natgillin/translations-raw huggingface dataset:
Nogle patienter har haft overfølsomhedsreaktioner (hyppigheden er ikke almindelig (kan forekomme hos op til 1 ud af 100 personer), når Trajenta tages alene eller i kombination med andre lægemidler til behandling af sukkersyge, herunder hvæsende vejrtrækning og åndenød (bronkial hyperreaktivitet; hyppighed ikke kendt (kan ikke estimeres ud fra forhåndenværende data)). 
Some patients have experienced allergic reactions (hypersensitivity; frequency uncommon, may affect up to 1 in 100 people) while taking Trajenta alone or in combination with other medicinal products for the treatment of diabetes, which may be serious, including wheezing and shortness of breath (bronchial hyperreactivity; frequency not known, frequency cannot be estimated from the available data).
Orale kontraceptiva: Samtidig administration af 5 mg linagliptin ændrede ikke steady statefarmakokinetikken af levonorgestrel eller ethinylestradiol. 
Oral contraceptives: co-administration with 5 mg linagliptin did not alter the steady-state pharmacokinetics of levonorgestrel or ethinylestradiol.
Linagliptin som tillæg til metformin 
Linagliptin as add-on to metformin therapy
Forekomsten af bivirkninger (f.eks. hypoglykæmi) er afhængig af baggrundsbehandlingen, og bivirkninger er derfor analyseret for de enkelte behandlingsregimer (monoterapi, tillægsbehandling til metformin, til metformin plus sulfonylurinstof og til insulin). 
Due to the impact of the background therapy on adverse reactions (e.g. on hypoglycaemias), adverse reactions were analysed based on the respective treatment regimens (monotherapy, add-on to metformin, add-on to meformin plus sulphonylurea, and add-on to insulin).
Lever, nyrer og mave-tarm-kanalen var de primære målorganer for toksisk påvirkning i mus og rotter ved gentagne doser af linagliptin på mere end 300 gange den humane eksponering. 
Liver, kidneys and gastrointestinal tract are the principal target organs of toxicity in mice and rats at repeat doses of linagliptin of more than 300 times the human exposure.
Pakningsstørrelserne er 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 og 120 x 1 tabletter. 
The pack sizes are 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 tablets.
Linagliptin alene har sammenlignelig forekomst af hypoglykæmi som placebo. 
Linagliptin alone showed a comparable incidence of hypoglycaemia to placebo.
Sulfonylurinstoffer: Steady state-farmakokinetikken for linagliptin 5 mg blev ikke påvirket af samtidig administration af en enkelt dosis af 1,75 mg glibenclamid (glyburid). 
Sulphonylureas: the steady-state pharmacokinetics of 5 mg linagliptin was not changed by concomitant administration of a single 1.75 mg dose glibenclamide (glyburide).
Linagliptin som tillæg til insulinbehandling 
Linagliptin as add-on to insulin therapy
• Trajenta 5 mg er runde, lyserøde, filmovertrukne tabletter på 8 mm, præget med henholdsvis 
• Trajenta 5 mg tablets are 8 mm diameter round, light red film-coated tablets debossed with
Den hyppigst rapporterede bivirkning observeret under trestof-kombinationsbehandlingen linagliptin plus metformin plus sulfonylurinstof var hypoglykæmi med 14,8 % mod 7,6 % for placebo. 
The most frequently reported adverse reaction was “hypoglycaemia” observed under the triple combination, linagliptin plus metformin plus sulphonylurea 14.8% versus 7.6% in placebo.
Betændelse i bugspytkirtlen (pankreatitis) er set hos nogle patienter (hyppighed sjælden, kan forekomme hos op til 1 ud af 1.000 personer), når Trajenta tages alene eller i kombination med andre lægemidler til behandling af sukkersyge. 
Some patients have experienced inflammation of the pancreas (pancreatitis; frequency rare, may affect up to 1 in 1000 people) while taking Trajenta alone or in combination with other medicinal products for the treatment of diabetes.
Warfarin: Gentagne daglige doser af 5 mg linagliptin og en enkelt dosis af S(-)- eller R(+)-warfarin, et CYP2C9-substrat, ændrede ikke farmakokinetikken af warfarin. 
Warfarin: multiple daily doses of 5 mg linagliptin did not alter the pharmacokinetics of S(-) or R(+) warfarin, a CYP2C9 substrate, administered in a single dose.
Boehringer Ingelheim RCV GmbH & Co KG Viena - Sucursala Bucuresti Tel: +40 21 302 28 00 
Boehringer Ingelheim RCV GmbH & Co KG Viena - Sucursala Bucureşti Tel: +40 21 302 28 00
Antal patienter Primært sammensat kardiovaskulært (kardiovaskulær mortalitet, ikke dødeligt MI, ikkedødelig apopleksi) Mortalitet uanset årsag 
Number of patients Primary CV composite (Cardiovascular death, non-fatal MI, non-fatal stroke)
Hver filmovertrukket tablet (tablet) indeholder 5 mg linagliptin 
Each film-coated tablet (tablet) contains 5 mg of linagliptin
Linagliptin er derfor ikke en in vivo-inhibitor af P-glykoproteinmedieret transport. 
Therefore, linagliptin is not an inhibitor of P-glycoprotein-mediated transport in vivo.
De nedenfor beskrevne kliniske data tyder på, at risikoen for klinisk betydningsfulde interaktioner med samtidigt administrerede lægemidler er lav. 
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.
NOAEL for toksicitet i moderdyret, embryoføtal toksicitet og toksicitet i afkommet hos rotter var 49 gange den humane eksponering. 
The NOAEL for maternal-, embryo-fetal-, and offspring toxicity in rats was 49 times human exposure.
NOAEL (niveauet uden observeret negativ effekt) for fertilitet, tidlig fosterudvikling og teratogenicitet i rotter blev sat til > 900 gange den humane eksponering. 
The NOAEL for fertility, early embryonic development and teratogenicity in rats was set at >900 times the human exposure.
Patienterne bør advares om risikoen for hypoglykæmi, når Trajenta anvendes i kombination med sulfonylurinstof og/eller insulin. 
However patients should be alerted to the risk of hypoglycaemia especially when combined with sulphonylurea and/or insulin.
Rifampicin: Samtidig gentagen administration af 5 mg linagliptin og rifampicin, en potent Pglykoprotein og CYP3A4-inducer, resulterede i en reduktion af linagliptin steady state -AUC og Cmax på henholdvis 39,6 % og 43,8 % og en ca. 30 % lavere DPP-4-hæmning ved trough. 
Rifampicin: multiple co-administration of 5 mg linagliptin with rifampicin, a potent inductor of P-glycoprotein and CYP3A4, resulted in a 39.6% and 43.8% decreased linagliptin steady-state AUC and Cmax, respectively, and about 30% decreased DPP-4 inhibition at trough.
Linagliptins farmakokinetik er udførligt undersøgt hos raske frivillige og hos type 2-diabetes patienter. 
The pharmacokinetics of linagliptin has been extensively characterised in healthy subjects and patients with type 2 diabetes.
Bivirkninger opstillet i tabellen nedenfor er klassificeret efter systemorganklasser og foretrukken term i henhold til MedDRA, og indberettet for patienter i dobbeltblindede studier behandlet med 5 mg linagliptin som monoterapi eller kombinationsbehandling (se tabel 1). 
Adverse reactions classified by system organ class and MedDRA preferred terms reported in patients who received 5 mg linagliptin in double-blind studies as monotherapy or as add-on therapy are presented in the table below (see table 1).
Linagliptin bør ikke anvendes under graviditeten. 
The use of linagliptin has not been studied in pregnant women.
Dosisjustering er ikke nødvendig på baggrund af køn. 
No dosage adjustment is necessary based on gender.
Ritonavir: Samtidig administration af en oral dosis af 5 mg linagliptin og multiple orale doser af 200 mg ritonavir, en potent inhibitor af P-glykoprotein og CYP3A4, gav en hhv. to- og trefoldig stigning i AUC og Cmax. 
Ritonavir: 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.
Hvis du har vedvarende, svære mavesmerter, kan det være symptomer på akut pankreatitis, og du skal kontakte din læge. 
If you have symptoms of acute pancreatitis, like persistent, severe stomach ache (abdominal pain), you should consult your doctor.
Linagliptin medførte desuden signifikant reduktion i faste-plasma-glucose (FPG), og en større andel af patienterne nåede det terapeutiske mål på HbA1c < 7,0 % sammenlignet med placebo. 
Linagliptin also provided significant improvements in fasting plasma glucose (FPG), and a greater proportion of patients achieved a target HbA1c of < 7.0%, compared to placebo.
I et åbent flerdosisstudie blev farmakokinetikken af linagliptin (5 mg dosis) undersøgt hos patienter med varierende grader af kronisk nedsat nyrefunktion og sammenlignet med raske frivillige. 
A multiple-dose, open-label study was conducted to evaluate the pharmacokinetics of linagliptin (5 mg dose) in patients with varying degrees of chronic renal insufficiency compared to normal healthy control subjects.
Linagliptin som tillægsbehandling til ældre (> 70 år) med type 2-diabetes I et dobbeltblindet 24-ugers studie blev virkningen og sikkerheden af linagliptin 5 mg evalueret hos ældre (> 70 år) med type 2-diabetes. 
Linagliptin as add-on therapy in elderly (age ≥ 70 years) with type 2 diabetes The efficacy and safety of linagliptin in elderly (age ≥ 70years) with type 2 diabetes was evaluated in a double-blind study of 24 weeks duration.
Linagliptin som tillæg til metformin og et sulfonylurinstof I et 24-ugers placebokontrolleret studie blev virkningen og sikkerheden af linagliptin 5 mg undersøgt hos patienter, der ikke var tilstrækkeligt behandlet med en kombination af metformin og et sulfonylurinstof. 
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.
Sulfonylurinstoffer: Samtidig administration af en enkelt oral dosis på 1,75 mg glibenclamid (glyburid) og daglige doser på 5 mg linagliptin medførte en klinisk irrelevant reduktion på 14 % af både AUC og Cmax for glibenclamid. 
Sulphonylureas: 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.
Perforerede alu/alu-enkeltdosisblistere i æsker indeholdende 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 og 120 x 1 filmovertrukne tabletter. 
Perforated alu/alu unit dose blisters in cartons containing 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.
EU/1/11/707/001 10 x 1 tabletter EU/1/11/707/002 14 x 1 tabletter EU/1/11/707/003 28 x 1 tabletter EU/1/11/707/004 30 x 1 tabletter EU/1/11/707/005 56 x 1 tabletter EU/1/11/707/006 60 x 1 tabletter EU/1/11/707/007 84 x 1 tabletter EU/1/11/707/008 90 x 1 tabletter EU/1/11/707/009 98 x 1 tabletter EU/1/11/707/010 100 x 1 tabletter EU/1/11/707/011 120 x 1 tabletter 
EU/1/11/707/001 10 x 1 tablets EU/1/11/707/002 14 x 1 tablets EU/1/11/707/003 28 x 1 tablets EU/1/11/707/004 30 x 1 tablets EU/1/11/707/005 56 x 1 tablets EU/1/11/707/006 60 x 1 tablets EU/1/11/707/007 84 x 1 tablets EU/1/11/707/008 90 x 1 tablets EU/1/11/707/009 98 x 1 tablets EU/1/11/707/010 100 x 1 tablets EU/1/11/707/011 120 x 1 tablets
• Carbamazepin, phenobarbital eller phenytoin, som er medicin, der bruges til at kontrollere krampeanfald eller mod kroniske smerter 
• Carbamazepine, phenobarbital or phenytoin.
Metformin: Samtidig, gentagen administration af daglige doser på 10 mg linagliptin sammen med 850 mg metformin, et OCT-substrat, havde ingen relevant indvirkning på metformins farmakokinetik hos raske frivillige. 
Metformin: co-administration of multiple daily doses of 10 mg linagliptin with 850 mg metformin, an OCT substrate, had no relevant effect on the pharmacokinetics of metformin in healthy volunteers.
Der var ingen betydende ændringer i plasma-lipidniveauer. 
Effects on plasma lipids were negligible.
Digoxin: Samtidig gentagen administration af 5 mg linagliptin og 0,25 mg digoxin dagligt havde ingen indvirkning på digoxins farmakokinetik hos raske frivillige. 
Digoxin: 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 volunteers.
I en puljet analyse af de placebokontrollerede studier var den overordnede bivirkningsfrekvens i gruppen, der fik placebo, sammenlignelig med bivirkningsfrekvensen i gruppen, der fik linagliptin 5 mg (63,4 % mod 59,1 %). 
In the pooled analysis of the placebo-controlled trials, the overall incidence of adverse events in patients treated with placebo was similar to linagliptin 5 mg (63.4% versus 59.1%).
Behandling med linagliptin 5 mg én gang dagligt medførte en signifikant reduktion i HbA1c (ændring på -0,69 % sammenlignet med placebo) hos patienter med et baselineHbA1c på ca. 8 %. 
Treatment with once daily linagliptin at 5 mg provided a significant improvement in HbA1c (-0.69% change compared to placebo), in patients with baseline HbA1c of approximately 8%.
Trajenta 5 mg filmovertrukne tabletter linagliptin 
Trajenta 5 mg film-coated tablets Linagliptin
Filmovertrukken tablet 
Film-coated tablet (tablet).
EU/1/11/707/001 (10 x 1 tabletter) EU/1/11/707/002 (14 x 1 tabletter) EU/1/11/707/003 (28 x 1 tabletter) EU/1/11/707/004 (30 x 1 tabletter) EU/1/11/707/005 (56 x 1 tabletter) EU/1/11/707/006 (60 x 1 tabletter) EU/1/11/707/007 (84 x 1 tabletter) EU/1/11/707/008 (90 x 1 tabletter) EU/1/11/707/009 (98 x 1 tabletter) EU/1/11/707/010 (100 x 1 tabletter) EU/1/11/707/011 (120 x 1 tabletter) 
EU/1/11/707/006 (60 x 1 tablets) EU/1/11/707/007 (84 x 1 tablets) EU/1/11/707/008 (90 x 1 tablets) EU/1/11/707/009 (98 x 1 tablets) EU/1/11/707/010 (100 x 1 tablets) EU/1/11/707/011 (120 x 1 tablets)
Linagliptin inducerer ikke CYPisozymer. 
It is not an inducer of CYP isozymes.
Andelen af patienter, der seponerede behandlingen som følge af bivirkninger, var højere i placebogruppen end i linagliptin 5 mg gruppen (4,3 % mod 3,4 %). 
Discontinuation of therapy due to adverse events was higher in patients who received placebo as compared to linagliptin 5 mg (4.3% versus 3.4%).
Sådan skal du tage Trajenta 
How to take Trajenta
Desuden blev patienter med type 2-diabetes og svært nedsat nyrefunktion (< 30 ml/min.) 
In addition patients with T2DM and severe renal impairment (<30 ml/min) were compared to T2DM patients with normal renal function.
Lægen vil beslutte, om enten amning eller behandling med Trajenta skal ophøre. 
A decision must be made by your doctor whether to discontinue breast-feeding or to discontinue/abstain from Trajenta therapy.
Den observerede incidens af hypoglykæmi hos patienter behandlet med linagliptin, svarede til incidensen for placebo. 
The observed incidence of hypoglycaemia in patients treated with linagliptin was similar to placebo.
Metformin: Samtidig, gentagen administration af 850 mg metformin tre gange dagligt og 10 mg linagliptin én gang dagligt gav ikke klinisk relevante ændringer i linagliptins farmakokinetik hos raske frivillige. 
Metformin: co-administration of multiple three times daily doses of 850 mg metformin with 10 mg linagliptin once daily did not clinical meaningfully alter the pharmacokinetics of linagliptin in healthy volunteers.
I kliniske studier, som beskrevet nedenfor, havde linagliptin ingen klinisk relevant indvirkning på farmakokinetikken af metformin, glyburid, simvastatin, warfarin, digoxin eller orale kontraceptiva. 
In clinical studies, as described below, linagliptin had no clinically relevant effect on the pharmacokinetics of metformin, glyburide, simvastatin, warfarin, digoxin or oral contraceptives providing in vivo evidence of a low propensity for causing medicinal product interactions with substrates of CYP3A4, CYP2C9, CYP2C8, P-glycoprotein, and organic cationic transporter (OCT).
Linagliptin viste sig desuden at medføre signifikante forbedringer i faste-plasma-glucose (FPG) sammenlignet med placebo. 
Linagliptin also showed significant improvements in fasting plasma glucose (FPG) compared to placebo.
På grund af den koncentrationsafhængige binding af linagliptin til DPP-4 var linagliptins farmakokinetik ikke lineær vurderet på baggrund af total AUC. 
Due to the concentration dependent binding of linagliptin to DPP-4, the pharmacokinetics of linagliptin based on total exposure is not linear; indeed total plasma AUC of linagliptin increased in a less than dose-proportional manner while unbound AUC increases in a roughly dose-proportional manner.
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 5 mg linagliptin. 
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 5 mg of linagliptin.
I de placebokontrollerede studier forekom bivirkningen hypoglykæmi hos 4,9 % af patienterne i behandling med linagliptin. 
In the placebo-controlled studies 4.9% of patients experienced “hypoglycaemia” as an adverse reaction under linagliptin.
Hos ikke-diabetiske patienter med let, moderat og svært nedsat leverfunktion (i henhold til ChildPugh-klassifikationen), var den gennemsnitlige AUC og Cmax sammenlignelig med raske, matchende frivillige efter indgivelse af gentagne doser af linagliptin 5 mg. Dosisjustering er ikke nødvendig hos diabetespatienter med let, moderat eller svært nedsat leverfunktion. 
In non-diabetic patients with mild moderate and severe hepatic insufficiency (according to the ChildPugh classification), mean AUC and Cmax of linagliptin were similar to healthy matched controls following administration of multiple 5 mg doses of linagliptin.
Ved symptomer på for lavt blodsukker (hypoglykæmi): Rysten, svedeture, angst, sløret syn, prikkende fornemmelse på læberne, bleghed, humørsvingninger eller forvirring, skal du stoppe med at tage Trajenta og straks kontakte en læge. 
Some symptoms need immediate medical attention You should stop taking Trajenta and see your doctor immediately if you experience the following symptoms of low blood sugar: trembling, sweating, anxiety, blurred vision, tingling lips, paleness, mood change or confusion (hypoglycaemia).
Kreatinin-clearance blev bestemt ud fra 24 timers urinopsamling eller ud fra serumkreatinin under anvendelse af Cockcroft-Gault-formlen: CrCl = (140alder) x vægt/72 x serumkreatinin [x 0,85 for kvinder], hvor alder er udtrykt i år, vægt i kg og serumkreatinin i mg/dl. Ved steady state var eksponeringen til linagliptin sammenlignelig hos patienter med let nedsat nyrefunktion og raske frivillige. 
CrCl = (140 - age) x weight/72 x serum creatinine [x 0.85 for females], where age is in years, weight in kg, and serum creatinine is in mg/dl.
Efter gentagen oral administration af linagliptin 5 mg var den effektive halveringstid for linagliptin ca. 12 timer ved steady state. 
The effective half-life for accumulation of linagliptin, as determined from oral administration of multiple doses of 5 mg linagliptin, is approximately 12 hours.
- Lægen har ordineret Trajenta til dig personligt. 
- This medicine has been prescribed for you only.
LÆGEMIDLETS NAVN Trajenta 5 mg filmovertrukne tabletter 
NAME OF THE MEDICINAL PRODUCT Trajenta 5 mg film-coated tablets
Mave-tarm-kanalen Pankreatitis sjælden 
Gastrointestinal disorders Pancreatitis rare #
Studiet omfattede patienter med nedsat nyrefunktion, der ud fra kreatinin-clearance var klassificeret som let (50 til < 80 ml/min. 
The study included patients with renal insufficiency classified on the basis of creatinine clearance as mild (50 to <80 ml/min), moderate (30 to <50 ml/min), and severe (<30 ml/min), as well as patients with ESRD on hemodialysis.
* Baseret på post-marketing-erfaringer ** Baseret på lipase-stigninger på > 3 x den øvre normalgrænse set i kliniske forsøg 
* Based on post-marketing experience ** Based on lipase elevations >3xULN observed in clinical trials Based on Linagliptin cardiovascular and renal safety study (CARMELINA), see also below Adverse reaction observed in combination with metformin plus sulphonylurea
Dosisjustering af linagliptin er ikke nødvendig hos patienter med nedsat nyrefunktion, uanset sværhedsgrad. 
Therefore, no dosage adjustment of linagliptin is necessary in patients with any degree of renal insufficiency.
Udslæt* 
Rash*
Linagliptin som monoterapi til patienter, hvor metforminbehandling er uegnet I et 24-ugers dobbeltblindet placebokontrolleret studie blev effekt og sikkerhed af linagliptin, som monoterapi, undersøgt. 
Linagliptin as monotherapy in patients ineligible for metformin The efficacy and safety of linagliptin monotherapy was evaluated in a double-blind placebo-controlled study of 24 weeks duration.
Linagliptin som tillæg til metformin plus empagliflozin Hos patienter, der ikke var tilstrækkeligt reguleret med metformin og empagliflozin (10 mg (n = 247) eller 25 mg (n = 217)), medførte 24 ugers behandling med linagliptin 5 mg som tillæg, justerede gennemsnitlige fald i HbA1c i forhold til baseline på hhv. -0,53 % (signifikant forskel ift. 
Linagliptin as add-on to a combination of metformin and empagliflozin therapy In patients inadequately controlled with metformin and empagliflozin (10 mg (n=247) or 25 mg (n=217)), 24-weeks treatment with add-on therapy of linagliptin 5 mg provided adjusted mean HbA1c reductions from baseline by -0.53% (significant difference to add-on placebo -0.32% (95% CI -0.52, -0.13) and -0.58% (significant difference to add-on placebo -0.47% (95% CI -0.66; -0.28), respectively.
Hypoglykæmi var hyppigere, når linagliptin blev givet i tillæg til et sulfonylurinstof (med metformin som basisbehandling) sammenlignet med placebo (se pkt. 
When linagliptin was added to a sulphonylurea (on a background of metformin), the incidence of hypoglycaemia was increased over that of placebo (see section 4.8).
Hvis du tager medicin, der indeholder nedenstående aktive stoffer, er det særligt vigtigt, at du taler med lægen: 
In particular, you should tell your doctor if you are using medicines containing any of the following active substances:
LÆGEMIDLETS NAVN Trajenta 5 mg filmovertrukne tabletter linagliptin 
NAME OF THE MEDICINAL PRODUCT Trajenta 5 mg film-coated tablets linagliptin
Linagliptin som tillægsbehandling til patienter med svært nedsat nyrefunktion, 12 ugers placebokontrollerede data (med uændret baggrundsbehandling) og 40 ugers placebokontrolleret forlængelse (justerbar baggrundsbehandling). 
Linagliptin as add-on therapy in patients with severe renal impairment, 12 week placebo-controlled data (stable background) and 40 week placebo-controlled extension (adjustable background) The efficacy and safety of linagliptin was also evaluated in type 2 diabetes patients with severe renal impairment in a double-blind study versus placebo for 12 weeks duration, during which background glycaemic therapies were kept stable.
Udseende og pakningsstørrelser 
What Trajenta looks like and contents of the pack
Antal patienter Primært sammensat kardiovaskulært (kardiovaskulær mortalitet, ikkedødeligt MI, ikkedødelig apopleksi) Sekundært sammensat renalt (nyredød, ESRD, 40 % vedvarende reduktion i eGFR) Mortalitet uanset årsag 
Secondary renal composite (renal death, ESRD, 40% sustained decrease in eGFR)
I et 18-ugers dobbeltblindet placebokontrolleret studie blev effekt og sikkerhed af linagliptin som monoterapi desuden undersøgt hos patienter, som ikke var egnede til behandling med metformin på grund af intolerans eller kontraindikation på grund af nedsat nyrefunktion. 
The efficacy and safety of linagliptin monotherapy was also evaluated in patients for whom metformin therapy is inappropriate, due to intolerability or contraindicated due to renal impairment, in a doubleblind placebo-controlled study of 18 weeks duration.
En hovedmetabolit med en relativ eksponering på 13,3 % af linagliptin-dosis ved steady state blev påvist. 
One main metabolite with a relative exposure of 13.3% of linagliptin at steady-state was detected which was found to be pharmacologically inactive and thus does not contribute to the plasma DPP-4 inhibitory activity of linagliptin.