natgillin/translations-raw huggingface dataset:
Alogliptin is primarily excreted unchanged in the urine and metabolism by the cytochrome (CYP) P450 enzyme system is negligible (see section 5.2). 
Alogliptin se prvenstveno izlučuje nepromijenjen u mokraći, a metabolizam putem enzimatskog sustava citokroma (CYP) P450 mu je zanemariv (vidjeti dio 5.2.).
In the alogliptin group, 12.7% (344 subjects) experienced an event within the secondary MACE composite endpoint, compared with 13.4% (359 subjects) in the placebo group [Hazard Ratio = 0.95; 1-sided 99% Confidence Interval: 0-1.14]. 
U skupini na alogliptinu, 12,7% (344 ispitanika) imalo je događaj unutar sekundarnog MACE kompozitnog ishoda, u usporedbi s 13,4% (359 ispitanika) u skupini na placebu [omjer hazarda = 0,95; 1-stran 99% Interval pouzdanosti:
Since insulin and pioglitazone are both associated with fluid retention, concomitant administration may increase the risk of oedema. 
Budući da su i inzulin i pioglitazon povezani sa zadržavanjem tekućine, njihova istodobna primjena može povećati rizik od pojave edema.
Use with other antihyperglycaemic medicinal products and hypoglycaemia 
Primjena s drugim antihiperglikemijskim lijekovima i hipoglikemija
Hypersensitivity reactions, including anaphylactic reactions, angioedema and exfoliative skin conditions including Stevens-Johnson syndrome and erythema multiforme have been observed for DPP-4 inhibitors and have been spontaneously reported for alogliptin in the post-marketing setting. 
Reakcije preosjetljivosti, uključujući i anafilaktičke reakcije, angioedem i eksfolijativna stanja kože uključujući Stevens-Johnsonov sindrom i erythema multiforme opažena su za DPP-4 inhibitore i spontano su prijavljene za alogliptin nakon stavljanja lijeka u promet.
Results from alogliptin studies with metformin, pioglitazone (thiazolidinedione), voglibose (alphaglucosidase inhibitor) and glyburide (sulphonylurea) have shown no clinically relevant pharmacokinetic interactions. 
Rezultati ispitivanja alogliptina s metforminom, pioglitazonom (tiazolidindion), voglibozom (inhibitor alfa-glukozidaze) i gliburidom (sulfonilureja) nisu pokazali klinički značajne farmakokinetičke interakcije.
Risk factors for bladder cancer should be assessed before initiating Incresync treatment (risks include age, smoking history, exposure to some occupational or chemotherapy medicinal products e.g. cyclophosphamide or prior radiation treatment in the pelvic region). 
Prije početka liječenja Incresyncom treba procijeniti faktore rizika za karcinom mokraćnog mjehura (rizici uključuju dob, pušenje u anamnezi, profesionalnu izloženost nekim tvarima ili kemoterapijskim lijekovima, npr. ciklofosfamidu ili prethodnu radioterapiju u području zdjelice).
The maximum recommended daily dose is one 25 mg/45 mg tablet. 
Najveća preporučena dnevna doza je jedna tableta od 25 mg/45 mg.
In addition, a prospective randomised cardiovascular outcomes safety study was conducted with 5,380 patients with high underlying cardiovascular risk to examine the effect of alogliptin compared with placebo (when added to standard of care) on major adverse cardiovascular events (MACE) including time to the first occurrence of any event in the composite of cardiovascular death, nonfatal myocardial infarction and nonfatal stroke in patients with a recent (15 to 90 days) acute coronary event. 
Dodatno, prospektivno randomizirano ispitivanje sigurnosti s obzirom na kardiovaskularne ishode provedeno je na 5380 bolesnika s visokim podležećim kardiovaskularnim rizikom kako bi se ispitao učinak alogliptina u usporedbi s placebom (kao dodatak standardnoj terapiji) na velike kardiovaskularne štetne događaje (engl. major adverse cardiovascular events, MACE) uključujući i vrijeme do prve pojave bilo kojeg od događaja kardiovaskularne smrti, infarkta miokarda bez smrtnog ishoda i moždanog udara bez smrtnog ishoda u bolesnika s nedavnim (15 do 90 dana) akutnim koronarnim događajem.
The incidence of hypoglycaemia was greater when alogliptin was used as triple therapy with pioglitazone and metformin (compared to active-control). 
Incidencija hipoglikemije je bila veća kad se alogliptin primjenjivao kao dio trojne terapije s pioglitazonom i metforminom (u usporedbi s aktivnom kontrolom).
In case of hypoglycaemia, a lower dose of the thiazolidinedione or metformin may be considered. 
U slučaju hipoglikemije treba razmotriti nižu dozu tiazolidindiona ili metformina.
In light of age-related risks (especially bladder cancer, fractures and heart failure associated with the pioglitazone component), the balance of benefits and risks should be considered carefully both before and during Incresync treatment in the elderly. 
U svjetlu rizika povezanih sa životnom dobi (osobito karcinom mokraćnog mjehura, prijelomi i zatajenje srca povezani sa sadržanim pioglitazonom), potrebno je pažljivo razmotriti omjer koristi i rizika prije i tijekom liječenja starijih bolesnika Incresyncom.
Hypoglycaemia may occur in combination with sulphonylureas or insulin. 
Hipoglikemija može nastati u kombinaciji sa sulfonilurejama ili inzulinom.
Incresync contains lactose 
Incresync sadrži laktozu
No effects on the toxicokinetics of either compound were observed. 
Nisu opaženi učinci na toksikokinetiku bilo koje od djelatnih tvari.
In clinical studies with pioglitazone, there was evidence of dose-related weight gain, which may be due to fat accumulation and, in some cases, associated with fluid retention. 
U kliničkim ispitivanjima pioglitazona bilo je dokaza povećanja tjelesne težine povezanog s dozom, što može biti zbog nakupljanja masnog tkiva i u nekim slučajevima, povezano sa zadržavanjem tekućine.
Hepatic impairment Incresync must not be used in patients with hepatic impairment (see sections 4.3, 4.4 and 5.2). 
Incresync se ne smije primjenjivati u bolesnika s oštećenjem jetre (vidjeti dijelove 4.3, 4.4 i 5.2).
However, dosing of alogliptin should be conservative in patients with advanced age due to the potential for decreased renal function in this population. 
Međutim, u bolesnika uznapredovale dobi doziranje alogliptina treba biti konzervativno zbog moguće smanjene funkcije bubrega u toj populaciji.
In an outcome study of patients with pre-existing major macrovascular disease, the incidence of serious heart failure was 1.6% higher with pioglitazone than with placebo when added to therapy that included insulin. 
U ispitivanju ishoda u bolesnika s već postojećom velikom makrovaskularnom bolešću, incidencija ozbiljnog zatajenja srca bila je 1,6% viša uz pioglitazon nego uz placebo kad se dodaju terapiji koja uključuje inzulin.
- A severe allergic reaction: skin lesions or spots on your skin that can progress to a sore surrounded by pale or red rings, blistering and/or peeling of the skin possibly with symptoms such as itching, fever, overall ill feeling, achy joints, vision problems, burning, painful or itchy eyes and mouth sores (Stevens-Johnson syndrome and Erythema multiforme). 
• Teška alergijska reakcija: oštećenja ili mrlje na koži, koje mogu napredovati do rana okruženih blijedim ili crvenim prstenovima, stvaranje mjehura i/ili ljuštenje kože, moguće sa simptomima poput svrbeža, vrućice, općeg lošeg osjećanja, bolnih zglobova, problema s vidom, pečenja, boli ili svrbeža očiju, te rana po sluznici usta (Stevens-Johnsonov sindrom i Erythema multiforme).
For patients intolerant to metformin or for whom metformin is contraindicated, inadequately controlled on pioglitazone alone, the recommended dose of Incresync is one tablet of 25 mg/30 mg or 25 mg/45 mg once daily, depending on the dose of pioglitazone already being taken. 
Za bolesnike koji ne podnose metformin ili kojima je metformin kontraindiciran, a neodgovarajuće su kontrolirani samim pioglitazonom, preporučena doza Incresynca je jedna tableta od 25 mg/30 mg ili 25 mg/45 mg jedanput na dan, ovisno o dozi pioglitazona koju bolesnik već uzima.
GLP-1 and GIP increases insulin biosynthesis and secretion from pancreatic beta cells, while GLP-1 also inhibits glucagon secretion and hepatic glucose production. 
GLP-1 i GIP povećavaju biosintezu inzulina i lučenje iz beta-stanica gušterače, dok GLP-1 također inhibira lučenje glukagona i stvaranje glukoze u jetri.
The no-observed-adverse-effect level (NOAEL) in the repeated dose toxicity studies in rats and dogs up to 26- and 39-weeks in duration, respectively, produced exposure margins that were approximately 147- and 227-fold, respectively, the exposure in humans at the recommended daily dose of 25 mg alogliptin. 
Razina bez opaženih nuspojava (RBON) u ispitivanjima toksičnosti ponovljenih doza u štakora i pasa u trajanju od 26 i 39 tjedana pokazala je marginu izloženosti koja je za približno 147, odnosno 227 puta veća od izloženost u ljudi pri preporučenoj dozi od 25 mg alogliptina.
Studies in animals with alogliptin plus pioglitazone as combination treatment have shown reproductive toxicity (slight augmentation of pioglitazone-related foetal growth retardation and foetal visceral variations, see section 5.3). 
Ispitivanja na životinjama alogliptina i pioglitazona kao kombiniranog liječenja pokazala su reproduktivnu toksičnost (blago povećanje s pioglitazonom povezanog zaostajanja u fetalnom rastu i fetalnih visceralnih varijacija, vidjeti dio 5.3).
The safety and efficacy of Incresync in children and adolescents < 18 years old have not been established. 
Sigurnost i djelotvornost lijeka Incresync u djece i adolescenata < 18 godina starosti nisu utvrđene.
In the prospective randomised controlled cardiovascular outcomes study, investigator reported events of hypoglycemia were similar in patients receiving placebo (6.5%) and patients receiving alogliptin (6.7%) in addition to standard of care. 
U prospektivnom randomiziranom kontroliranom ispitivanju kardiovaskularnih ishoda, događaji hipoglikemije koje su prijavili ispitivači bili su slični u bolesnika koji su primali placebo (6,5%) i bolesnika koji su primali alogliptin (6,7%) kao dodatak standardnoj terapiji.
Since there is a potential for an increase in dose-related adverse reactions, a decrease in the dose of pioglitazone may be needed when gemfibrozil is concomitantly administered. 
Budući da postoji mogućnost povećanja nuspojava povezanih s dozom, možda bude potrebno sniziti dozu pioglitazona kod istodobne primjene s gemfibrozilom.
Additional symptoms may include general itching and feeling of heat especially affecting the scalp, mouth, throat, palms of hands and soles of feet (Stevens-Johnson syndrome). 
Simptomi mogu uključivati generalizirani svrbež i osjećaj vrućine koji posebice zahvaća tjeme, usta, grlo, dlanove ruku i tabane nogu (Stevens-Johnsonov sindrom)
For patients with mild renal impairment (creatinine clearance (CrCl) > 50 to ≤ 80 mL/min), no dose adjustment of Incresync is necessary (see section 5.2). 
Za bolesnike s blagim oštećenjem bubrega (klirens kreatinina >50 do ≤ 80 ml/min) nije potrebna prilagodba doze Incresynca (vidjeti dio 5.2).
Table 4. 
Tablica 7.
In one-year clinical studies, pioglitazone consistently gave a statistically significant reduction in the albumin/creatinine ratio compared to baseline. 
U kliničkim ispitivanjima u trajanju od jedne godine, pioglitazon je dosljedno pokazivao statistički značajno sniženje omjera albumin/kreatinin u usporedbi s početnim omjerom.
There is no induction of the main inducible P450 isoenzymes 1A, 2C8/9 and 3A4 in man. 
Nema indukcije glavnih induktibilnih izoenzima P450 1A, 2C8/9 i 3A4 u čovjeka.
No data are available with regard to overdose of Incresync. 
Nema dostupnih podataka o predoziranju Incresyncom.
In active comparator-controlled studies, mean weight increase with pioglitazone given as monotherapy was 2-3 kg over one year. 
U ispitivanjima kontroliranima aktivnim usporednim lijekom, srednja vrijednost povećanja težine tijekom monoterapije pioglitazonom bila je 2-3 kg tijekom jedne godine.
The risk of fractures should be considered in the long-term care of patients treated with Incresync (see section 4.8). 
Rizik od prijeloma treba uzeti u obzir kod dugotrajnog liječenja bolesnika lijekom Incresync (vidjeti dio 4.8).
Incresync should not be used during pregnancy or breast-feeding. 
Incresync se ne smije koristiti tijekom trudnoće ili dojenja.
Immune system disorders hypersensitivity not known hypersensitivity and allergic reactions not known 
Poremećaji imunološkog sustava Preosjetljivost i alergijske reakcije
No clinically relevant accumulation after multiple dosing was observed in either healthy subjects or in patients with type 2 diabetes mellitus. 
Nakon višestrukog doziranja nije opažena klinički značajna akumulacija u zdravih ispitanika ni u bolesnika sa šećernom bolešću tipa 2.
Incresync combines two antihyperglycaemic medicinal products with complementary and distinct mechanisms of action to improve glycaemic control in patients with type 2 diabetes mellitus: alogliptin, a dipeptidyl-peptidase-4 (DPP-4) inhibitor, and pioglitazone, a member of the thiazolidinedione class. 
Incresync sadrži dva antihiperglikemijska lijeka koji komplementarnim i različitim mehanizmom djelovanja poboljšavaju kontrolu glikemije u bolesnika sa šećernom bolešću tipa 2: alogliptin, inhibitor dipeptidil-peptidaze-4 (DPP4) i pioglitazon, predstavnik klase tiazolidindiona.
The highest doses of alogliptin administered in clinical studies were single doses of 800 mg to healthy subjects and doses of 400 mg once daily for 14 days to patients with type 2 diabetes mellitus (equivalent to 32 times and 16 times the recommended daily dose of 25 mg alogliptin, respectively). 
Najviše doze alogliptina primijenjene u kliničkim ispitivanjima bile su jednokratne doze od 800 mg zdravim ispitanicima i doze od 400 mg jedanput na dan tijekom 14 dana u bolesnika sa šećernom bolešću tipa 2 (što je 32 puta, odnosno 16 puta više od preporučene dnevne doze od 25 mg alogliptina).
The oedema rates for comparator groups (sulphonylurea, metformin) were 2-5%. 
Stope edema u skupinama koje su primale usporedni lijek (sulfonilureju, metformin) bile su 2-5%.
Cardiac failure or history of cardiac failure (NYHA stages I to IV; see section 4.4) Hepatic impairment (see section 4.4) 
• Zatajenje srca ili zatajenje srca u anamnezi (NYHA stadij I do IV; vidjeti dio 4.4)
Symptoms include excessive thirst, frequent urination, loss of appetite, nausea or vomiting and rapid weight loss. 
Simptomi uključuju izrazitu žeđ, često mokrenje, gubitak teka, mučninu ili povraćanje te brzi gubitak težine.
In controlled clinical studies, the incidence of reports of heart failure with pioglitazone treatment was the same as in placebo, metformin and sulphonylurea treatment groups, but was increased when used in combination therapy with insulin. 
U kontroliranim kliničkim ispitivanjima incidencija zatajenja srca uz liječenje pioglitazonom bila je ista kao i u skupinama liječenim placebom, metforminom i sulfonilurejom, ali povećala se kad je korišten u kombiniranoj terapiji s inzulinom.
Similar changes in body fat distribution on pioglitazone have been accompanied by an improvement in insulin sensitivity. 
Slične promjene u distribuciji masnog tkiva u tijelu uz pioglitazon praćene su poboljšanom inzulinskom osjetljivošću.
A single dose of 50 mg alogliptin was administered to 4 groups of patients with varying degrees of renal impairment (CrCl using the Cockcroft-Gault formula): mild (CrCl = > 50 to ≤ 80 mL/min), moderate (CrCl = ≥ 30 to ≤ 50 mL/min), severe (CrCl = < 30 mL/min) and end-stage renal disease on haemodialysis. 
Jednokratna doza od 50 mg alogliptina primijenjena je u 4 skupine bolesnika s različitim stupnjevima oštećenja bubrega (klirens kreatinina (CrCl) prema Cockcroft-Gault formuli): blago (CrCl = > 50 do ≤ 80 ml/min), umjereno (CrCl = ≥ 30 do ≤ 50 ml/min), teško (CrCl = < 30 ml/min) i završni stadij bolesti bubrega na hemodijalizi.
Symptoms of a serious allergic reaction may include; rash, raised red patches on your skin (hives), swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing. 
Simptomi ozbiljne alergijske reakcije mogu uključivati: osip, izdignute crvene mrlje na koži (koprivnjača), oticanje lica, usnica, jezika i grla što može uzrokovati teškoće pri disanju ili gutanju.
Following oral administration, pioglitazone is rapidly absorbed and peak serum concentrations of unchanged pioglitazone are usually achieved 2 hours after administration. 
Nakon peroralne primjene, pioglitazon se brzo apsorbira, a vršne koncentracije neizmijenjenog pioglitazona u plazmi obično se postižu 2 sata nakon primjene.
How to take Incresync 
Kako uzimati Incresync
Investigations weight increased common alanine aminotransferase increased not known 
Povišena alanin aminotransferaza
Alogliptin therefore improves glycaemic control via a glucose-dependent mechanism, whereby insulin release is enhanced and glucagon levels are suppressed when glucose levels are high. 
Alogliptin stoga poboljšava kontrolu glikemije putem mehanizma ovisnog o glukozi, pri čemu se pri visokim razinama glukoze pojačava lučenje inzulina i suprimiraju razine glukagona.
Two minor metabolites were detected following administration of an oral dose of [14C] alogliptin, N-demethylated alogliptin, M-I (< 1% of the parent compound), and N-acetylated alogliptin, M-II (< 6% of the parent compound). 
C] alogliptina nađena su dva minorna metabolita, N-demetilirani alogliptin, M-I (<1% izvornog spoja) i N-acetilirani alogliptin, M-II (<6% izvornog spoja).
Therefore, haemodialysis is of little clinical benefit in overdose. 
Stoga hemodijaliza kod predoziranja ima mali klinički učinak.
- if you are taking an anti-diabetic medicine known as sulphonylurea (e.g. glipizide, tolbutamide, glibenclamide) or insulin. 
• ako uzimate drugi antidijabetički lijek poznat kao „sulfonilureja“ (npr. glipizid, tolbutamid, glibenklamid) ili inzulin
Due to the increased risk of hypoglycaemia in combination with metformin, a lower dose of metformin or the pioglitazone component may be considered to reduce the risk of hypoglycaemia when this combination is used (see section 4.2). 
Zbog povećanog rizika od hipoglikemije u kombinaciji s metforminom, preporučuje se niža doza metformina ili pioglitazona kada se u liječenju primjenjuje ova kombinacija (vidjeti dio 4.2).
• as an adjunct to diet and exercise to improve glycaemic control in adult patients (particularly overweight patients) inadequately controlled on pioglitazone alone, and for whom metformin is inappropriate due to contraindications or intolerance. 
• kao dodatak dijeti i tjelovježbi za poboljšanje kontrole glikemije u odraslih bolesnika (posebice onih s prekomjernom tjelesnom težinom) u kojih nije postignuta odgovarajuća kontrola samo pioglitazonom, a u kojih metformin nije prikladan zbog kontraindikacija ili nepodnošljivosti.
A cardiovascular outcome study of pioglitazone has been performed in patients under 75 years with type 2 diabetes mellitus and pre-existing major macrovascular disease. 
Ispitivanje kardiovaskularnog ishoda kod primjene pioglitazona provedeno je u bolesnika mlađih od 75 godina sa šećernom bolešću tipa 2 i već postojećom teškom makrovaskularnom bolešću.
• The Prescriber Guide 
• Vodič za propisivanje lijeka
You should also discuss with your doctor if you experience the following side effects: 
Savjetujte se s liječnikom ako primijetite sljedeće nuspojave:
Cases of bladder cancer were reported more frequently in a meta-analysis of controlled clinical studies with pioglitazone (19 cases from 12,506 patients, 0.15%) than in control groups (7 cases from 10,212 patients, 0.07%) HR=2.64 (95% CI 1.11-6.31, P=0.029). 
U meta-analizi kontroliranih kliničkih ispitivanja s pioglitazonom češće su prijavljeni slučajevi karcinoma mokraćnog mjehura u skupinama koje su primale pioglitazon (19 slučajeva na 12 506 bolesnika, 0,15%) nego u kontrolnim skupinama (7 slučajeva na 10 212 bolesnika, 0,07%) HR=2,64 (95% CI 1,11-6,31, p=0,029).
The recommended dose is one tablet of 25 mg/30 mg or 25 mg/45 mg once daily, depending on the dose of pioglitazone already being taken. 
Preporučena doza je jedna tableta od 25 mg/30 mg ili 25 mg/45 mg jedanput na dan, ovisno o dozi pioglitazona koju bolesnik već uzima.
The following data are findings from studies performed with alogliptin or pioglitazone individually. 
Sljedeći podaci su nalazi iz ispitivanja provedenih zasebno s alogliptinom ili pioglitazonom.
In light of potential risks with prolonged pioglitazone therapy, prescribers should confirm at subsequent routine reviews that the benefit of Incresync is maintained (see section 4.4). 
S obzirom na moguće rizike produljene terapije pioglitazonom, liječnici koji propisuju lijek trebaju i dalje rutinski procjenjivati da je korist liječenja Incresyncom održana (vidjeti dio 4.4).
Common: - Symptoms of low blood sugar (hypoglycaemia) may occur when Incresync is taken in combination with insulin or sulphonylureas (e.g. glipizide, tolbutamide, glibenclamide). 
• Simptomi niskog šećera u krvi (hipoglikemija) mogu se javiti ako se Incresync uzima u kombinaciji s inzulinom ili sulfonilurejama (npr. glipizid, tolbutamid, glibenklamid).
Minimal quantities of alogliptin are removed by haemodialysis (approximately 7% of the substance was removed during a 3-hour haemodialysis session). 
Hemodijalizom se mogu ukloniti minimalne količine alogliptina (tijekom 3-satne hemodijalize uklonjeno je približno 7% lijeka).
Alogliptin may, therefore, be administered with or without food. 
Alogliptin se, stoga, može primjenjivati s hranom ili bez nje.
The formation and presence of urinary calculi with subsequent irritation and hyperplasia was postulated as the mechanistic basis for the observed tumourigenic response in the male rat. 
Stvaranje i prisutnost kamenaca u mokraćnom traktu s posljedičnom nadraženošću i hiperplazijom postavila se kao temeljni mehanizam opaženog tumorogenog odgovora u mužjaka štakora.
In animal fertility studies conducted with pioglitazone there was no effect on copulation, impregnation or fertility index. 
U ispitivanjima utjecaja na plodnost u životinja nije bilo učinka na kopulaciju, oplodnju ili indeks plodnosti.
Administration of Incresync with food resulted in no change in overall exposure to alogliptin or pioglitazone. 
Primjenom lijeka Incresync s hranom nije bilo promjene u ukupnoj izloženosti alogliptinu ili pioglitazonu.
Clinically meaningful reductions in HbA1c compared to placebo were also observed with 25 mg alogliptin regardless of whether patients were receiving concomitant metformin or sulphonylurea therapy. 
Klinički značajna sniženja HbA1c u usporedbi s placebom s 25 mg alogliptina također su opažena bez obzira na to jesu li bolesnici istodobno primali terapiju metforminom ili sulfonilurejom.
Combination treatment with alogliptin and pioglitazone to pregnant rats slightly augmented pioglitazone-related foetal effects of growth retardation and visceral variations, but did not induce embryo-foetal mortality or teratogenicity. 
Kombinirano liječenje alogliptinom i pioglitazonom je u skotnih štakora blago potaklo s pioglitazonom povezane učinke na fetalni rast i fetalne visceralne varijacije, ali nije izazvalo embriofetalnu smrtnost ili teratogenost.
Steady-state pharmacokinetics is similar in patients aged 65 years and over and young subjects (see section 4.2). 
Farmakokinetika u stanju dinamičke ravnoteže u bolesnika u dobi od 65 ili više godina slična je onoj u mladih ispitanika (vidjeti dio 4.2).
Caution should be exercised when alogliptin is used in combination with metformin and a thiazolidinedione as an increased risk of hypoglycaemia has been observed with this triple therapy (see section 4.4). 
Nužan je oprez kada se alogliptin primjenjuje u kombinaciji s metforminom i tiazolidindionom jer je primijećen povećani rizik od hipoglikemije s ovom trojnom terapijom (vidjeti dio 4.4).
• in combination with metformin (i.e. triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in adult patients (particularly overweight patients) inadequately controlled on their maximal tolerated dose of metformin and pioglitazone. 
• u kombinaciji s metforminom (tj. trojna kombinirana terapija), kao dodatak dijeti i tjelovježbi, za poboljšanje kontrole glikemije u bolesnika (posebice onih s prekomjernom tjelesnom težinom) u kojih nije postignuta odgovarajuća kontrola maksimalnom podnošljivom dozom metformina i pioglitazona.