natgillin/translations-raw huggingface dataset:
Therapy may be restarted no earlier than 48 hours following surgery or resumption of oral nutrition and provided that renal function has been re-evaluated and found to be stable. 
S terapijom se smije ponovno započeti tek nakon što je od kirurškog zahvata ili ponovne uspostave peroralne prehrane prošlo najmanje 48 sati i pod uvjetom da je funkcija bubrega bila ponovno procijenjena i da je potvrđeno da je stabilna.
After once daily dosing of 5 mg linagliptin, steady-state plasma concentrations are reached by the third dose. 
Nakon jednokratnog dnevnog doziranja 5 mg linagliptina stanje dinamičke ravnoteže koncentracije u plazmi se postiže trećom dozom.
Some patients have experienced the following side effects while taking Jentadueto with insulin - Uncommon: liver function disorders, constipation 
Neki bolesnici su imali sljedeće nuspojave tijekom uzimanja Jentadueta s inzulinom - Manje često: poremećaji jetrene funkcije, zatvor
Hazard Ratio 
Omjer hazarda
It is not known whether linagliptin passes into human milk. 
Nije poznato prolazi li linagliptin u majčino mlijeko.
When renal function is impaired, renal clearance is decreased in proportion to that of creatinine and thus the elimination half-life is prolonged, leading to increased levels of metformin hydrochloride in plasma. 
Kada je bubrežna funkcija oštećena, bubrežni klirens je smanjen proporcionalno klirensu kreatinina i stoga je poluvijek eliminacije produljen, dovodeći do povišenih razina metforminklorida u plazmi.
In placebocontrolled studies, more than 1800 patients were treated with the therapeutic dose of either 2.5 mg linagliptin twice daily (or its bioequivalent of 5 mg linagliptin once daily) in combination with metformin for ≥ 12/24 weeks. 
U placebom kontroliranim ispitivanjima više od 1800 bolesnika bilo je liječeno terapijskom dozom od 2,5 mg linagliptina dvaput dnevno (ili njegovim bioekvivalentom od 5 mg linagliptina jedanput dnevno) u kombinaciji s metforminom u trajanju ≥ 12/24 tjedna.
In vitro assessment of interactions 
Procjena interakcija lijeka in vitro
When linagliptin and metformin were administered in combination with a sulphonylurea, hypoglycaemia was the most frequently reported adverse event (linagliptin plus metformin plus sulphonylurea 23.9% and 16.0% in placebo plus metformin plus sulphonylurea). 
Kada su se linaglitptin i metformin primijenili u kombinaciji sa sulfonilurejom, hipoglikemija je bila najčešće prijavljen štetni događaj (linagliptin plus metformin plus sulfonilureja 23,9% i 16,0% u skupini placebo plus metformin plus sulfonilureja).
Hypoglycaemia is not identified as adverse reaction for linagliptin, metformin, or linagliptin plus metformin. 
Hipoglikemija nije utvrđena kao nuspojava linagliptina, metformina ili kombinacije linagliptin plus metformin.
Liver, kidneys, stomach, reproductive organs, thymus, spleen, and lymph nodes were target organs of toxicity in Cynomolgus monkeys at more than 450 times human exposure. 
Jetra, bubrezi, želudac, reproduktivni organi, timus, slezena i limfni čvorovi bili su ciljni organi toksičnosti kod cynomolgus majmuna pri dozama 450 puta višima nego kod izloženosti u ljudi.
90 x 1 film-coated tablets. 
60 x 1 filmom obložena tableta.
When linagliptin plus metformin hydrochloride is used in combination with insulin, a lower dose of insulin may be required to reduce the risk of hypoglycaemia (see section 4.4). 
Kada se kombinacija linagliptin plus metforminklorid primjenjuje zajedno s inzulinom, može biti potrebna niža doza inzulina radi smanjenja rizika od hipoglikemije (vidjeti dio 4.4).
Animal studies with metformin do not indicate harmful effects with respect to reproductive toxicity (see section 5.3). 
Ispitivanja metformina na životinjama ne ukazuju na štetne učinke na reprodukciju (vidjeti dio 5.3).
Linagliptin as add-on to a combination of metformin and sulphonylurea therapy A placebo-controlled study of 24 weeks in duration was conducted to evaluate the efficacy and safety of linagliptin 5 mg to placebo, in patients not sufficiently treated with a combination with metformin and a sulphonylurea. 
Linagliptin kao dodatak kombiniranom liječenju metforminom i sulfonilurejom Provedeno je placebom kontrolirano ispitivanje u trajanju od 24 tjedna u svrhu ocjene djelotvornosti i sigurnosti linagliptina od 5 mg, u odnosu na placebo, kod bolesnika koji nisu dostatno liječeni kombinacijom metformina i sulfonilureje.
When linagliptin was added to a sulphonylurea on a background of metformin, the incidence of hypoglycaemia was increased over that of placebo. 
Kada se na osnovno liječenje metforminom dodao linagliptin uz sulfonilureju, povećala se incidencija hipoglikemije u odnosu na placebo.
When linagliptin plus metformin hydrochloride is used in combination with a sulphonylurea, a lower dose of the sulphonylurea may be required to reduce the risk of hypoglycaemia (see section 4.4). 
Kada se linagliptin plus metforminklorid primjenjuje u kombinaciji sa sulfonilurejom, može se razmotriti niža doza sulfonilureje kako bi se smanjio rizik od hipoglikemije (vidjeti dio 4.4).
PHARMACEUTICAL FORM AND CONTENTS Multipack comprising 2 packs, each containing 60 x 1 film-coated tablets Multipack comprising 2 packs, each containing 90 x 1 film-coated tablets Multipack comprising 2 packs, each containing 100 x 1 film-coated tablets 
Višestruko pakiranje koje sadrži 2 pakiranja, svako sa 60 x 1 filmom obloženom tabletom Višestruko pakiranje koje sadrži 2 pakiranja, svako sa 90 x 1 filmom obloženom tabletom Višestruko pakiranje koje sadrži 2 pakiranja, svako sa 100 x 1 filmom obloženom tabletom
Linagliptin trough concentrations were also measured in elderly (age ≥ 70 years) with type 2 diabetes in a phase III study of 24 weeks duration. 
Koncentracije linagliptina na kraju dozirnog intervala bile su također mjerene na starijim osobama (dob ≥ 70 godina) s dijabetesom tipa 2 u fazi III ispitivanja u trajanju 24 tjedna.
In the pooled analysis of the seven placebo-controlled trials, the overall incidence of adverse events in patients treated with placebo and metformin was comparable to that seen with linagliptin 2.5 mg and metformin (54.3 and 49.0%). 
U združenoj analizi sedam placebom kontroliranih ispitivanja, ukupna incidencija štetnih događaja u bolesnika liječenih placebom i metforminom bila je slična skupini na linagliptinu 2,5 mg i metforminu (54,3% i 49,0%).
Number of patients Primary CV composite (Cardiovascular death, non-fatal MI, non-fatal stroke) 
Broj bolesnika Primarna KV kompozitna mjera (kardiovaskularna smrt, MI bez smrtnog ishoda, moždani udar bez smrtnog ishoda) Mortalitet zbog svih uzroka
When Jentadueto is used with a sulphonylurea medicine or with insulin, low blood sugar can occur and your doctor may reduce the dose of your sulphonylurea or insulin. 
Kada se Jentadueto primjenjuje sa sulfonilurejom ili inzulinom može doći do niskih vrijednosti šećera u krvi te Vam liječnik može sniziti dozu sulfonilureje ili inzulina.
Use of DPP-4 inhibitors has been associated with a risk of developing acute pancreatitis. 
Upotreba Jentadueta povezana je s rizikom od razvoja akutnog pankreatitisa.
Bottle: Keep the bottle tightly closed in order to protect from moisture. 
Boca: Bocu čuvati čvrsto zatvorenu radi zaštite od vlage.
Renal clearance at steady-state was approximately 70 ml/min. 
Bubrežni klirens je pri stanju dinamičke ravnoteže bio oko 70 ml/min.
Investigations Amylase increased uncommon 
Pretrage Povišena amilaza manje često
Metformin is excreted in human milk in small amounts. 
Metformin se izlučuje u majčino mlijeko u ljudi u malim količinama.
Lactic acidosis is characterised by acidotic dyspnea, abdominal pain, muscle cramps, asthenia and hypothermia followed by coma. 
Značajke laktacidoze su acidozna dispneja, bol u abdomenu, grčevi u mišićima, astenija i hipotermija nakon koje slijedi koma.
Caution should be exercised in patients with a history of pancreatitis. 
Potreban je oprez u bolesnika s pankreatitisom u anamnezi.
Linagliptin cardiovascular safety study (CAROLINA) CAROLINA was a randomized study in 6033 patients with early type 2 diabetes and increased CV risk or established complications who were treated with linagliptin 5 mg (3023) or glimepiride 1-4mg (3010) added to standard of care (including background therapy with metformin in 83% of patients) targeting regional standards for HbA1c and CV risk factors. 
Ispitivanje kardiovaskularne sigurnosti primjene linagliptina (CAROLINA) CAROLINA je bila randomizirano ispitivanje u 6033 bolesnika s ranim dijabetesom tipa 2 i povećanim kardiovaskularnim rizikom ili utvrđenim komplikacijama koji su bili liječeni linagliptinom 5 mg (3023) ili glimepiridom 1 - 4 mg (3010) dodanim uz standardno liječenje (uključujući osnovnu terapiju metforminom u 83% bolesnika) s ciljem postizanja regionalnih standarda za HbA1c i kardiovaskularne faktore rizika.
The efficacy and safety of linagliptin 2.5 mg twice daily versus 5 mg once daily in combination with metformin in patients with insufficient glycaemic control on metformin monotherapy was evaluated in a double-blind placebo-controlled study of 12 weeks duration. 
Djelotvornost i sigurnost linagliptina 2,5 mg dvaput dnevno naspram 5 mg jedanput dnevno u kombinaciji s metforminom u bolesnika s nedostatnom kontrolom glikemije na monoterapiji metforminom bila je ocijenjena u dvostruko slijepom placebom kontroliranom ispitivanju u trajanju od 12 tjedana.
The dose of Jentadueto should provide linagliptin dosed as 2.5 mg twice daily (5 mg total daily dose) and a dose of metformin similar to the dose already being taken. 
Doza Jentadueta mora osigurati linagliptin u dozi od 2,5 mg dvaput dnevno (ukupna dnevna doza 5 mg) i dozu metformina sličnu dozi koja se već uzima.
In rats, effects on reproductive organs, thyroid and the lymphoid organs were seen at more than 1500 times human exposure. 
Kod štakora, učinci na reproduktivne organe, štitnjaču i limfoidne organe primijećeni su pri dozama preko 1500 puta višima nego kod izloženosti u ljudi.
The steady-state pharmacokinetics of 5 mg linagliptin were not changed by concomitant administration of a single 1.75 mg dose glibenclamide (glyburide). 
Farmakokinetika 5 mg linagliptina u stanju dinamičke ravnoteže nije se promijenila uslijed istodobne primjene jednokratne doze od 1,75 mg glibenklamida (gliburid).
Adverse reactions reported in patients who received linagliptin+metformin alone (as mono-components or in combination) or as add-on to other anti-diabetic therapies in clinical trial and from post-marketing experience 
Tablica 2: Nuspojave prijavljene u bolesnika koji su primali linagliptin+metformin kao monoterapiju (kao pojedinačne komponente ili u kombinaciji) ili kao dodatnu terapiju uz druge antidijabetičke terapije u kliničkim ispitivanjima te iz iskustva nakon stavljanja lijeka u promet
• Inhibitors of OCT1 (such as verapamil) may reduce efficacy of metformin. 
• inhibitorima OCT1 (kao što je verapamil) može smanjiti djelotvornost metformina.
Linagliptin is a P-glycoprotein substrate, and inhibits P-glycoprotein mediated transport of digoxin with low potency. 
Linagliptin je P-glikoproteinski supstrat koji s niskom potentnošću inhibira prijenos digoksina posredovan P-glikoproteinom.
Co-administration of a single 5 mg oral dose of linagliptin and multiple 200 mg oral doses of ritonavir, a potent inhibitor of P-glycoprotein and CYP3A4, increased the AUC and Cmax of linagliptin approximately twofold and threefold, respectively. 
Istovremena primjena jednokratne oralne doze 5 mg linagliptina i višekratnih oralnih doza 200 mg ritonavira, snažnog inhibitora P-glikoproteina i CYP3A4, povećala je AUC i Cmax linagliptina oko dva, odnosno tri puta.
Linagliptin also showed significant improvements in patients achieving a target HbA1c of < 7.0% (31.2% on linagliptin versus 9.2% on placebo), and also for fasting plasma glucose (FPG) with -12.7 mg/dl reduction compared to placebo. 
Linagliptin je također pokazao značajna poboljšanja u bolesnika koji su postigli ciljni HbA1c od < 7,0% (31,2% u skupini na linagliptinu naspram 9,2% u skupini na placebu) i također za razinu glukoze u plazmi natašte (FPG) sa smanjenjem od -12,7 mg/dl u usporedbi sa skupinom na placebu.
Co-administration of multiple oral doses of 5 mg linagliptin and a single oral dose of 1.75 mg glibenclamide (glyburide) resulted in clinically not relevant reduction of 14% of both AUC and Cmax of glibenclamide. 
Istovremena primjena višekratnih oralnih doza od 5 mg linagliptina i jednokratne oralne doze 1,75 mg glibenklamida (gliburid) rezultirala je klinički neznačajnim smanjenjem i AUC i Cmax glibenklamida za 14%.
In a 24-week placebo-controlled factorial study of initial therapy, linagliptin 2.5 mg twice daily in combination with metformin (500 mg or 1,000 mg twice daily) provided significant improvements in glycaemic parameters compared with either monotherapy as summarised in Table 3 (mean baseline HbA1c 8.65%). 
U placebom kontroliranom faktorijalnom ispitivanju početne terapije u trajanju 24 tjedna, linagliptin 2,5 mg dvaput dnevno u kombinaciji s metforminom (500 mg ili 1000 mg dvaput dnevno) pružio je značajna poboljšanja parametara glikemije u usporedbi s bilo kojom monoterapijom kao što je opisano u tablici 3 (prosječna početna vrijednost HbA1c 8,65%).
In the treated population, severe hypoglycaemic events (requiring assistance) were reported in 3.0% of patients on linagliptin and in 3.1% on placebo. 
U liječenoj populaciji, događaji teške hipoglikemije (koji su zahtijevali pomoć) bili su prijavljeni u 3,0% bolesnika koji su primali linagliptin i u 3,1% bolesnika koji su primali placebo.
If bullous pemphigoid is suspected, Jentadueto should be discontinued. 
Ako se sumnja na bulozni pemfigoid, potrebno je prekinuti liječenje lijekom Jentadueto.
The mean HbA1c at baseline was 7.15%. 
Srednja vrijednost HbA1c na početku ispitivanja iznosila je 7,15%.
Linagliptin also showed significant improvements in fasting plasma glucose (FPG) by -21.1 mg/dl and 2-hour postprandial glucose (PPG) by -67.1 mg/dl compared to placebo, as well as a greater portion of patients achieving a target HbA1c of < 7.0% (28.3% on linagliptin versus 11.4% on placebo). 
Linagliptin je također pokazao značajna poboljšanja glukoze u plazmi natašte (FPG) za -21,1 mg/dl i postprandijalnoj razini glukoze 2 sata nakon obroka (PPG) za -67,1 mg/dl u usporedbi s placebom, a ujedno je veći udio bolesnika postigao ciljni HbA1c od < 7,0% (28,3% u skupini na linagliptinu naspram 11,4% u skupini na placebu).
In a cardiovascular and renal safety study (CARMELINA) with median observation period of 2.2 years, adjudicated acute pancreatitis was reported in 0.3% of patients treated with linagliptin and in 0.1% of patients treated with placebo. 
Tijekom ispitivanja sigurnosti primjene za kardiovaskularni sustav i bubrege (CARMELINA) uz medijan razdoblja promatranja od 2,2 godine, ustanovljeni akutni pankreatitis bio je prijavljen u 0,3% bolesnika liječenih linagliptinom te u 0,1% bolesnika koji su primali placebo.
Infections and infestations Nasopharyngitis uncommon 
Infekcije i infestacije Nazofaringitis manje često
Glycaemic parameters at final visit (24-week study) for linagliptin and metformin, alone and in combination in patients with type 2 diabetes mellitus inadequately controlled on diet and exercise 
Tablica 3: Parametri glikemije pri završnom posjetu (ispitivanje u trajanju 24 tjedna) za linagliptin i metformin, u obliku monoterapije i u kombinaciji u bolesnika s dijabetes melitusom tipa 2 u kojih nije postignuta odgovarajuća kontrola dijetom i tjelesnom aktivnošću.
Bottle Keep the bottle tightly closed in order to protect from moisture. 
Boca Bocu čuvati čvrsto zatvorenu radi zaštite od vlage.
Effects of other medicinal products on linagliptin Clinical data described below suggest that the risk for clinically meaningful interactions by coadministered medicinal products is low. 
U nastavku opisani klinički podaci ukazuju da je rizik od klinički značajnih interakcija u istovremenoj primjeni lijekova nizak.
10 x 1 film-coated tablets 14 x 1 film-coated tablets 28 x 1 film-coated tablets 30 x 1 film-coated tablets 56 x 1 film-coated tablets 60 x 1 film-coated tablets 84 x 1 film-coated tablets 90 x 1 film-coated tablets 98 x 1 film-coated tablets 100 x 1 film-coated tablets 120 x 1 film-coated tablets 
10 x 1 filmom obložena tableta 14 x 1 filmom obložena tableta 28 x 1 filmom obložena tableta 30 x 1 filmom obložena tableta 56 x 1 filmom obložena tableta 60 x 1 filmom obložena tableta 84 x 1 filmom obložena tableta 90 x 1 filmom obložena tableta 98 x 1 filmom obložena tableta 100 x 1 filmom obložena tableta 120 x 1 filmom obložena tableta
In a pooled analysis of elderly (age ≥ 70 years) patients with type 2 diabetes (n=183) who were taking both metformin and basal insulin as background therapy, linagliptin in combination with metformin plus insulin provided significant improvements in HbA1c parameters with -0.81% (CI: -1.01; -0.61) adjusted mean change from baseline (mean baseline HbA1c 8.13%) compared to placebo in combination with metformin plus insulin. 
U združenoj analizi starijih bolesnika (dob ≥ 70 godina) s dijabetesom tipa 2 (n=183) koji su uzimali i metformin i bazalni inzulin kao osnovnu terapiju, kombinacija linagliptina i metformina plus inzulin pružila je značajna poboljšanja za parametre HbA1c, s prilagođenom prosječnom promjenom od -0,81% (CI: -1,01; -0,61) u odnosu na početnu vrijednost (prosječna početna vrijednost HbA1c 8,13%), u usporedbi s placebom u kombinaciji s metforminom plus inzulin.
In one study linagliptin was given as add-on to metformin plus sulphonylurea. 
U jednom ispitivanju linaglitin se davao kao dodatna terapija uz metformin plus sulfonilureja.
Acute pancreatitis has been observed in patients taking linagliptin. 
Bulozni pemfigoid opažen je u bolesnika koji uzimaju linagliptin.
The efficacy and safety of linagliptin in combination with metformin in patients with insufficient glycaemic control on metformin monotherapy was evaluated in a double-blind placebo-controlled study of 24 weeks duration. 
Djelotvornost i sigurnost linagliptina u kombinaciji s metforminom u bolesnika s nedostatnom kontrolom glikemije na monoterapiji metforminom bila je ocijenjena u dvostruko slijepom, placebom kontroliranom ispitivanju u trajanju od 24 tjedna.
How to take Jentadueto 
Kako uzimati Jentadueto
INFORMATION IN BRAILLE Jentadueto 2.5 mg/850 mg 
16. PODACI NA BRAILLEOVOM PISMU Jentadueto 2,5 mg/850 mg
Co-administration of multiple daily doses of 5 mg linagliptin with multiple doses of 0.25 mg digoxin had no effect on the pharmacokinetics of digoxin in healthy subjects. 
Istovremena primjena višekratnih dnevnih doza 5 mg linagliptina s višekratnim dozama 0,25 mg digoksina nije imala učinak na farmakokinetiku digoksina u zdravih ispitanika.
Co-administration of multiple three-times-daily doses of 850 mg metformin hydrochloride with 10 mg linagliptin once daily did not clinical meaningfully alter the pharmacokinetics of linagliptin in healthy subjects. 
Istovremena primjena višekratnih doza metforminklorida od 850 mg tri puta dnevno s 10 mg linagliptina jedanput dnevno nije klinički značajno promijenila farmakokinetiku linagliptina u zdravih ispitanika.
System organ class Adverse reaction 
Klasifikacija organskih sustava Nuspojava
- High-Density PolyEthylene (HDPE) bottle with plastic screw cap and a seal liner (aluminiumpolyester foil laminate) and a silica gel desiccant. 
- Boca od polietilena visoke gustoće (HDPE) s plastičnim zatvaračem na navoj i zaštitnom folijom (aluminijsko poliesterska višeslojna folija) te silikagelom kao sredstvom za sušenje.
Among patients who were using insulin at baseline, the incidence of severe hypoglycaemia was 4.4% in linagliptin-treated patients and 4.9% in placebo treated patients. 
Među bolesnicima koji su od početka ispitivanja primjenjivali inzulin, incidencija teške hipoglikemije iznosila je 4,4% u bolesnika liječenih linagliptinom te 4,9% u bolesnika koji su primali placebo.
Linagliptin cardiovascular and renal safety study (CARMELINA) The CARMELINA study evaluated the cardiovascular and renal safety of linagliptin versus placebo in patients with type 2 diabetes and with increased CV risk evidenced by a history of established macrovascular or renal disease (see section 5.1). 
U ispitivanju CARMELINA ocijenjena je sigurnost primjene linagliptina za kardiovaskularni sustav i bubrege naspram placeba u bolesnika s dijabetesom tipa 2 i povećanim kardiovaskularnim rizikom dokazanim na temelju utvrđene makrovaskularne ili bubrežne bolesti u anamnezi (vidjeti dio 5.1).
Posology for renally impaired patients GFR ml/min Metformin 
Tablica 1: Doziranje za bolesnike s oštećenjem bubrega GFR ml/min Metformin
For the different doses of metformin, Jentadueto is available in strengths of 2.5 mg linagliptin plus 850 mg metformin hydrochloride and 2.5 mg linagliptin plus 1,000 mg metformin hydrochloride. 
Za različite doze metformina, Jentadueto je dostupan u jačinama od 2,5 mg linagliptina plus 850 mg metforminklorida i 2,5 mg linagliptina plus 1000 mg metforminklorida.
- Pack sizes of 10 x 1, 14 x 1, 28 x 1, 30 x 1, 56 x 1, 60 x 1, 84 x 1, 90 x 1, 98 x 1, 100 x 1 and 120 x 1 film-coated tablets and multipacks containing 120 (2 packs of 60 x 1), 180 (2 packs of 90 x 1) and 200 (2 packs of 100 x 1) film-coated tablets in aluminium lidding foil and PVC/polychlorotrifluoro ethylene/PVC based forming foil perforated unit dose blisters. 
- Veličine pakiranja od 10 x 1, 14 x 1, 28 x 1, 30 x 1, 56 x 1, 60 x 1, 84 x 1, 90 x 1, 98 x 1, 100 x 1 i 120 x 1 filmom obloženih tableta i višestruka pakiranja koja sadrže 120 (2 pakiranja od 60 x 1), 180 (2 pakiranja od 90 x 1) i 200 (2 pakiranja od 100 x 1) filmom obloženih tableta u perforiranim blisterima djeljivim na jedinične doze od aluminijske pokrovne folije i bazne folije od PVC/poliklorotrifluoroetilen/PVC-a.
Lactic acidosis very rare 
Laktacidoza vrlo rijetko
Linagliptin cardiovascular and renal safety study (CARMELINA) CARMELINA was a randomized study in 6979 patients with type 2 diabetes with increased CV risk evidenced by a history of established macrovascular or renal disease who were treated with linagliptin 5 mg (3494) or placebo (3485) added to standard of care targeting regional standards for HbA1c, CV risk factors and renal disease. 
CARMELINA je bilo randomizirano ispitivanje u 6979 bolesnika s dijabetesom tipa 2 i povećanim kardiovaskularnim (KV) rizikom dokazanim na temelju utvrđene makrovaskularne ili bubrežne bolesti u anamnezi koji su bili liječeni linagliptinom 5 mg (3494) ili placebom (3485) dodanima standardnom liječenju usmjerenom na postizanje lokalno važećih standarda za HbA1c, KV faktore rizika i bubrežnu bolest.
Linagliptin in combination with metformin plus insulin provided significant improvements in HbA1c in this subgroup with -0.68% (CI: -0.78; -0,57) adjusted mean change from baseline (mean baseline HbA1c 8.28%) compared to placebo in combination with metformin plus insulin. 
Linagliptin u kombinaciji s metforminom plus inzulin doveo je do značajnih poboljšanja HbA1c u ovoj podskupini, s prilagođenom prosječnom promjenom od -0,68% (CI: -0,78; -0,57) u odnosu na početnu vrijednost (prosječna početna vrijednost HbA1c 8,28%) u usporedbi s placebom u kombinaciji s metforminom plus inzulin.
• a significant reduction of the absolute risk of any diabetes-related complication in the metformin group (29.8 events/1,000 patient-years) versus diet alone (43.3 events/1,000 patient-years), p=0.0023, and versus the combined sulphonylurea and insulin monotherapy groups (40.1 events/1,000 patient-years), p=0.0034, 
• Značajno smanjenje apsolutnog rizika od svih dijabetičkih komplikacija u skupini koja je uzimala metformin (29,8 događaja /1000 bolesnik-godina) naspram skupine koja je bila samo na dijeti (43,3 događaja/1000 bolesnik-godina), p=0,0023, i naspram skupina liječenih sulfonilurejom i inzulinom kao monoterapijom (40,1 događaja/1000 bolesnik-godina), p=0,0034,
• a significant reduction of the absolute risk of any diabetes-related mortality: metformin 7.5 events/1,000 patient-years, diet alone 12.7 events/1,000 patient-years, p=0.017, 
• Značajno smanjenje apsolutnog rizika od smrtnosti povezane s dijabetesom: metformin 7,5 događaja/1000 bolesnik-godina, samo dijeta 12,7 događaja/1000 bolesnik-godina, p=0,017,