsulinom in insulinom ter merjenjem odzivnosti beta celic po obroku s pogostim vzorčenjem.
Glucagon triggers the liver to make sugar, causing the blood sugar level to rise. 
Glukagon sproži tvorbo sladkorja v jetrih in tako povzroči zviševanje koncentracije sladkorja v krvi.
Two patients reported severe hypoglycaemic events in the vildagliptin group, and 6 patients in the placebo group. 
O epizodah hude hipoglikemije sta v skupini z vildagliptinom poročala dva bolnika, v skupini s placebom pa je o tem poročalo 6 bolnikov.
Vildagliptin acts primarily by inhibiting DPP-4, the enzyme responsible for the degradation of the incretin hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic polypeptide). 
Vildagliptin deluje predvsem z zaviranjem DPP-4, encima, ki je odgovoren za razgradnjo hormonov inkretinov GLP-1 (glukagonu podoben peptid 1) in GIP (od glukoze odvisni insulinotropni polipeptid).
The majority of adverse reactions were mild and transient, not requiring treatment discontinuations. 
Neželeni učinki so bili večinoma blagi in prehodne narave, zdravljenja zaradi njih ni bilo treba prekinjati.
If necessary, the dosage of Zomarist may need to be adjusted during concomitant therapy and on its discontinuation. 
Če je potrebno, je mogoče prilagoditi odmerek zdravila Zomarist v času sočasne uporabe drugega zdravila in ob njegovi ukinitvi.
Your doctor will decide when you must stop and when to restart your treatment with Zomarist. 
Zdravnik se bo odločil, kdaj morate z jemanjem zdravila Zomarist prenehati in kdaj lahko nadaljujete.
• Frequency not known (cannot be estimated from the available data): itchy rash, inflammation of the pancreas, localised peeling of skin or blisters, muscle pain. 
• neznana pogostnost (je ni mogoče oceniti iz razpoložljivih podatkov): srbeč izpuščaj, vnetje trebušne slinavke, lokalizirano luščenje kože ali mehurji, bolečina v mišicah.
Hepatic impairment: In subjects with mild, moderate or severe hepatic impairment (Child-Pugh A-C) there were no clinically significant changes (maximum ~30%) in exposure to vildagliptin. 
Okvara jeter: Pri bolnikih z blago, zmerno in hudo okvaro jeter (razredi A do C po Child-Pughovi lestvici) ni prišlo do klinično pomembnih sprememb izpostavljenosti vildagliptinu (največ ~30 %).
Zomarist should not be used in patients with hepatic impairment, including those with pre-treatment alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 times the upper limit of normal (ULN) (see sections 4.3, 4.4 and 4.8). 
Zdravila Zomarist ne smejo uporabljati bolniki z okvaro jeter, vključno z bolniki, ki imajo pred zdravljenjem vrednosti alanin-aminotransferaze (ALT) ali aspartat-aminotransferaze (AST) nad 3-kratno zgornjo mejo normalnih vrednosti (upper limit of normal - ULN) (glejte poglavja 4.3, 4.4 in
As metformin is excreted via the kidney, and elderly patients have a tendency to decreased renal function, elderly patients taking Zomarist should have their renal function monitored regularly (see sections 4.4 and 5.2). 
Metformin se izloča preko ledvic, pri starejših bolnikih pa je delovanje ledvic pogosto zmanjšano, zato je treba starejšim bolnikom, ki jemljejo zdravilo Zomarist, redno pregledovati delovanje ledvic (glejte poglavji 4.4 in 5.2).
Metformin stimulates intracellular glycogen synthesis by acting on glycogen synthase and increases the transport capacity of specific types of membrane glucose transporters (GLUT-1 and GLUT-4). 
Metformin z delovanjem na glikogen-sintazo spodbuja znotrajcelično tvorbo glikogena, poleg tega pa povečuje transportno zmožnost specifičnih vrst membranskih glukoznih prenašalcev (GLUT-1 in GLUT-4).
Skin lesions were not reversible in the monkeys treated at 160 mg/kg/day during a 4-week recovery period. 
Pri opicah, ki so prejemale 160 mg/kg/dan, kožne lezije niso bile reverzibilne v 4-tedenskem obdobju okrevanja.
Drug-drug interaction studies with digoxin (P-glycoprotein substrate) and warfarin (CYP2C9 substrate) in healthy subjects have shown no clinically relevant pharmacokinetic interactions after coadministration with vildagliptin. 
Študije medsebojnega delovanja z digoksinom (substratom P-glikoproteina) in z varfarinom (substratom CYP2C9) na zdravih prostovoljcih niso pokazale nobenih klinično pomembnih farmakokinetičnih interakcij pri sočasni uporabi vildagliptina.
What Zomarist contains - The active substances are vildagliptin and metformin hydrochloride. 
Kaj vsebuje zdravilo Zomarist - Učinkovini sta vildagliptin in metforminijev klorid.
If necessary, the dosage of the antihyperglycaemic medicinal product should be adjusted during therapy with the other medicinal product and on its discontinuation. 
Kadar je to potrebno, je treba med zdravljenjem z drugim zdravilom ali ob njegovi ukinitvi prilagajati odmerjanje antihiperglikemičnega zdravila.
At 600 mg, one subject experienced oedema of the feet and hands, and increases in creatine phosphokinase (CPK), AST, C-reactive protein (CRP) and myoglobin levels. 
Pri 600 mg je pri eni osebi prišlo do otekanja rok in stopal ter zvišanja koncentracij kreatin-kinaze (CK), aspartataminotransferaze (AST), C-reaktivnega proteina (CRP) in mioglobina.
The incidence of hypoglycaemia was significantly lower in the vildagliptin group (1.7%) than in the glimepiride group (16.2%). 
V skupini z vildagliptinom je bila incidenca hipoglikemije bistveno nižja (1,7 %) kot v skupini z glimepiridom (16,2 %).
In non-diabetic (normal glycaemic) individuals, vildagliptin does not stimulate insulin secretion or reduce glucose levels. 
Pri osebah brez diabetesa (z normalnimi koncentracijami glukoze v krvi) vildagliptin ne spodbuja izločanja insulina in ne znižuje koncentracije glukoze.
Metformin acts primarily by decreasing endogenous hepatic glucose production. 
Metformin deluje predvsem tako, da zmanjšuje endogeno tvorbo glukoze v jetrih.
Following oral administration in the fasting state, vildagliptin is rapidly absorbed with peak plasma concentrations observed at 1.7 hours. 
Po peroralni aplikaciji na tešče se vildagliptin hitro absorbira in doseže najvišje koncentracije v plazmi po 1,7 ure.
No studies on the effect on human fertility have been conducted for Zomarist (see section 5.3). 
Študij o vplivu zdravila Zomarist na plodnost pri ljudeh niso izvajali (glejte poglavje 5.3).
The composite endpoint of adjudicated major adverse cardiovascular events (MACE) including acute myocardial infarction, stroke or cardiovascular death was similar for vildagliptin versus combined active and placebo comparators [Mantel-Haenszel risk ratio (M-H RR) 0.82 (95% CI 0.61-1.11)]. 
Rezultati pri sestavljenem cilju opazovanja, ki je obsegal dogodke, ocenjene kot pomembne neželene kardiovaskularne dogodke (MACE - major adverse cardiovascular events), ki vključujejo akutni miokardni infarkt, možgansko kap ali kardiovaskularno smrt, so bili pri uporabi vildagliptina podobni kot pri uporabi aktivnih primerjalnih zdravil oziroma placeba [razmerje tveganj po MantelHaenszelovi metodi (M-H RR) 0,82 (95-odstotni interval zaupanja 0,61-1,11)].
In these studies, no clinically relevant pharmacokinetic interactions were observed after co-administration with vildagliptin. 
V teh študijah niso opažali nobenih klinično pomembnih farmakokinetičnih interakcij pri sočasni uporabi vildagliptina.
After intravenous administration to healthy subjects, the total plasma and renal clearances of vildagliptin are 41 and 13 l/h, respectively. 
Po intravenski aplikaciji zdravim osebam je znašal celotni plazemski očistek vildagliptina 41 l/h, ledvični očistek pa 13 l/h.
The data presented here relate to the co-administration of vildagliptin and metformin, where vildagliptin has been added to metformin. 
Navedeni podatki se nanašajo na sočasno uporabo vildagliptina in metformina, pri čemer so vildagliptin dodali metforminu.
The incidence of hypoglycaemia was similar in both treatment groups (14.0% in the vildagliptin group vs 16.4% in the placebo group). 
Pogostost hipoglikemije je bila v obeh zdravljenih skupinah podobna (14,0 % v skupini z vildagliptinom v primerjavi s 16,4 % v skupini s placebom).
The most effective method of removing metformin is haemodialysis. 
Hemodializa je najučinkovitejši način odstranjevanja metformina.
Should an increase in AST or in ALT of 3x ULN or greater persist, withdrawal of Zomarist therapy is recommended. 
Če zvišanje AST ali ALT na ali nad 3-kratno zgornjo mejo normalnih vrednosti (ULN - upper limit of normal) vztraja, je priporočena prekinitev zdravljenja z zdravilom Zomarist.
It does not stimulate insulin secretion and therefore does not produce hypoglycaemia or increased weight gain. 
Metformin ne spodbuja sekrecije insulina in zato ne povzroča hipoglikemije ali povečanja telesne mase.
Analysis of the results for overweight patients treated with metformin after failure of diet alone showed: - a significant reduction in 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 patientyears), 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 in the absolute risk of 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 in 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 patientyears (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). 
Za bolnike s prekomerno telesno maso, ki so bili zdravljeni z metforminom po neuspešnem zdravljenju samo z dieto, je analiza rezultatov pokazala: - pomembno zmanjšanje absolutnega tveganja za katerikoli diabetični zaplet v skupini z metforminom (29,8 dogodkov/1.000 bolnikov-let) v primerjavi s skupino bolnikov, zdravljenih samo z dieto (43,3 dogodkov/1.000 bolnikov-let), p=0,0023, in v primerjavi z združeno skupino bolnikov, zdravljenih samo s sulfonilureo, in bolnikov, zdravljenih samo z insulinom (40,1 dogodek/1.000 bolnikov-let), p=0,0034; - pomembno zmanjšanje absolutnega tveganja za umrljivost, povezano z diabetesom: metformin 7,5 dogodkov /1.000 bolnikov-let, samo dieta: 12,7 dogodkov/1.000 bolnikov-let, p=0,017; - pomembno zmanjšanje absolutnega tveganja za splošno umrljivost: skupina z metforminom 13,5 dogodkov/1.000 bolnikov-let v primerjavi s skupino bolnikov, zdravljenih samo z dieto, 20,6 dogodkov /1.000 bolnikov-let (p=0,011) in v primerjavi z združeno skupino bolnikov, zdravljenih samo s sulfonilureo, in bolnikov, zdravljenih samo z insulinom, 18,9 dogodkov/1.000 bolnikov-let (p=0,021); - pomembno zmanjšanje absolutnega tveganja za miokardni infarkt: metformin 11 dogodkov/1.000 bolnikov-let, samo dieta 18 dogodkov/1.000 bolnikov-let (p=0,01).
Symptoms of lactic acidosis include: - vomiting - stomach ache (abdominal pain) - muscle cramps - a general feeling of not being well with severe tiredness - difficulty in breathing - reduced body temperature and heartbeat 
Simptomi laktacidoze vključujejo: bruhanje bolečina v trebuhu (abdominalna bolečina) mišične krče splošno slabo počutje s hudo utrujenostjo težave z dihanjem znižano telesno temperaturo in počasen srčni utrip
No dose adjustment. 
Prilagajanje odmerka ni potrebno.
Zomarist with alcohol 
Zdravilo Zomarist skupaj z alkoholom
Zomarist is indicated in the treatment of type 2 diabetes mellitus: - Zomarist is indicated in the treatment of adult patients who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone or who are already treated with the combination of vildagliptin and metformin as separate tablets. 
Zdravilo Zomarist je indicirano za zdravljenje bolnikov z diabetesom tipa 2: - Zdravilo Zomarist je indicirano za zdravljenje odraslih bolnikov, pri katerih diabetesa ni mogoče urediti samo z metforminom v največjem peroralnem odmerku, ki ga še prenašajo, ali pri tistih, ki že prejemajo zdravljenje z vildagliptinom in metforminom v obliki ločenih tablet.
• Very rare (may affect up to 1 in 10,000 people): sore throat, runny nose, fever; signs of a high level of lactic acid in the blood (known as lactic acidosis) such as drowsiness or dizziness, severe nausea or vomiting, abdominal pain, irregular heart beat or deep, rapid breathing; redness of the skin, itching; decreased vitamin B12 levels (paleness, tiredness, mental symptoms such as confusion or memory disturbances). 
• Zelo redki (pojavijo se lahko pri največ 1 od 10.000 bolnikov): boleče grlo, nahod, zvišana telesna temperatura, znaki visoke koncentracije mlečne kisline v krvi (kar imenujemo laktacidoza), kot so dremavost ali omotičnost, huda slabost ali bruhanje, bolečine v trebuhu, neredno bitje srca ali globoko hitro dihanje, rdečina kože, srbenje, znižane vrednosti vitamina B12 (bledica, utrujenost, psihični simptomi, kot sta zmedenost ali motnje spomina).
A greater proportion of cases were reported when vildagliptin was administered in combination with an ACE inhibitor. 
O večjem deležu primerov so poročali ob jemanju vildagliptina v kombinaciji z zaviralcem angiotenzinske konvertaze (zaviralcem ACE).
• Very common (may affect more than 1 in 10 people): nausea, vomiting, diarrhoea, pain in and around the stomach (abdominal pain), loss of appetite. 
• Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov): slabost, bruhanje, driska, bolečina v želodcu in okrog njega (bolečine v trebuhu), izguba apetita.
The administration of vildagliptin results in a rapid and complete inhibition of DPP-4 activity resulting in increased fasting and postprandial endogenous levels of the incretin hormones GLP-1 and GIP. 
Uporaba vildagliptina povzroči hitro in popolno zaviranje delovanja DPP-4, kar povzroča zvišanje endogenih koncentracij hormonov inkretinov GLP-1 in GIP na tešče in po obroku.
Vildagliptin added to patients whose glycaemic control was not satisfactory despite treatment with metformin monotherapy resulted after 6-month treatment in additional statistically significant mean reductions in HbA1c compared to placebo (between group differences of -0.7% to -1.1% for vildagliptin 50 mg and 100 mg, respectively). 
Vildagliptin, ki so ga dodajali bolnikom, pri katerih glikemija ni bila zadovoljivo urejena kljub zdravljenju z metforminom v monoterapiji, je po 6-mesečnem zdravljenju povzročil dodatno statistično značilno povprečno znižanje HbA1c v primerjavi s placebom (razlika med skupinama -0,7 % za odmerek 50 mg vildagliptina in -1,1 % za odmerek 100 mg vildagliptina).
Some medicinal products can adversely affect renal function which may increase the risk of lactic acidosis, e.g. NSAIDs, including selective cyclo-oxygenase (COX) II inhibitors, ACE inhibitors, angiotensin II receptor antagonists and diuretics, especially loop diuretics. 
Kombinacije, pri katerih so potrebni previdnostni ukrepi Nekatera zdravila lahko škodljivo vplivajo na delovanje ledvic, kar lahko poveča tveganje za laktacidozo, npr. nesteroidna protivnetna zdravila, vključno s selektivnimi zaviralci ciklooksigenaze (COX) II, zaviralci ACE, antagonisti receptorjev angiotenzina II in diuretiki, zlasti diuretiki Henlejeve zanke.
See section 4 
Glejte poglavje 4.
Combinations not recommended 
Sočasna uporaba ni priporočljiva
Film-coated tablet. 
Filmsko obložena tableta.
Clinical trials of up to 2 years' duration did not show any additional safety signals or unforeseen risks with vildagliptin monotherapy. 
Klinična preskušanja, ki so trajala tudi do 2 leti, niso pri zdravljenju z vildagliptinom v monoterapiji pokazala nobenih dodatnih signalov glede varnosti ali nepredvidenega tveganja.
Additional information on the individual active substances of the fixed combination 
Dodatni podatki o posamezni učinkovini fiksne kombinacije Vildagliptin
If you need to have major surgery you must stop taking Zomarist during and for some time after the procedure. 
Če morate na večji kirurški poseg, morate v času posega in še nekaj časa po tem prenehati z jemanjem zdravila Eucras.
Confirmed heart failure (HF) events defined as HF requiring hospitalisation or new onset of HF were reported in 41 (0.43%) vildagliptin-treated patients and 32 (0.45%) comparator-treated patients with M-H RR 1.08 (95% CI 0.68-1.70). 
O potrjenih dogodkih v povezavi s srčnim popuščanjem, ki so bili opredeljeni kot srčno popuščanje, zaradi katerega mora biti bolnik sprejet v bolnišnico, ali pojav srčnega popuščanja na novo, so poročali pri 41 (0,43 %) bolnikih, ki so prejemali vildagliptin, in pri 32 (0,45 %) bolnikih, ki so prejemali katero od primerjalnih zdravil, z razmerjem M-H RR 1,08 (95-odstotni interval zaupanja 0,68-1,70).
Patients who develop jaundice or other signs suggestive of liver dysfunction should discontinue Zomarist. 
Bolniki, pri katerih pride do ikterusa ali drugih znakov, ki nakazujejo moteno delovanje jeter, morajo prekiniti zdravljenje z zdravilom Zomarist.
In a 13-week toxicology study in cynomolgus monkeys, skin lesions have been recorded at doses ≥ 5 mg/kg/day. 
V 13-tedenski toksikološki študiji na opicah (vrste javanski makak) so zabeležili kožne spremembe pri odmerkih ≥ 5 mg/kg/dan.
- For patients switching from co-administration of vildagliptin and metformin as separate tablets: Zomarist should be initiated at the dose of vildagliptin and metformin already being taken. 
- Za bolnike, ki prehajajo s sočasne uporabe vildagliptina in metformina v obliki ločenih tablet: Zdravilo Zomarist naj jemljejo v odmerku, ki ustreza dotedanjima odmerkoma vildagliptina in metformina.
Liver enzyme monitoring 
Spremljanje jetrnih testov
Your doctor may want to reduce your dose of the sulphonylurea when you take it together with Zomarist in order to avoid low blood glucose (hypoglycaemia). 
Zdravnik vam bo morda znižal odmerek sulfoniluree, ki jo boste jemali poleg zdravila Zomarist, da ne bi prišlo do zelo nizkih vrednosti glukoze v krvi (hipoglikemija).
Renal excretion of the unchanged vildagliptin accounted for 23% of the dose after oral administration. 
Po peroralni aplikaciji je izločanje nespremenjenega vildagliptina preko ledvic predstavljalo 23 % odmerka.
The decrease in HbA1c observed in patients with a baseline ≥10.0% was greater. 
Pri bolnikih z izhodiščno vrednostjo HbA1c ≥10,0% so opažali večje znižanje vrednosti HbA1c.
• Angioedema (rare: may affect up to 1 in 1,000 people): Symptoms include swollen face, tongue or throat, difficulty swallowing, difficulty breathing, sudden onset of rash or hives, which may indicate a reaction called “angioedema”. 
• angioedem (redek: pojavi se lahko pri največ 1 od 1.000 bolnikov): simptomi vključujejo otečen obraz, jezik ali grlo in žrelo, oteženo požiranje, oteženo dihanje, nenaden izbruh izpuščaja ali koprivnice, kar lahko kaže na reakcijo imenovano “angioedem”;
Vildagliptin in combination with insulin significantly decreased HbA1c compared with placebo. 
Vildagliptin je v kombinaciji z insulinom statistično značilno znižal vrednost HbA1c v primerjavi s placebom.
In these cases, the patients were generally asymptomatic without clinical sequelae and liver function tests (LFTs) returned to normal after discontinuation of treatment. 
V teh primerih bolniki večinoma niso imeli niti simptomov niti kliničnih posledic, izvidi jetrnih testov pa so se ponovno normalizirali po prekinitvi zdravljenja.
Vildagliptin in combination with metformin and glimepiride significantly decreased HbA1c compared with placebo. 
Vildagliptin je v kombinaciji z metforminom in glimepiridom statistično značilno znižal vrednost HbA1c v primerjavi s placebom.
Cationic active substances that are eliminated by renal tubular secretion (e.g. cimetidine) may interact with metformin by competing for common renal tubular transport systems and hence delay the elimination of metformin, which may increase the risk of lactic acidosis. 
S kationskimi zdravilnimi učinkovinami, ki se izločajo preko ledvic s tubulno sekrecijo (npr. s cimetidinom), lahko pride do medsebojnega delovanja z metforminom zaradi kompeticije za ledvične tubulne transportne sisteme, kar lahko povzroči upočasnjeno izločanje metformina, to pa lahko poveča tveganje za laktacidozo.
Patients receiving vildagliptin experienced no weight gain (+0.2 kg) while those receiving placebo experienced weight reduction (-0.7 kg). 
Pri bolnikih, ki so prejemali vildagliptin, ni prišlo dopovečanja telesne mase (+ 0,2 kg), pri tistih, ki so prejemali placebo, pa je prišlo do zmanjšanja telesne mase (- 0,7 kg).
• Inflammation of the pancreas (pancreatitis) (frequency not known): Symptoms include severe and persistent pain in the abdomen (stomach area), which might reach through to your back, as well as nausea and vomiting. 
• vnetje trebušne slinavke (pankreatitis) (pogostnost neznana): simptomi vključujejo hudo in trdovratno bolečino v trebuhu (v predelu želodca), ki lahko seva nazaj proti hrbtu, ter občutek slabosti (navzeo) in bruhanje.
Post-marketing experience 
Obdobje trženja
Decrease of vitamin B12 absorption and lactic acidosis* 
Presnovne in prehranske motnje zelo redki zmanjšanje absorpcije vitamina B12 in laktacidoza*
The incidence of hypoglycaemia was lower in the vildagliptin group than in the placebo group (22.9% vs. 29.6%). 
Pogostnost hipoglikemij je bila manjša v skupini z vildagliptinom kot v skupini s placebom (22,9 % v primerjavi z 29,6 %).
The recommended dose is one film-coated tablet of either 50 mg/850 mg or 50 mg/1000 mg taken twice a day 
Priporočeni odmerek je ena filmsko obložena tableta bodisi jakosti 50 mg/850 mg ali 50 mg/1000 mg dvakrat na dan.
For metformin, studies in animals have not shown reproductive toxicity. 
Za metformin študije na živalih niso pokazale vpliva na sposobnost razmnoževanja.
The proportion of patients who achieved a decrease in HbA1c of ≥ 0.7% from baseline was statistically significantly higher in both vildagliptin plus metformin groups (46% and 60%, respectively) versus the metformin plus placebo group (20%). 
Delež bolnikov, pri katerih je prišlo do znižanja HbA1c za ≥ 0,7 % od izhodiščne vrednosti, je bil v obeh skupinah s kombinacijo vildagliptina in metformina statistično značilno večji (46 % oziroma 60 %) v primerjavi s skupino, ki je prejemala metformin in placebo (20 %).
In another 24-week study in patients with more advanced type 2 diabetes not adequately controlled on insulin (short and longer acting, average insulin dose 80 IU/day), the mean reduction in HbA1c when vildagliptin (50 mg twice daily) was added to insulin was statistically significantly greater than with placebo plus insulin (0.5% vs. 0.2%). 
V drugi 24-tedenski študiji pri bolnikih z napredovalim diabetesom tipa 2, ki ni bil ustrezno urejen z insulinom (kratkodelujočim in dolgodelujčim, s povprečnim odmerkom insulina 80 i.e. na dan), je bilo povprečno znižanje vrednosti HbA1c pri dodatku vildagliptina (v odmerku 50 mg dvakrat na dan) statistično značilno večje kot pri uporabi placeba poleg insulina (0,5 % v primerjavi z 0,2 %).
LFTs should be performed prior to the initiation of treatment with Zomarist in order to know the patient's baseline value. 
Pred začetkom zdravljenja z zdravilom Zomarist je treba opraviti pregled jetrnih testov za določitev bolnikovih izhodiščnih vrednosti.
How Zomarist works 
Kako zdravilo Zomarist deluje