FrancophonIA/ELRC3.0 huggingface dataset:
English: These studies evaluated the effects of alogliptin on glycaemic control and its safety as monotherapy, as initial combination therapy with metformin or a thiazolidinedione, and as add-on therapy to metformin, or a sulphonylurea, or a thiazolidinedione (with or without metformin or a sulphonylurea), or insulin (with or without metformin).
Croatian: U ispitivanjima su ocijenjeni učinci alogliptina na kontrolu glikemije te njegova sigurnost kao monoterapije, kao inicijalne kombinirane terapije s metforminom ili tiazolidindionom, te kao dodatne terapije uz metformin ili sulfonilureju ili tiazolidindion (s ili bez metformina ili sulfonilureje) ili inzulin (s ili bez metformina).
English: LOCF = last observation carried forward * Non inferiority and superiority statistically demonstrated † Least squares means adjusted for prior antihyperglycaemic therapy status and baseline values
Croatian: PPS = bolesnici koji su završili ispitivanje po protokolu (engl. per protocol set) LOCF = zadnje opažanje preneseno nadalje (engl. last observation carried forward) * Dokazana statistička neinferiornost i superiornost † Srednja vrijednost metodom najmanjih kvadrata prilagođena prema prvobitnom antihiperglikemijskom terapijskom statusu i početnim vrijednostima
English: The significant reductions in HbA1c observed with 25 mg alogliptin plus 30 mg pioglitazone and metformin were consistent over the entire 52-week treatment period compared to 45 mg pioglitazone and metformin (p<0.001 at all time points).
Croatian: Značajno smanjenje HbA1c opaženo za 25 mg alogliptina s 30 mg pioglitazona i metforminom u usporedbi s 45 mg pioglitazona s metforminkloridom bio je dosljedno tijekom čitavog 52-tjednog razdoblja liječenja (p<0,001 u svim vremenskim točkama).
English: By Week 104, mean change from baseline in fasting plasma glucose for 25 mg alogliptin and metformin was -3.2 mg/dL compared with 5.4 mg/dL for glipizide and metformin.
Croatian: Do 104. tjedna srednja vrijednost promjene od početne vrijednosti glukoze u plazmi natašte bila je za 25 mg alogliptina i metformin -3,2 mg/dl u usporedbi s 5,4 mg/dl za glipizid s metforminom.
English: No alogliptin-related effects were observed in juvenile rats following repeat-dose administration for 4 and 8 weeks.
Croatian: U mladih štakora nakon uzastopne primjene tijekom 4 i 8 tjedana nisu opaženi učinci povezani s alogliptinom.
English: Although fertility was not affected, a slight, statistical increase in the number of abnormal sperm was observed in males at an exposure far above the human exposure at the recommended dose.
Croatian: Iako nije bilo utjecaja na plodnost, u mužjaka je pri izloženosti koja je daleko iznad izloženosti kod ljudi pri preporučenoj dozi opaženo je blago, statističko povećanje broja abnormalnih spermija.
English: Symptoms may include: trembling, sweating, anxiety, blurred vision, tingling lips, paleness,
Croatian: Simptomi mogu uključivati: drhtavicu, znojenje, tjeskobu, zamućen vid, trnce u usnicama, bljedilo, promjena raspoloženja i osjećaj smetenosti.
English: Clinically meaningful reductions in HbA1c compared to placebo were also observed with 25 mg alogliptin regardless of whether patients were receiving concomitant metformin therapy.
Croatian: Klinički značajno smanjenje HbA1c u usporedbi s placebom je za 25 mg alogliptina opaženo bez obzira na to jesu li bolesnici usporedno uzimali terapiju metforminom.
English: INFORMATION IN BRAILLE Vipidia 25 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Vipidia 25 mg
English: For the different dose regimens, Vipidia is available in strengths of 25 mg, 12.5 mg and 6.25 mg film-coated tablets.
Croatian: Vipidia je dostupna kao filmom obložene tablete u jačinama od 25 mg, 12,5 mg ili 6,25 mg.
English: Alogliptin has not been studied in patients undergoing peritoneal dialysis (see sections 4.4 and 5.2).
Croatian: Alogliptin nije ispitivan u bolesnika na peritonejskoj dijalizi (vidjeti dijelove 4.4 i 5.2).
English: Alogliptin has not been studied in patients undergoing peritoneal dialysis (see sections 4.2 and 5.2).
Croatian: Alogliptin nije ispitivan u bolesnika na peritonejskoj dijalizi (vidjeti dijelove 4.2 i 5.2).
English: Alogliptin as add-on therapy to a thiazolidinedione with metformin The addition of 25 mg alogliptin once daily to 30 mg pioglitazone and metformin hydrochloride therapy (mean dose = 1,867.9 mg) resulted in improvements from baseline in HbA1c at Week 52 that were both non-inferior and statistically superior to those produced by 45 mg pioglitazone and metformin hydrochloride therapy (mean dose = 1,847.6 mg, Table 3).
Croatian: Alogliptin kao dodatna terapija tiazolidindionu i metforminu Dodavanje 25 mg alogliptina jedanput na dan terapiji s 30 mg pioglitazona s metforminkloridom (srednja vrijednost doze = 1867,9 mg) dovelo je u 52. tjednu do poboljšanja vrijednosti HbA1c koje se pokazalo neinferiornim i statistički superiornim onome postignutom terapijom s 45 mg pioglitazona s metforminom (srednja vrijednost doze = 1847,6 mg, tablica 3).
English: How to store Vipidia
Croatian: Kako čuvati lijek Vipidia
English: The addition of 25 mg alogliptin once daily to metformin hydrochloride therapy (mean dose = 1,835 mg) resulted in improvements from baseline in HbA1c at Week 52 and Week 104.
Croatian: Dodavanje 25 mg alogliptina jedanput na dan terapiji metaforminkloridom (srednja vrijednost doze = 1835 mg) dovelo je do poboljšanja od početne vrijednosti HbA1c u 52.i 104. tjednu.
English: EU/1/13/844/019 10 film-coated tablets EU/1/13/844/020 14 film-coated tablets EU/1/13/844/021 28 film-coated tablets EU/1/13/844/022 30 film-coated tablets EU/1/13/844/023 56 film-coated tablets EU/1/13/844/024 60 film-coated tablets EU/1/13/844/025 90 film-coated tablets EU/1/13/844/026 98 film-coated tablets EU/1/13/844/027 100 film-coated tablets EU/1/13/844/030 84 film-coated tablets
Croatian: EU/1/13/844/019 10 filmom obloženih tableta EU/1/13/844/020 14 filmom obloženih tableta EU/1/13/844/021 28 filmom obloženih tableta EU/1/13/844/022 30 filmom obloženih tableta EU/1/13/844/023 56 filmom obloženih tableta EU/1/13/844/024 60 filmom obloženih tableta EU/1/13/844/025 90 filmom obloženih tableta EU/1/13/844/026 98 filmom obloženih tableta EU/1/13/844/027 100 filmom obloženih tableta EU/1/13/844/030 84 filmom obloženih tableta
English: In addition, treatment with 25 mg alogliptin once daily resulted in improvements from baseline in HbA1c at Week 52 that were similar to those produced by glipizide (mean dose = 5.4 mg).
Croatian: Dodatno, liječenje s 25 mg alogliptina jedanput na dan dovelo je u 52. tjednu do poboljšanja vrijednosti HbA1c u odnosu na početnu vrijednost koje je bilo slično onom postignutom s glipizidom (srednja vrijednost doze = 5,4 mg).
English: Add-on combination therapy studies Alogliptin 25 mg once daily with metformin vs a sulphonylurea + metformin
Croatian: Ispitivanja dodatka drugim terapijama Alogliptin 25 mg jedanput na dan s metforminom naspram sulfonilureja+metformin
English: Both 25 mg alogliptin alone and in combination with 30 mg pioglitazone demonstrated significant decreases in postprandial glucose and postprandial glucagon whilst significantly increasing postprandial active GLP-1 levels at Week 16 compared to placebo (p<0.05).
Croatian: U 16. tjednu primjene 25 mg alogliptina, samog i u kombinaciji s 30 mg pioglitazona, postigla su se u odnosu na placebo značajna smanjenja postprandijalne glukoze i postprandijalnog glukagona uz značajno povećanje postprandijalnih razina aktivnog GLP-1 (p<0,05).
English: Vipidia 25 mg film-coated tablets Vipidia 12.5 mg film-coated tablets Vipidia 6.25 mg film-coated tablets alogliptin
Croatian: Vipidia 25 mg filmom obložene tablete Vipidia 12,5 mg filmom obložene tablete Vipidia 6,25 mg filmom obložene tablete alogliptin
English: EU/1/13/844/001 10 film-coated tablets EU/1/13/844/002 14 film-coated tablets EU/1/13/844/003 28 film-coated tablets EU/1/13/844/004 30 film-coated tablets EU/1/13/844/005 56 film-coated tablets EU/1/13/844/006 60 film-coated tablets EU/1/13/844/007 90 film-coated tablets EU/1/13/844/008 98 film-coated tablets EU/1/13/844/009 100 film-coated tablets EU/1/13/844/028 84 film-coated tablets
Croatian: EU/1/13/844/001 10 filmom obloženih tableta EU/1/13/844/002 14 filmom obloženih tableta EU/1/13/844/003 28 filmom obloženih tableta EU/1/13/844/004 30 filmom obloženih tableta EU/1/13/844/005 56 filmom obloženih tableta EU/1/13/844/006 60 filmom obloženih tableta EU/1/13/844/007 90 filmom obloženih tableta EU/1/13/844/008 98 filmom obloženih tableta EU/1/13/844/009 100 filmom obloženih tableta EU/1/13/844/028 84 filmom obloženih tableta
English: EU/1/13/844/010 10 film-coated tablets EU/1/13/844/011 14 film-coated tablets EU/1/13/844/012 28 film-coated tablets EU/1/13/844/013 30 film-coated tablets EU/1/13/844/014 56 film-coated tablets EU/1/13/844/015 60 film-coated tablets EU/1/13/844/016 90 film-coated tablets EU/1/13/844/017 98 film-coated tablets EU/1/13/844/018 100 film-coated tablets EU/1/13/844/029 84 film-coated tablets
Croatian: EU/1/13/844/010 10 filmom obloženih tableta EU/1/13/844/011 14 filmom obloženih tableta EU/1/13/844/012 28 filmom obloženih tableta EU/1/13/844/013 30 filmom obloženih tableta EU/1/13/844/014 56 filmom obloženih tableta EU/1/13/844/015 60 filmom obloženih tableta EU/1/13/844/016 90 filmom obloženih tableta EU/1/13/844/017 98 filmom obloženih tableta EU/1/13/844/018 100 filmom obloženih tableta EU/1/13/844/029 84 filmom obloženih tableta
English: Mean change from baseline in fasting plasma glucose at Week 52 for 25 mg alogliptin and metformin was significantly greater than that for glipizide and metformin (p<0.001).
Croatian: Srednja vrijednost promjene od početne vrijednosti glukoze natašte u 52. tjednu bila je za 25 mg alogliptina i metformin značajno veća nego za glipizid i metformin (p<0,001).
English: Hepatobiliary disorders hepatic dysfunction including hepatic failure not known
Croatian: Poremećaji jetre i žuči disfunkcija jetre uključujući zatajenje jetre nepoznato
English: Alogliptin has not been studied in patients with severe hepatic impairment (Child-Pugh score > 9) and is, therefore, not recommended for use in such patients (see sections 4.4 and 5.2).
Croatian: Alogliptin nije ispitan u bolesnika s teškim oštećenjem jetre (Child-Pugh indeks >9) te se stoga u takvih bolesnika njegova primjena ne preporučuje (vidjeti dijelove 4.4 i 5.2).
English: Table 4.
Croatian: PRILOG III.
English: Alogliptin has not been studied in patients with severe hepatic impairment (Child-Pugh score > 9) and is, therefore, not recommended for use in such patients (see sections 4.2 and 5.2).
Croatian: Alogliptin nije ispitan u bolesnika s teškim oštećenjem jetre (Child-Pugh indeks >9) te se stoga u takvih bolesnika njegova primjena ne preporučuje (vidjeti dijelove 4.2 i 5.2).
English: Alogliptin 25 mg once daily with a thiazolidinedione ± metformin or a sulphonylurea (n=195)
Croatian: Alogliptin 25 mg jedanput na dan s tiazolidindionom + metformin ili sulfonilureja (n=195)
English: In patients with moderate or severe renal impairment, or end-stage renal disease on haemodialysis, an increase in systemic exposure to alogliptin of approximately 2- and 4-fold was observed, respectively.
Croatian: U bolesnika s umjerenim ili teškim oštećenjem bubrega, ili završnim stadijem bolesti bubrega na hemodijalizi, opaženo je povećanje sistemske izloženosti alogliptinu od približno 2 i 4 puta. (Bolesnici sa završnim stadijem bolesti bubrega su podvrgnuti hemodijalizi odmah nakon doziranja alogliptina.
English: Not known: - Liver problems such as nausea or vomiting, stomach pain, unusual or unexplained tiredness,
Croatian: • problemi s jetrom poput mučnine ili povraćanja, boli u trbuhu, neobičnog ili neobjašnjivog umora, gubitka teka, tamne mokraće ili žutila kože ili bjeloočnica.
English: In these studies, 2,257 alogliptin-treated patients were ≥ 65 years old and 386 alogliptin-treated patients were ≥ 75 years old.
Croatian: ≥ 65 godina starosti, a 386 bolesnika liječenih alogliptinom imalo je ≥ 75 godina starosti.
English: In addition, mean change from baseline in fasting plasma glucose at Week 52 for 25 mg alogliptin plus 30 mg pioglitazone and metformin was significantly greater than that for 45 mg pioglitazone and metformin (p<0.001).
Croatian: Dodatno, srednja vrijednost promjene od početne vrijednosti glukoze u plazmi natašte bila je u 52. tjednu značajno veća za 25 mg alogliptina s 30 mg pioglitazona i metforminom nego za 45 mg pioglitazona s metforminom (p<0,001).
English: Vipidia 12.5 mg film-coated tablets
Croatian: Vipidia 12,5 mg filmom obložene tablete
English: Do not take Vipidia: - if you are allergic to alogliptin or any of the other ingredients of this medicine (listed in section 6) - if you have had a serious allergic reaction to any other similar medicines that you take to control your blood sugar.
Croatian: • ako ste imali ozbiljnu alergijsku reakciju na neki drugi slični lijek koji uzimate radi kontrole šećera u krvi.
English: What Vipidia looks like and contents of the pack - Vipidia 25 mg film-coated tablets (tablets) are light red, oval (approximately 9.1 mm long by 5.1 mm wide), biconvex, film-coated tablets, with “TAK” and “ALG-25” printed in grey ink on one side.
Croatian: Kako Vipidia izgleda i sadržaj pakiranja - Vipidia 25 mg filmom obložene tablete (tablete) su svijetlocrvene, ovalne (otprilike 9,1 mm duge i 5,1 mm široke), bikonveksne filmom obložene tablete s oznakom „TAK“ i „ALG-25“ otisnutom sivom tintom na jednoj strani.
English: It is used to lower blood sugar levels in adults with type 2 diabetes.
Croatian: Koriste se za snižavanje razina šećera u krvi u odraslih sa šećernom bolešću tipa 2. Šećerna bolest tipa 2 također se zove i dijabetes melitus neovisan o inzulinu.
English: Marketing Authorisation Holder Takeda Pharma A/S Dybendal Alle 10
Croatian: Nositelj odobrenja Takeda Pharma A/S Dybendal Alle 10 2630 Taastrup Danska
English: Vipidia 12.5 mg film-coated tablets Each tablet contains alogliptin benzoate equivalent to 12.5 mg alogliptin.
Croatian: Vipidia 12,5 mg filmom obložene tablete Jedna tableta sadrži 12,5 mg alogliptina u obliku alogliptinbenzoata.
English: Alogliptin 25 mg once daily with a sulphonylurea (n=197)
Croatian: Alogliptin 25 mg jedanput na dan sa sulfonilurejom (n=197)
English: Mean change from baseline in HbA1c (%)† (SE)
Croatian: Srednja promjena od početne vrijednosti HbA1c (%)† (SE)
English: Vipidia 25 mg film-coated tablets
Croatian: Vipidia 25 mg filmom obložene tablete
English: MACE Reported in cardiovascular outcomes study Number of Patients (%)
Croatian: Tablica 4. MACE prijavljeni u ispitivanju kardiovaskularnih ishoda
English: Alogliptin as add-on therapy to insulin (with or without metformin) The addition of 25 mg alogliptin once daily to insulin therapy (mean dose = 56.5 IU, with or without metformin) resulted in statistically significant improvements from baseline in HbA1c and fasting plasma glucose at Week 26 when compared to the addition of placebo (Table 2).
Croatian: Alogliptin kao dodatna terapija inzulinu (s ili bez metformina) Dodavanje 25 mg alogliptina jedanput na dan liječenju inzulinom (srednja vrijednost doze = 56,5 i.j., s ili bez metformina) dovelo je u usporedbi s placebom do statistički značajnog poboljšanja vrijednosti HbA1c i glukoze i plazmi natašte u 26. tjednu u odnosu na početnu vrijednost (tablica 2).
English: Vipidia 6.25 mg film-coated tablets
Croatian: Vipidia 6,25 mg filmom obložene tablete
English: Vipidia 25 mg film-coated tablets Each tablet contains alogliptin benzoate equivalent to 25 mg alogliptin.
Croatian: Vipidia 25 mg filmom obložene tablete Jedna tableta sadrži 25 mg alogliptina u obliku alogliptinbenzoata.
English: More patients receiving 25 mg alogliptin and metformin (48.5%) achieved target HbA1c levels of ≤ 7.0% compared to those receiving glipizide and metformin (42.8%) (p=0.004).
Croatian: Ciljne razine HbA1c od ≤ 7,0% postiglo je više bolesnika koji su primali 25 mg alogliptina s metforminom (48,5%) nego onih koji su primali glipizid s metforminom (42,8%) (p=0,004).
English: NAME OF THE MEDICINAL PRODUCT Vipidia 6.25 mg film-coated tablets Vipidia 12.5 mg film-coated tablets Vipidia 25 mg film-coated tablets
Croatian: Vipidia 6,25 mg filmom obložene tablete Vipidia 12,5 mg filmom obložene tablete Vipidia 25 mg filmom obložene tablete
English: NAME OF THE MEDICINAL PRODUCT Vipidia 12.5 mg tablets alogliptin
Croatian: NAZIV LIJEKA Vipidia 12,5 mg tablete alogliptin
English: Alogliptin 25 mg once daily with a thiazolidinedione + metformin vs a titrating thiazolidinedione + metformin
Croatian: Alogliptin 25 mg jedanput na dan s tiazolidindionom±metformin naspram titrirani tiazolidindion±metformin
English: Takeda Pharma A/S Τηλ: +45 46 77 11 11
Croatian: Τηλ: +45 46 77 11 11
English: NAME OF THE MEDICINAL PRODUCT Vipidia 25 mg tablets alogliptin
Croatian: NAZIV LIJEKA Vipidia 25 mg tablete alogliptin
English: - Vipidia 12.5 mg film-coated tablets (tablets) are yellow, oval (approximately 9.1 mm long by 5.1 mm wide), biconvex, film-coated tablets, with “TAK” and “ALG-12.5” printed in grey ink on one side.
Croatian: - Vipidia 12,5 mg filmom obložene tablete (tablete) su žute, ovalne (otprilike 9,1 mm duge i 5,1 mm široke), bikonveksne filmom obložene tablete s oznakom „TAK“ i „ALG-12.5“ otisnutom sivom tintom na jednoj strani.
English: 30 mg pioglitazone and metformin (33.2%) achieved target HbA1c levels of ≤ 7.0% compared to those receiving 45 mg pioglitazone and metformin (21.3%) at Week 52 (p<0.001).
Croatian: U 52. tjednu je ciljne razine HbA1c od ≤7,0% postiglo značajno više bolesnika koji su primali 25 mg alogliptina s 30 mg pioglitazona i metforminom (33,2%) nego oni koji su primali 45 mg pioglitazona s metforminom (21,3%) (p<0,001).
English: In a pooled analysis of the data from 13 studies, the overall rates of pancreatitis reports in patients treated with 25 mg alogliptin, 12.5 mg alogliptin, active control or placebo were 2, 1, 1 or 0 events per 1,000 patient years, respectively.
Croatian: 25 mg alogliptina, 12,5 mg alogliptina, aktivnom kontrolom ili placebom bile su 2, 1, 1 odnosno 0 događaja na 1000 bolesnik godina.
English: NAME OF THE MEDICINAL PRODUCT Vipidia 6.25 mg tablets alogliptin
Croatian: NAZIV LIJEKA Vipidia 6,25 mg tablete alogliptin
English: Your doctor may want to reduce your dose of sulphonylurea or insulin when you take any of them together with Vipidia in order to avoid too low blood sugar (hypoglycaemia) - if you have kidney disease, you can still take this medicine but your doctor may reduce the dose - if you have liver disease - if you suffer from heart failure - if you are taking insulin or an anti-diabetic medicine, your doctor may want to reduce your dose of the other anti-diabetic medicine or insulin when you take either of them together with Vipidia in order to avoid low blood sugar - if you have or have had a disease of the pancreas
Croatian: Liječnik će možda htjeti sniziti dozu sulfonilureje ili inzulina ako uz bilo koji od njih uzimate lijek Vipidia kako bi se izbjeglo pretjerano sniženje šećera u krvi (hipoglikemija)
English: - Vipidia 6.25 mg film-coated tablets (tablets) are light pink, oval (approximately 9.1 mm long by 5.1 mm wide), biconvex, film-coated tablets, with “TAK” and “ALG-6.25” on printed in grey ink on one side.
Croatian: - Vipidia 6,25 mg filmom obložene tablete (tablete) su svijetloružičaste, ovalne (otprilike 9,1 mm duge i 5,1 mm široke), bikonveksne filmom obložene tablete s oznakom „TAK“ i „ALG-6.25“ otisnutom sivom tintom na jednoj strani.
English: Treatment with 25 mg alogliptin once daily resulted in statistically significant improvements from baseline in HbA1c and fasting plasma glucose compared to placebo-control at Week 26 (Table 2).
Croatian: Liječenje s 25 mg alogliptina jedanput na dan dovelo je u usporedbi s kontrolnom skupinom do statistički značajnih poboljšanja vrijednosti HbA1c i glukoze u plazmi natašte u 26. tjednu u odnosu na početnu vrijednost (tablica 2).
English: Patients with kidney disease
Croatian: Osobe s bolešću bubrega
English: Therefore, no dose adjustment is necessary for patients with mild to moderate hepatic impairment (Child-Pugh scores of 5 to 9).
Croatian: Stoga u bolesnika s blagim do umjerenim oštećenjem jetre (Child-Pugh indeks 5 do 9) nije potrebna prilagodba doze.
English: The addition of 25 mg alogliptin once daily to metformin hydrochloride therapy (mean dose = 1,847 mg) resulted in statistically significant improvements from baseline in HbA1c and fasting plasma glucose at Week 26 when compared to the addition of placebo (Table 2).
Croatian: Dodavanje 25 mg alogliptina jedanput na dan terapiji metforminkloridom (srednja vrijednost doze = 1847 mg) dovelo je u usporedbi s placebom do statistički značajnih poboljšanja vrijednosti HbA1c i glukoze u plazmi natašte u 26. tjednu u odnosu na početnu vrijednost (tablica 2).
English: The addition of 25 mg alogliptin once daily to glyburide therapy (mean dose = 12.2 mg) resulted in statistically significant improvements from baseline in HbA1c at Week 26 when compared to the addition of placebo (Table 2).
Croatian: Dodavanje 25 mg alogliptina jedanput na dan terapiji gliburidom (srednja vrijednost doze = 12,2 mg) dovelo je u usporedbi s placebom do statistički značajnog poboljšanja vrijednosti HbA1c u 26. tjednu u odnosu na početnu vrijednost (tablica 2).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 12.5 mg alogliptin (as benzoate).
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna tableta sadrži 12,5 mg alogliptina (u obliku alogliptinbenzoata).
English: Warnings and precautions Talk to your doctor or pharmacist before taking Vipidia: - if you have type 1 diabetes (your body does not produce insulin) - if you have diabetic ketoacidosis (a complication of diabetes that occurs when the body is unable to breakdown glucose because there is not enough insulin).
Croatian: • ako imate dijabetičku ketoacidozu (komplikaciju šećerne bolesti koja se javlja kad se zbog nedostatka inzulina glukoza u tijelu ne može razgraditi).
English: Alogliptin as add-on therapy to a thiazolidinedione The addition of 25 mg alogliptin once daily to pioglitazone therapy (mean dose = 35.0 mg, with or without metformin or a sulphonylurea) resulted in statistically significant improvements from baseline in HbA1c and fasting plasma glucose at Week 26 when compared to the addition of placebo (Table 2).
Croatian: Dodavanje 25 mg alogliptina jedanput na dan terapiji pioglitazonom (srednja vrijednost doze = 35,0 mg, s ili bez metformina ili sulfonilureje) dovelo je u usporedbi s placebom do statistički značajnog poboljšanja vrijednosti HbA1c i glukoze u plazmi natašte u 26. tjednu u odnosu na početnu vrijednost (tablica 2).
English: Yellow, oval (approximately 9.1 mm long by 5.1 mm wide), biconvex, film-coated tablets with “TAK” and “ALG-12.5” printed in grey ink on one side.
Croatian: Žute, ovalne (približno 9,1 mm duge i 5,1 mm široke), bikonveksne filmom obložene tablete s oznakom „TAK“ i „ALG-12.5“ otisnutom sivom tintom na jednoj strani.
English: Each 25 mg tablet contains alogliptin benzoate equivalent to 25 mg alogliptin, - The other ingredients are: mannitol, microcrystalline cellulose, hydroxypropylcellulose, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide (E171), red iron oxide (E172), macrogol 8000, shellac and black iron oxide (E172).
Croatian: - Drugi sastojci su: manitol, mikrokristalična celuloza, hidroksipropilceluloza, umrežena karmelozanatrij, magnezijev stearat, hipromeloza, titanijev dioksid (E171), crveni željezov oksid (E172), makrogol 8000, šelak i crni željezov oksid (E172).
English: More patients receiving 25 mg alogliptin (7.8%) achieved target HbA1c levels of ≤ 7.0% compared to those receiving placebo (0.8%) at Week 26.
Croatian: U 26. tjednu je ciljne razine HbA1c od ≤7,0% postiglo više bolesnika koji su primali 25 mg alogliptina (7,8%) nego oni koji su primali placebo (0,8%) (p<0,001).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 6.25 mg alogliptin (as benzoate).
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna tableta sadrži 6,25 mg alogliptina (u obliku alogliptinbenzoata).
English: Treatment-corrected change from baseline in HbA1c (%)†
Croatian: Promjena od početne vrijednosti HbA1c korigirana za liječenje (%)† (1-strani CI)