natgillin/translations-raw huggingface dataset:
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 učinki, o katerih so poročali 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), občasni (≥ 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 učinkov iz s placebom nadzorovanih kliničnih študij
Sitagliptin with Sitagliptin with Sitagliptin with 1 2
Sitagliptin v Sitagliptin v Sitagliptin v
Sitagliptin with
Sitagliptin v
Metformin
kombinaciji z
a Sulfonylurea
kombinaciji s kombinaciji z
Metformin and a a PPARγ Agent Sulfonylurea3 (pioglitazone)4
kombinaciji z kombinaciji s kombinaciji z
Metabolism and nutrition disorders
metforminom in sulfonilsečnino3
hypoglycaemia*
agonistom PPARγ
Very common
(pioglitazon) 4
Very common Common
Presnovne in prehranske motnje Hipoglikemija *
Nervous system disorders somnolence
Zelo pogosti Zelo pogosti
Gastrointestinal disorders
Bolezni živčevja
diarrhea nausea flatulence constipation upper abdominal pain
Bolezni prebavil Driska Navzea Flatulenca Obstipacija Bolečina v zgornjem predelu trebuha
Uncommon Common Uncommon
Občasni Pogosti Občasni
General disorders peripheral oedema
Splošne težava
Investigations blood glucose decreased *
Preiskave Zmanjšana koncentracija glukoze v krvi
In clinical trials of Januvia 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.
5 * V kliničnih preskušanjih zdravila Januvia kot samostojnega zdravila in sitagliptina v kombinaciji z metforminom ali pioglitazonom, so pri bolnikih, ki so prejemali sitagliptin, poročali o podobnem deležu hipoglikemije kot pri bolnikih, ki so prejemali placebo.
5 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 učinkov 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.
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 učinkov pri bolnikih, ki so se zdravili s kombinacijo sitagliptin/ metformin 14, 5- odstotna, pri bolnikih, ki so prejemali kombinacijo sulfonilsečnina/ 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 učinki so: anoreksija (Presnovne in prehranske motnje; pogostnost občasna) in zmanjšanje telesne mase (Preiskave; pogostnost občasna).
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 učinkov 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 učinkov 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 učinkov 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 učinki, o katerih so pri bolnikih, ki so se zdravili s sitagliptinom, poročali 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 Januvia included upper respiratory tract infection and nasopharyngitis.
Neželeni učinki, katerih pojavnost je bila vsaj 5 - odstotna in so se pri bolnikih, ki so se zdravili z zdravilom Januvia 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 Januvia (not reaching the 5% level, but occurring with an incidence of > 0.5% higher with Januvia than that in the control group) included osteoarthritis and pain in extremity.
Dodatni neželeni učinki o katerih so poročali ne glede na vzročno povezavo z zdravilom in so bili pri bolnikih, ki so se zdravili z zdravilom Januvia pogostejši (niso dosegli 5- odstotne pojavnosti, vendar pa je bila njihova pojavnost v skupini, ki je prejemala zdravilo Januvia, za > 0, 5% večja od pojavnosti v kontrolni skupini), vključujejo osteoartritis in bolečino v okončinah.
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.
V 24- tedenski študiji začetnega 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 učinkov 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 učinkov primerljiva s pojavnostjo pri uporabi metformina samega (14, 0% v obeh skupinah) in večja kot pri
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 kliničnimi študijami so opazili manjše povečanje števila levkocitov (razlika v številu levkocitov v primerjavi s placebom približno 200 celic/ mikroliter; srednje število levkocitov v izhodišču približno 6. 600 celic/ mikroliter), kar je bila posledica povečanja števila nevtrofilcev.
This observation was seen in most but not all studies.
To razliko so opazili pri večini vendar pa ne v vseh študijah.
6 No clinically meaningful changes in vital signs or in ECG (including in QTc interval) were observed with Januvia treatment.
Med zdravljenjem z zdravilom Januvia niso opazili klinično pomembnih sprememb vitalnih znakov ali EKG- ja (vključno 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 učinki, o katerih so poročali v času trženja (pogostost ni znana): preobčutljivostne reakcije, vključno z anafilaktičnimi reakcijami, angioedemom, izpuščajem, urtikarijo in luščenjem kože, vključno 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 kliničnimi preskušanji so zdrave osebe enkratne odmerke do 800 mg sitagliptina na splošno dobro prenašale.
There is no experience with doses above 800 mg in humans.
Pri človeku ni izkušenj z odmerki, večjimi 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 upravičeni običajni podporni ukrepi, npr. odstranitev neabsorbiranega zdravila iz prebavil, uvedba kliničnega nadzora (vključno s spremljanjem elektrokardiograma) in po potrebi uvedba podpornega zdravljenja.
Sitagliptin is modestly dialyzable.
Odstranitev sitagliptina z dializo je zmerna.
In clinical studies, approximately 13.5% of the dose was removed over a 3- to 4-hour hemodialysis session.
Med kliničnimi študijami se je med 3 - do 4- urno hemodializo odstranilo približno 13, 5% odmerka.
Prolonged hemodialysis may be considered if clinically appropriate.
Če je klinično upravičeno, se lahko razmisli o podaljšani hemodializi.
It is not known if sitagliptin is dialyzable by peritoneal dialysis.
Ni znano, če se sitagliptin odstrani s peritonealno dializo.
DPP-4 Inhibitor, ATC code:
Farmakoterapevtska skupina: zaviralci DPP- 4, oznaka ATC:
A10BH01.
A10BH01
Januvia is a member of a class of oral anti-hyperglycaemic agents called dipeptidyl peptidase 4 (DPP-4) inhibitors.
Zdravilo Januvia 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 povečanja količine 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 izločajo iz črevesa ves dan, njihove količine pa se po jedi povečajo.
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.
Če so koncentracije glukoze v krvi normalne ali zvišane, GLP- 1 in GIP preko znotrajceličnih signalnih mehanizmov, ki vključujejo ciklični AMP, povečata sintezo in sproščanje 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 izločanje insulina.
With higher insulin levels, tissue glucose uptake is enhanced.
Višje vrednosti insulina povečajo vstop glukoze v tkiva.
In addition, GLP-1 lowers glucagon secretion from pancreatic alpha cells.
GLP- 1 tudi zmanjšuje izločanje glukagona iz alfa celic trebušne slinavke.
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 večjimi 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.
Učinki GLP- 1 in GIP so odvisni od vrednosti glukoze, tako da pri nizkih vrednostih glukoze v krvi stimulacije sproščanja insulina in zaviranja izločanja 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, močneje stimulirata sproščanje insulina, ko se koncentracije glukoze zvišajo nad normalne vrednosti.
Further, GLP-1 does not impair the normal glucagon response to hypoglycaemia.
GLP- 1 tudi ne slabi normalnega odziva glukagona na hipoglikemijo.
The activity of GLP-1 and GIP is limited by the DPP-4 enzyme, which rapidly hydrolyzes the incretin hormones to produce inactive products.
Sitagliptin
Sitagliptin prevents the hydrolysis of incretin hormones by DPP-4, thereby increasing plasma concentrations of the active forms of GLP-1 and GIP.
7 preprečuje hidrolizo inkretinov z DPP- 4 in tako povečuje 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 povečanjem vrednosti aktivnih inkretinov sitagliptin povečuje izločanje insulina in zmanjšuje vrednosti glukagona na od glukoze odvisen način.
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 tešče in po obroku.
Sitagliptin is a potent and
Mehanizem delovanja sitagliptina, ki je odvisen od vrednosti glukoze, se razlikuje od mehanizma delovanja sulfonilsečnin, ki povečajo izločanje insulina tudi pri nizkih koncentracijah glukoze in lahko tako pri bolnikih s sladkorno boleznijo tipa 2 kot pri zdravih osebah povzročijo hipoglikemijo.
7 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 močan in visoko selektiven zaviralec encima DPP- 4 in pri terapevtskih koncentracijah ne zavira tesno povezanih encimov DPP- 8 ali DPP- 9.
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 (začetno zdravljenje ali dodatna uvedba sitagliptina), v kombinaciji s sulfonilsečnino (z metforminom ali brez) ter v kombinaciji s tiazolidindionom, se je celotna urejenost glikemije izboljšala, kar je bilo dokazano s klinično pomembnim zmanjšanjem vrednosti HbA1c od izhodišča pri opazovanem študijskem dogodku (glejte Tabela 2).
Two studies were conducted to evaluate the efficacy and safety of Januvia monotherapy.
Izvedeni sta bili dve študiji, ki sta ovrednotili učinkovitost in varnost zdravila Januvia kot samostojnega zdravila.
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, vključno s HOMA- β (Homeostasis Model Assessment- β), razmerjem proinsulin/ insulin in meritvami beta celične funkcije po pogosto izvedenem tolerančnem testu s hrano.
The observed incidence of hypoglycaemia in patients treated with Januvia was similar to placebo.
Pri bolnikih, ki so se zdravili z zdravilom Januvia, je bila opažena podobna pojavnost hipoglikemije kot pri bolnikih, ki so prejemali placebo.
Body weight did not increase from baseline with sitagliptin therapy in either study, compared to a small reduction in patients given placebo.
Pri bolnikih, ki so prejemali placebo, se je telesna masa rahlo zmanjšala.
In a study in patients with type 2 diabetes and chronic renal insufficiency (creatinine clearance < 50 ml/ min), the safety and tolerability of reduced doses of sitagliptin were investigated and generally similar to placebo.
V študiji pri bolnikih s sladkorno boleznijo tipa 2 in kronično ledvično insuficienco (kreatininski očistek < 50 ml/ min) so raziskovali varnost in prenašanje zmanjšanih odmerkov sitagliptina, ki sta bili na splošno podobni kot pri placebu.
In addition, the reductions in HbA1c and FPG with sitagliptin compared to placebo were generally similar to those observed in other monotherapy studies in patients with normal renal function (see section 5.2).
Pri zdravljenju s sitagliptinom je bilo zmanjšanje vrednosti HbA1C in vrednosti glukoze v plazmi na tešče v primerjavi s placebom na splošno podobno zmanjšanju, opaženemu pri drugih študijah z enim samim zdravilom pri bolnikih z normalnim delovanjem ledvic (glejte poglavje 5. 2).
The number of patients with moderate to severe renal insufficiency was too low to confirm safe use of sitagliptin in this type of patients.
Število bolnikov z zmerno do hudo ledvično insuficienco je bilo premajhno, da bi lahko tudi pri njih potrdili varnost uporabe sitagliptina..
Sitagliptin 100 mg once daily provided significant improvements in glycaemic parameters compared with placebo in two 24-week studies of sitagliptin as add-on therapy, one in combination with metformin and one in combination with pioglitazone.
V dveh 24- tedenskih študijah dodatnega zdravljenja s sitagliptinom (v eni v kombinaciji z metforminom, v drugi v kombinaciji s pioglitazonom) so se v primerjavi s placebom pri uporabi sitagliptina v odmerku 100 mg enkrat na dan glikemični parametri pomembno izboljšali.
A 24-week placebo-controlled study was designed to evaluate the efficacy and safety of sitagliptin (100 mg once daily) added to glimepiride alone or glimepiride in combination with metformin.
Zasnovana je bila 24- tedenska s placebom nadzorovana študija, v kateri so vrednotili učinkovitost in varnost sitagliptina (100 mg enkrat na dan), če so ga dodali glimepiridu samemu ali glimepiridu v kombinaciji z metforminom.
The addition of sitagliptin to either glimepiride alone or to glimepiride and metformin provided significant improvements in glycaemic parameters.
V primerjavi s placebom so se pri dodatku sitagliptina glimepiridu samemu ali glimepiridu in metforminu glikemični parametri pomembno izboljšali.
In a 24-week placebo-controlled factorial study of initial therapy, sitagliptin 50 mg twice daily in combination with metformin (500 mg or 1000 mg twice daily) provided significant improvements in glycaemic parameters compared with either monotherapy.
V 24- tedenski s placebom nadzorovani faktorski študiji začetnega zdravljenja je sitagliptin v odmerku 50 mg dvakrat na dan v kombinaciji z metforminom (500 mg ali 1. 000 mg dvakrat na dan) pomembno izboljšal glikemične parametre v primerjavi z zdravljenjem z vsakim zdravilom posebej.
The incidence of hypoglycaemia was similar across treatment groups.
Pri bolnikih, ki so se zdravili samo s sitagliptinom, se telesna masa v primerjavi z izhodiščem ni spremenila.
Table 2.
8 Tabela 2:
HbA1c results in placebo-controlled monotherapy and combination therapy studies*
Vrednosti HbA1c v s placebom nadzorovanih študijah * pri samostojnem in kombiniranem zdravljenju
change in HbA1c (%) at
Srednja sprememba vrednosti
Study
S placebom korigirana srednja
baseline
Študija
baseline HbA1c (%)
vrednost HbA1c v
Week 24†
HbA1c od izhodišča (%) v 24. tednu †
HbA1c (%)
sprememba
at Week 24†
vrednosti HbA1c (%) v 24. tednu †
(95%
Sitagliptin 100 mg enkrat
CI)
izhodišču (%) Študije samostojnega zdravljenja
Sitagliptin 100 mg once daily§
(95% interval zaupanja) - 0, 6 ‡
8.0
na dan§ (N = 193) Sitagliptin 100 mg enkrat
-0.5
8, 0 - 0, 5
-0.6‡
na dan (N = 229) Sitagliptin 100 mg enkrat na dan, dodan k že potekajočemu
(-0.8, -0.4) -0.8‡ (-1.0, -0.6)
8, 0 - 0, 6 Študije kombiniranega zdravljenja 8, 0 - 0, 7
ongoing metformin therapy (N=453) Sitagliptin 100 mg once daily added to
zdravljenju z metforminom (N = 453) Sitagliptin 100 mg enkrat na dan, dodan k že potekajočemu
-0.7
8, 1 - 0, 9
ongoing pioglitazone therapy (N=163) Sitagliptin 100 mg once daily added to
zdravljenju s pioglitazonom (N = 163) Sitagliptin 100 mg enkrat na dan, dodan k že potekajočemu
-0.9
8, 4 - 0, 3
ongoing glimepiride therapy (N=102) Sitagliptin 100 mg once daily added to
zdravljenju z glimepiridom (N = 102) Sitagliptin 100 mg enkrat na dan, dodan k že potekajočemu zdravljenju z glimepiridom in metforminom (N = 115) Začetno zdravljenje (dvakrat na dan): sitagliptin 50 mg + metformin 500 mg (N = 183) Začetno zdravljenje (dvakrat na dan): sitagliptin 50 mg + metformin 1. 000 mg (N = 178)
(-0.8, -0.3)
8, 3 - 0, 6 8, 8 - 1, 4 8, 8 - 1, 9
-0.9‡ (-1.1, -0.7) -1.6‡
(- 0, 8, - 0, 3) - 0, 9 ‡ (- 1, 1, - 0, 7) - 1, 6 ‡ (- 1, 8, - 1, 3) - 2, 1 ‡ (- 2, 3, - 1, 8)
Sitagliptin 50 mg + metformin 500 mg (N=183) Initial therapy (twice daily):
* Vsi zdravljeni bolniki (analiza vključenih bolnikov “ intention- to- treat analysis ”).
Sitagliptin 50 mg + metformin 1000 mg (N=178)
p < 0, 001 v primerjavi s placebom ali placebom + kombiniranim zdravljenjem. ‡