natgillin/translations-raw huggingface dataset:
In clinical studies, sitagliptin did not meaningfully alter the pharmacokinetics of metformin, glyburide, simvastatin, rosiglitazone, warfarin, or oral contraceptives, providing in vivo evidence of a low propensity for causing interactions with substrates of CYP3A4, CYP2C8, CYP2C9, and organic cationic transporter (OCT).
V klini nih študijah sitagliptin ni pomembneje spremenil farmakokinetike metformina, gliburida, simvastatina, rosiglitazona, varfarina ali peroralnih kontraceptivov, kar daje in vivo dokaz za majhno dovzetnost za medsebojno delovanje s substrati za CYP3A4, CYP2C8, CYP2C9 in prenašalci organskih kationov.
Sitagliptin had a small effect on plasma digoxin concentrations, and may be a mild inhibitor of p- glycoprotein in vivo.
Sitagliptin ima majhen u inek na koncentracije digoksina v plazmi in je in vivo lahko blagi zaviralec p- glikoproteina.
Sitagliptin had a small effect on plasma digoxin concentrations.
Sitagliptin ima majhen u inek na koncentracije digoksina v plazmi.
Following administration of 0.25 mg digoxin concomitantly with 100 mg of TESAVEL daily for 10 days, the plasma AUC of digoxin was increased on average by 11%, and the plasma Cmax on average by 18%.
Po 10- dnevnem dajanju digoksina v odmerku 0, 25 mg skupaj z zdravilom TESAVEL v odmerku 100 mg na dan sta se vrednosti AUC in Cmax digoksina v plazmi pove ale, in sicer AUC za približno 11%, Cmax pa za približno 18%.
However, patients at risk of digoxin toxicity should be monitored for this when sitagliptin and digoxin are administered concomitantly.
Prilagajanja odmerka digoksina ne priporo amo, vendar pa je bolnike s tveganjem za pojav toksi nosti digoksina med so asnim zdravljenjem s sitagliptinom in digoksinom treba nadzorovati.
Pregnancy There are no adequate data from the use of TESAVEL in pregnant women.
Nose nost Ni zadostnih podatkov o uporabi zdravila TESAVEL pri nose nicah.
Due to lack of human data, TESAVEL should not be used during pregnancy.
Zaradi pomanjkanja podatkov pri ljudeh se zdravilo TESAVEL med nose nostjo ne sme uporabljati.
Lactation It is unknown whether sitagliptin is excreted in human breast milk.
4 Dojenje Ni znano, e se sitagliptin izlo a v materino mleko pri ljudeh.
Animal studies have shown excretion of sitagliptin in breast milk.
Študije na živalih so pokazale, da se sitagliptin izlo a z mlekom.
TESAVEL should not be used during breast-feeding.
Med dojenjem se zdravilo TESAVEL ne sme uporabljati.
However, when driving or operating machines, it should be taken into account that dizziness and somnolence have been reported.
Študij o vplivu na sposobnost vožnje in upravljanja s stroji niso izvedli, vendar pa je pri vožnji ali upravljanju s stroji treba upoštevati, da so poro ali o pojavu omotice in zaspanosti.
4 4.8 Undesirable effects
4. 8 Neželeni u inki
In 9 large clinical trials of up to 2 years in duration, over 2700 patients have received treatment with TESAVEL 100 mg per day alone or in combination with metformin, a sulphonylurea (with or without metformin) or a PPARγ agent.
Med 9 obsežnimi klini nimi preskušanji, ki so trajala do 2 leti, se je z zdravilom TESAVEL v odmerku 100 mg na dan samim ali v kombinaciji z metforminom, s sulfonilse nino (z metforminom ali brez) ali z agonistom PPARγ zdravilo ve kot 2. 700 bolnikov.
In these trials, the rate of discontinuation due to adverse experiences considered drug-related was 0.8% with 100 mg per day and 1.5% with other treatments.
Med temi preskušanji je bil delež izklju itev zaradi z zdravilom povezanih neželenih u inkov pri odmerjanju 100 mg na dan 0, 8%, pri drugih oblikah zdravljenja pa 1, 5%.
No adverse reactions considered as drug-related were reported in patients treated with sitagliptin occurring in excess (> 0.2% and difference > 1 patient) of that in patients treated with control.
Pri bolnikih, ki so se zdravili s sitagliptinom, niso poro ali o z zdravilom povezanih neželenih u inkih, ki bi se pojavili pogosteje (> 0, 2% in razlika > 1 bolnik) kot pri bolnikih, ki so se zdravili s kontrolnim zdravilom.
Adverse reactions considered as drug-related reported in patients treated with sitagliptin occurring in excess (> 0.2% and difference > 1 patient) of that in patients treated with placebo are listed below (Table 1) by system organ class and frequency.
Z zdravilom povezani neželeni u inki, o katerih so poro ali pri bolnikih, ki so se zdravili s sitagliptinom, in ki so se pojavili pogosteje (> 0, 2% in razlika > 1 bolnik) kot pri bolnikih, ki so prejemali placebo, so v nadaljevanju (Tabela 1) navedeni po organskih sistemih in pogostnosti.
Frequencies are defined as: very common (≥ 1/ 10); common (≥ 1/ 100, < 1/ 10); uncommon (≥ 1/ 1000, < 1/ 100); rare (≥ 1/ 10000, < 1/ 1000); and very rare (< 1/ 10000).
Pogostnost je definirana kot: zelo pogosti (1/ 10), pogosti (1/ 100, < 1/ 10), ob asni (1/ 1. 000, < 1/ 100), redki (1/ 10. 000, < 1/ 1. 000) in zelo redki (< 1/ 10. 000).
The frequency of adverse reactions identified from placebo-controlled clinical studies
Pogostnost neželenih u inkov iz s placebom nadzorovanih klini nih študij
Adverse Reaction
Neželeni u inek
Frequency of adverse reaction by treatment regimen
Pogostnost neželenih u inkov glede na režim zdravljenja
Metabolism and nutrition disorders
kombinaciji z
hypoglycaemia*
metforminom1
Very common
sulfonilse nino2
Very common Common
agonistom γ PPARγ
Nervous system disorders somnolence
Presnovne in prehranske motnje Hipoglikemija *
Gastrointestinal disorders
Bolezni živ evja
diarrhea nausea flatulence constipation upper abdominal pain
Bolezni prebavil Driska Navzea Flatulenca Obstipacija Bole ina v zgornjem predelu trebuha
Uncommon Common Uncommon
Ob asni Pogosti Ob asni
Investigations blood glucose decreased *
5 Preiskave Zmanjšana koncentracija glukoze v krvi *
Uncommon
Ob asni
In clinical trials of TESAVEL as monotherapy and sitagliptin as part of combination therapy with metformin or pioglitazone, rates of hypoglycaemia reported with sitagliptin were similar to rates in patients taking placebo.
V klini nih preskušanjih zdravila TESAVEL kot samostojnega zdravila in sitagliptina v kombinaciji z metforminom ali pioglitazonom, so pri bolnikih, ki so prejemali sitagliptin, poro ali o podobnem deležu hipoglikemije kot pri bolnikih, ki so prejemali placebo.
1 In this placebo-controlled 24-week study of sitagliptin 100 mg once daily in combination with metformin, the incidence of adverse reactions considered as drug-related in patients treated with sitagliptin/ metformin compared to treatment with placebo/ metformin was 9.3% and 10.1%, respectively.
1 V tej 24- tedenski s placebom nadzorovani študiji s 100 mg odmerkom sitagliptina enkrat na dan v kombinaciji z metforminom je bila pojavnost z zdravilom povezanih neželenih u inkov pri bolnikih, ki so se zdravili s kombinacijo sitagliptin/ metformin 9, 3- odstotna, pri bolnikih, ki so se zdravili s kombinacijo placebo/ metformin pa 10, 1- odstotna.
5 In an additional 1-year study of sitagliptin 100 mg once daily in combination with metformin, the incidence of adverse reactions considered as drug-related in patients treated with sitagliptin/ metformin compared to sulphonylurea/ metformin was 14.5% and 30.3%, respectively.
V dodatni 1- letni študiji s 100 mg odmerkom sitagliptina enkrat na dan v kombinaciji z metforminom je bila pojavnost z zdravilom povezanih neželenih u inkov pri bolnikih, ki so se zdravili s kombinacijo sitagliptin/ metformin 14, 5- odstotna, pri bolnikih, ki so prejemali kombinacijo sulfonilse nina/ metformin pa 30, 3- odstotna.
In pooled studies of up to 1 year in duration comparing sitagliptin/ metformin to a sulphonylurea agent/ metformin, adverse reactions considered as drug-related reported in patients treated with sitagliptin 100 mg occurring in excess (> 0.2% and difference > 1 patient) of that in patients receiving the sulphonylurea agent are as follows: anorexia (Metabolism and nutritional disorders; frequency uncommon) and weight decreased (Investigations; frequency uncommon).
Ti neželeni u inki so: anoreksija (Presnovne in prehranske motnje; pogostnost ob asna) in zmanjšanje telesne mase (Preiskave; pogostnost ob asna).
2 In this 24-week study of sitagliptin 100 mg once daily in combination with glimepiride, the incidence of adverse reactions considered as drug-related in patients treated with sitagliptin/ glimepiride compared to treatment with placebo/ glimepiride was 11.3% and 6.6%, respectively.
2 V tej 24- tedenski študiji s 100 mg odmerkom sitagliptina enkrat na dan v kombinaciji z glimepiridom je bila pojavnost z zdravilom povezanih neželenih u inkov pri bolnikih, ki so se zdravili s kombinacijo sitagliptin/ glimepirid 11, 3- odstotna, pri bolnikih, ki so se zdravili s kombinacijo placebo/ glimepirid pa 6, 6- odstotna.
3 In this 24-week study of sitagliptin 100 mg once daily in combination with glimepiride and metformin, the incidence of adverse reactions considered as drug-related in patients treated with sitagliptin in combination with glimepiride/ metformin compared to treatment with placebo in combination with glimepiride/ metformin was 18.1% and 7.1%, respectively.
3 V tej 24- tedenski študiji s 100 mg odmerkom sitagliptina enkrat na dan v kombinaciji z glimepiridom in metforminom je bila pojavnost z zdravilom povezanih neželenih u inkov pri bolnikih, ki so se zdravili s sitagliptinom v kombinaciji z glimepiridom in metforminom 18, 1 - odstotna, pri bolnikih, ki so se zdravili s placebom v kombinaciji z glimepiridom in metforminom pa 7, 1- odstotna.
4 In this 24-week study of the combination of sitagliptin 100 mg once daily and pioglitazone, the incidence of adverse reactions considered as drug-related in patients treated with sitagliptin/ pioglitazone compared to patients treated with placebo/ pioglitazone was 9.1% and 9.0%, respectively.
4 V tej 24- tedenski študiji s 100 mg odmerkom sitagliptina enkrat na dan v kombinaciji s pioglitazonom je bila pojavnost z zdravilom povezanih neželenih u inkov pri bolnikih, ki so se zdravili s kombinacijo sitagliptin/ pioglitazon 9, 1- odstotna, pri bolnikih, ki so se zdravili s kombinacijo placebo/ pioglitazon pa 9, 0- odstotna.
In addition, in monotherapy studies of up to 24 weeks in duration of sitagliptin 100 mg once daily alone compared to placebo, adverse reactions considered as drug-related reported in patients treated with sitagliptin in excess (> 0.2% and difference > 1 patient) of that in patients receiving placebo are headache, hypoglycaemia, constipation, and dizziness.
Z zdravilom povezani neželeni u inki, o katerih so pri bolnikih, ki so se zdravili s sitagliptinom, poro ali pogosteje (> 0, 2% in razlika > 1 bolnik) kot pri bolnikih, ki so prejemali placebo, so: glavobol, hipoglikemija, zaprtost in omotica.
In addition to the drug-related adverse experiences described above, adverse experiences reported regardless of causal relationship to medication and occurring in at least 5% and more commonly in patients treated with TESAVEL included upper respiratory tract infection and nasopharyngitis.
Neželeni u inki, katerih pojavnost je bila vsaj 5 - odstotna in so se pri bolnikih, ki so se zdravili z zdravilom TESAVEL pojavili pogosteje, so okužba zgornjih dihalnih poti in nazofaringitis.
Additional adverse experiences reported regardless of causal relationship to medication that occurred more frequently in patients treated with TESAVEL (not reaching the 5% level, but occurring with an incidence of > 0.5% higher with TESAVEL than that in the control group) included osteoarthritis and pain in extremity.
Dodatni neželeni u inki o katerih so poro ali ne glede na vzro no povezavo z zdravilom in so bili pri bolnikih, ki so se zdravili z zdravilom TESAVEL pogostejši (niso dosegli 5- odstotne pojavnosti, vendar pa je bila njihova pojavnost v skupini, ki je prejemala zdravilo TESAVEL, za > 0, 5% ve ja od pojavnosti v kontrolni skupini), vklju ujejo osteoartritis in bole ino v okon inah.
In a 24-week study of initial combination therapy with sitagliptin and metformin administered twice daily (sitagliptin/ metformin 50 mg/ 500 mg or 50 mg/ 1000 mg), the overall incidence of adverse reactions considered as drug-related in patients treated with the combination of sitagliptin and metformin compared to patients treated with placebo was 14.0% and 9.7%, respectively.
6 V 24- tedenski študiji za etnega kombiniranega zdravljenja s sitagliptinom in metforminom dvakrat na dan (sitagliptin/ metformin 50 mg/ 500 mg ali 50 mg/ 1. 000 mg) je bila celotna pojavnost z zdravilom povezanih neželenih u inkov pri bolnikih, ki so prejemali kombinacijo sitagliptina in metformina, 14, 0- odstotna, pri bolnikih, ki so prejemali placebo pa 9, 7- odstotna.
The overall incidence of adverse reactions considered as drug-related in patients treated with the combination of sitagliptin and metformin was comparable to metformin alone (14.0% each) and greater than sitagliptin alone (6.7%), with the differences relative to sitagliptin alone primarily due to gastrointestinal adverse reactions.
Pri bolnikih, ki so prejemali sitagliptin in metforminom, je bila celotna pojavnost z zdravilom povezanih neželenih u inkov primerljiva s pojavnostjo pri uporabi metformina samega (14, 0% v obeh skupinah) in ve ja kot pri uporabi sitagliptina samega (6, 7%), pri emer so bile razlike v primerjavi z uporabo sitagliptina samega predvsem posledica neželenih u inkov v prebavilih.
Across clinical studies, a small increase in white blood cell count (approximately 200 cells/ microl difference in WBC vs. placebo; mean baseline WBC approximately 6600 cells/ microl) was observed due to an increase in neutrophils.
Med klini nimi študijami so opazili manjše pove anje števila levkocitov (razlika v številu levkocitov v primerjavi s placebom približno 200 celic/ mikroliter; srednje število levkocitov v izhodiš u približno 6. 600 celic/ mikroliter), kar je bila posledica pove anja števila nevtrofilcev.
This observation was seen in most but not all studies.
To razliko so opazili pri ve ini vendar pa ne v vseh študijah.
This change in laboratory parameters is not considered to be clinically relevant.
Ta sprememba laboratorijskih parametrov ne velja za klini no pomembno.
No clinically meaningful changes in vital signs or in ECG (including in QTc interval) were observed with TESAVEL treatment.
Med zdravljenjem z zdravilom TESAVEL niso opazili klini no pomembnih sprememb vitalnih znakov ali EKG- ja (vklju no z intervalom QTc).
During post-marketing experience the following additional side effects have been reported (frequency not known): hypersensitivity reactions including anaphylaxis, angioedema, rash, urticaria, and exfoliative skin conditions including Stevens-Johnson syndrome (see section 4.4).
Postmarketinške izkušnje Dodatni neželeni u inki, o katerih so poro ali v asu trženja (pogostost ni znana): preob utljivostne reakcije, vklju no z anafilakti nimi reakcijami, angioedemom, izpuš ajem, urtikarijo in luš enjem kože, vklju no s Stevens- Johnson- ovim sindromom (glejte poglavje 4. 4).
During controlled clinical trials in healthy subjects, single doses of up to 800 mg sitagliptin were generally well tolerated.
Med nadzorovanimi klini nimi preskušanji so zdrave osebe enkratne odmerke do 800 mg sitagliptina na splošno dobro prenašale.
Minimal increases in QTc, not considered to be clinically relevant, were observed in one study at a dose of 800 mg sitagliptin.
V eni študiji so pri odmerku 800 mg sitagliptina opazili minimalno podaljšanje intervala QTc, ki pa ni veljalo za klini no pomembno.
There is no experience with doses above 800 mg in humans.
Pri loveku ni izkušenj z odmerki, ve jimi od 800 mg.
In the event of an overdose, it is reasonable to employ the usual supportive measures, e. g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring (including obtaining an electrocardiogram), and institute supportive therapy if required.
V primeru prevelikega odmerjanja so upravi eni obi ajni podporni ukrepi, npr. odstranitev neabsorbiranega zdravila iz prebavil, uvedba klini nega nadzora (vklju no s spremljanjem elektrokardiograma) in po potrebi uvedba podpornega zdravljenja.
In clinical studies, approximately 13.5% of the dose was removed over a 3- to 4-hour hemodialysis session.
Odstranitev sitagliptina z dializo je zmerna.
Prolonged hemodialysis may be considered if clinically appropriate.
Med klini nimi študijami se je med 3 - do 4- urno hemodializo odstranilo približno 13, 5% odmerka. e je klini no upravi eno, se lahko razmisli o podaljšani hemodializi.
It is not known if sitagliptin is dialyzable by peritoneal dialysis.
Ni znano, e se sitagliptin odstrani s peritonealno dializo.
TESAVEL is a member of a class of oral anti-hyperglycaemic agents called dipeptidyl peptidase 4 (DPP-4) inhibitors.
Zdravilo TESAVEL spada v skupino peroralnih antidiabetikov, imenovanih zaviralci dipeptidil peptidaze 4 (DPP- 4).
The improvement in glycaemic control observed with this agent may be mediated by enhancing the levels of active incretin hormones.
Z zdravilom dosežena boljša urejenosti glikemije je lahko posledica pove anja koli ine aktivnih inkretinov.
Incretin hormones, including glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), are released by the intestine throughout the day, and levels are increased in response to a meal.
Inkretini, med katere spadata glukagonu podobni peptid 1 (GLP- 1; “ glucagon- like peptide- 1 ”) in od glukoze odvisni insulinotropni polipeptid (GIP; “ glucose- dependent insulinotropic polypeptide ”), se izlo ajo iz revesa ves dan, njihove koli ine pa se po jedi pove ajo.
When blood glucose concentrations are normal or elevated, GLP-1 and GIP increase insulin synthesis and release from pancreatic beta cells by intracellular signaling pathways involving cyclic AMP.
Inkretini so del endokrinega sistema, ki sodeluje pri fiziološkem uravnavanju homeostaze glukoze. e so koncentracije glukoze v krvi normalne ali zvišane, GLP- 1 in GIP preko znotrajceli nih signalnih mehanizmov, ki vklju ujejo cikli ni AMP, pove ata sintezo in sproš anje insulina iz beta celic trebušne slinavke.
Treatment with GLP-1 or with DPP-4 inhibitors in animal models of type 2 diabetes has been demonstrated to improve beta cell responsiveness to glucose and stimulate insulin biosynthesis and release.
Na živalskih modelih sladkorne bolezni tipa 2 je bilo dokazano, da zdravljenje z GLP- 1 ali zaviralci DPP- 4 izboljša odzivnost beta celic za glukozo in stimulira biosintezo ter izlo anje insulina.
With higher insulin levels, tissue glucose uptake is enhanced.
Višje vrednosti insulina pove ajo vstop glukoze v tkiva.
In addition, GLP-1 lowers glucagon secretion from pancreatic alpha cells.
GLP- 1 tudi zmanjšuje
Decreased glucagon concentrations, along with higher insulin levels, lead to reduced hepatic glucose production, resulting in a decrease in blood glucose levels.
Zmanjšane koncentracije glukagona skupaj z ve jimi vrednosti insulina zmanjšajo nastajanje glukoze v jetrih, kar se odraža z nižjimi vrednostmi glukoze v krvi.
The effects of GLP-1 and GIP are glucose-dependent such that when blood glucose concentrations are low, stimulation of insulin release and suppression of glucagon secretion by GLP-1 are not observed.
U inki GLP- 1 in GIP so odvisni od vrednosti glukoze, tako da pri nizkih vrednostih glukoze v krvi stimulacije sproš anja insulina in zaviranja izlo anja glukagona z GLP- 1 niso opazili.
For both GLP-1 and GIP, stimulation of insulin release is enhanced as glucose rises above normal concentrations.
Oba GLP- 1 in GIP, mo neje stimulirata sproš anje insulina, ko se koncentracije glukoze zvišajo nad normalne vrednosti.
The activity of GLP-1 and GIP is limited by the DPP-4 enzyme, which rapidly hydrolyzes the incretin hormones to produce inactive products.
Aktivnost GLP- 1 in GIP je omejena z encimom DPP- 4, ki inkretine hitro hidrolizira do neaktivnih hidrolizatov.
Sitagliptin prevents the hydrolysis of incretin hormones by DPP-4, thereby increasing plasma concentrations of the active forms of GLP-1 and GIP.
Sitagliptin prepre uje hidrolizo inkretinov z DPP- 4 in tako pove uje plazemske koncentracije aktivnih oblik GLP- 1 in GIP.
By enhancing active incretin levels, sitagliptin increases insulin release and decreases glucagon levels in a glucose- dependent manner.
S pove anjem vrednosti aktivnih inkretinov sitagliptin pove uje izlo anje insulina in zmanjšuje vrednosti glukagona na od glukoze odvisen na in.
In patients with type 2 diabetes with hyperglycaemia, these changes in insulin and glucagon levels lead to lower hemoglobin A1c (HbA1c) and lower fasting and postprandial glucose concentrations.
Pri bolnikih s sladkorno boleznijo tipa 2 s hiperglikemijo te spremembe vrednosti insulina in glukagona vodijo do znižanja vrednosti hemoglobina A1c (HbA1c) in zmanjšajo koncentracije glukoze na teš e in po obroku.
The glucose-dependent mechanism of sitagliptin is distinct from the mechanism of sulphonylureas, which increase insulin secretion even when glucose levels are low and can lead to hypoglycaemia in patients with type 2 diabetes and in normal subjects.
Mehanizem delovanja sitagliptina, ki je odvisen od vrednosti glukoze, se razlikuje od mehanizma delovanja sulfonilse nin, ki pove ajo izlo anje insulina tudi pri nizkih koncentracijah glukoze in lahko tako pri bolnikih s sladkorno boleznijo tipa 2 kot pri zdravih osebah povzro ijo hipoglikemijo.
Sitagliptin is a potent and highly selective inhibitor of the enzyme DPP-4 and does not inhibit the closely-related enzymes DPP-8 or DPP-9 at therapeutic concentrations.
Sitagliptin je mo an in visoko selektiven zaviralec encima DPP- 4 in pri terapevtskih koncentracijah ne zavira tesno povezanih encimov DPP- 8 ali DPP- 9.
7 Overall, sitagliptin improved glycaemic control when given as monotherapy, when used in combination with metformin (initial or add-on therapy), in combination with a sulphonylurea (with or without metformin), and in combination with a thiazolidinedione, as measured by clinically relevant reductions in HbA1c from baseline at study endpoint (see Table 2).
Pri samostojnem zdravljenju s sitagliptinom in pri zdravljenju v kombinaciji z metforminom (za etno zdravljenje ali dodatna uvedba sitagliptina), v kombinaciji s sulfonilse nino (z metforminom ali brez) ter v kombinaciji s tiazolidindionom, se je celotna urejenost glikemije izboljšala, kar je bilo dokazano s klini no pomembnim zmanjšanjem vrednosti HbA1c od izhodiš a pri opazovanem študijskem dogodku (glejte Tabela 2).
Two studies were conducted to evaluate the efficacy and safety of TESAVEL monotherapy.
Izvedeni sta bili dve študiji, ki sta ovrednotili u inkovitost in varnost zdravila TESAVEL kot samostojnega zdravila.
Treatment with sitagliptin at 100 mg once daily as monotherapy provided significant improvements in HbA1c, fasting plasma glucose (FPG), and 2-hour post-prandial glucose (2-hour PPG), compared to placebo in two studies, one of 18- and one of 24-weeks duration.
V dveh študijah, od katerih je ena trajala 18 druga pa 24 tednov, so se v primerjavi s placebom pri samostojnem zdravljenju s sitagliptinom v odmerku 100 mg enkrat na dan pomembno izboljšale vrednosti HbA1c, vrednosti glukoze v plazmi na teš e in vrednosti glukoze v plazmi 2 uri po obroku.
Improvement of surrogate markers of beta cell function, including HOMA-β (Homeostasis Model Assessment-β), proinsulin to insulin ratio, and measures of beta cell responsiveness from the frequently-sampled meal tolerance test were observed.
Opazili so izboljšanje surogatnih markerjev funkcije beta celic, vklju no s HOMA - (Homeostasis Model Assessment -), razmerjem proinsulin/ insulin in meritvami beta celi ne funkcije po pogosto izvedenem toleran nem testu s hrano.
The observed incidence of hypoglycaemia in patients treated with TESAVEL was similar to placebo.
Pri bolnikih, ki so se zdravili z zdravilom TESAVEL, je bila opažena podobna pojavnost hipoglikemije kot pri bolnikih, ki so prejemali placebo.