FrancophonIA/ELRC3.0 huggingface dataset:
English: People aged ≥70 years The efficacy and safety of lixisenatide in people aged ≥70 years with type 2 diabetes was evaluated in a double-blind, placebo-controlled study of 24 weeks duration.
Danish: Effekten og sikkerheden af lixisenatid hos personer ≥ 70 år med type 2-diabetes blev evalueret i et dobbeltblindet, placebokontrolleret studium af 24 ugers varighed.
English: Do not use this medicine after the expiry date which is stated on the pen label and on the carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pennens etiket og på kartonen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: These changes are not clinically relevant and therefore, no dose adjustment for atorvastatin is required when co-administered with lixisenatide.
Danish: Disse ændringer er ikke klinisk relevante, og derfor kræves ingen dosisjustering for atorvastatin ved samtidig administration af lixisenatid.
English: including 198 patients ≥75 years of age and 655 patients with moderate renal impairment).
Danish: randomiseret til lixisenatid, som inkluderede 198 patienter ≥75 år og 655 patienter med moderat nedsat nyrefunktion).
English: There have been few reported events of acute pancreatitis with lixisenatide although a causal relationship has not been established.
Danish: Der har været enkelte rapporter om akut pancreatitis ved brug af lixisenatid, men en kausal sammenhæng ikke er påvist.
English: Sodium acetate trihydrate Methionine
Danish: Natriumacetattrihydrat Methionin
English: Cardiac arrhythmias particularly tachycardia (0.8% vs <0.1%) and palpitations (1.5% vs 0.8%) have been reported in lixisenatide patients compared to placebo treated patients.
Danish: Kardielle arytmier, især takykardi (0,8 % vs <1 %) og palpitationer (1,5 % vs 0,8 %), er rapporteret hos lixisenatidpatienter sammenlignet med placebobehandlede patienter.
English: Based on these results, no dose adjustment for paracetamol is required but the delayed tmax observed when paracetamol is administered 1-4 hours after lixisenatide should be taken into account when a rapid onset of action is required for efficacy.
Danish: Baseret på disse resultater kræves der ingen dosisjustering for paracetamol, men den forsinkede tmax som blev observeret, når paracetamol blev administreret 1-4 timer efter lixisenatid, skal tages i betragtning, når der er behov for hurtig indsættende effekt.
English: It is unknown if Lyxumia is excreted in human milk.
Danish: Amning Det er ukendt, om Lyxumia udskilles i human mælk.
English: At the end of the main 24-week treatment period, 32.2% of the patients having a positive antibody status had an antibody concentration above the lower limit of quantification, and at the end of the entire 76-week treatment period, 44.7% of the patients had an antibody concentration above the lower limit of quantification.
Danish: I slutningen af den 24-ugers behandlingsperiode havde 32,2 % af de patienter, der havde en positiv antistofstatus, en antistofkoncentration over den nedre grænse for kvantificering, og efter hele den 76-ugers behandlingsperiode havde 44,7 % af patienterne en antistofkoncentration over den nedre grænse for kvantificering.
English: Inject only one dose each day.
Danish: Injicer kun én dosis per dag.
English: In a study in healthy volunteers, a transient rise in heart rate has been observed after administration of lixisenatide 20 mcg.
Danish: Et studium hos raske frivillige, viste en forbigående stigning i hjertefrekvens efter administration af lixisenatid 20 µg.
English: No C-cell carcinoma was observed in mice and C-cell carcinoma occurred in rats with an exposure ratio relative to exposure at human therapeutic dose of about 900-fold.
Danish: Der sås ingen C-celle-karcinomer hos mus, og C-celle-karcinomer forekom hos rotter med en eksponeringsratio relativt til eksponering ved humane terapeutiske doser på cirka 900-fold.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 01 February 2013
Danish: Dato for første markedsføringstilladelse: 1. februar 2013 Dato for seneste fornyelse:
English: Mean systolic and diastolic blood pressure reductions up to 2.1 mmHg and up to 1.5 mmHg respectively were observed in phase III placebo-controlled studies.
Danish: Gennemsnitlig reduktion af systolisk og diastolisk blodtryk på op til henholdsvis 2,1 mmHg og 1,5 mmHg observeredes i fase III placebokontrollerede studier.
English: • Allow your pen to warm at room temperature before using.
Danish: • Lad din pen nå op på stuetemperatur, før du bruger den.
English: In a 24-week open-label study, lixisenatide administered before the main meal of the day was non-inferior to lixisenatide administered before breakfast in terms of HbA1c reduction (LS mean change from baseline: -0.65% versus -0.74%).
Danish: I et 24-ugers åbent studium var lixisenatid, administreret før det daglige hovedmåltid, non-inferiørt til lixisenatid, adminstreret før morgenmaden, med hensyn til HbA1c-reduktion (middelændring fra baseline beregnet ved mindste kvadraters metode: -0,65 % versus -0,74 %).
English: Maintenance dose: a fixed maintenance dose of 20 mcg lixisenatide once daily is started on Day 15.
Danish: Vedligeholdelsesdosis: En fast vedligeholdelsesdosis på 20 µg lixisenatid én gang dagligt startes på dag 15.
English: The clinical efficacy and safety of Lyxumia were evaluated in nine randomised double-blind, placebo-controlled clinical studies including 4,508 patients with type 2 diabetes (2,869 patients randomised to lixisenatide, 47.5% men and 52.5% women, and 517 were ≥65 years of age).
Danish: Lyxumias kliniske virkning og sikkerhed blev evalueret i ni randomiserede dobbeltblindede placebokontrollerede kliniske studier, som inkluderede 4.508 patienter med type 2-diabetes (2.869 patienter randomiseret til lixisenatid, 47,5 % mænd og 52,5 % kvinder, og 517 var ≥65 år).
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for det aktive stof eller et eller flere af hjælpestofferne anført i punkt 6.1.
English: After 12-week of optimal insulin glargine titration with or without metformin, inadequately controlled patients were randomised to add single dose of lixisenatide or a single dose (QD) of insulin glulisine (both before the largest meal) or insulin glulisine administered three times a day (TID) for 26 weeks.
Danish: Efter 12-ugers titrering til optimalt insulin glargin med eller uden metformin blev de patienter, som var utilstrækkeligt kontrollerede, randomiseret til tillæg i 26 uger af en enkelt dosis lixisenatid eller en enkelt dosis insulin glulisin (begge taget før hovedmåltidet) eller insulin glulisin administreret tre gange daglig.
English: General information
Danish: Opbevaring Generel information
English: • Each Lyxumia pen contains 14 pre-set doses.
Danish: • Hver Lyxumia-pen indeholder 14 forudindstillede doser.
English: Do not freeze Lyxumia once it has been activated.
Danish: Lyxumia må ikke nedfryses, når det er aktiveret.
English: No effects on paracetamol Cmax and tmax were observed when paracetamol was administered 1 hour before lixisenatide.
Danish: Der observeredes ingen indvirkninger på Cmax og tmax, når paracetamol blev administreret 1 time før lixisenatid.
English: Ask your doctor, pharmacist or nurse which needle gauge and length is best for you.
Danish: Spørg din læge, apotekspersonalet eller sundhedspersonalet, hvilken nålestørrelse og længde, der er bedst til dig.
English: At the end of the study, 43.6% (main meal group) and 42.8% (breakfast group) of patients achieved an HbA1c less than 7%.
Danish: Ved studiets afslutning opnåede 43,6 % af patienterne (hovedmåltidsgruppen) og 42,8 % af patienterne (morgenmadsgruppen) en HbA1c på mindre end 7 %.
English: The incidence of nausea was higher in the lixisenatide group (26.1%) compared to the placebo group (6.2%) and the incidence of vomiting was higher in the lixisenatide group (10.5%) than in the placebo group (1.8%).
Danish: Forekomsten af kvalme var højere i lixisenatidgruppen (26,1 %) end i placebogruppen (6,2 %), og forekomsten af opkastning var højere i lixisenatidgruppen (10,5 %) end i placebogruppen (1,8 %).
English: Purple 20 micrograms pen activation The purple 20 micrograms Lyxumia pen must also be activated before use.
Danish: Aktivering af lilla 20 mikrogram pen Den lilla 20 mikrogram Lyxumia-pen skal også aktiveres før brug.
English: Evening (N= 255)
Danish: Aften (N= 255)
English: Harzard Ratio with 95% CI
Danish: Hazard ratio med 95 % KI
English: • Low blood sugar (hypoglycaemia (“hypo”) especially when Lyxumia is used with insulin or a sulphonylurea
Danish: • Lavt blodsukker (hypoglykæmi (”hypo”) særligt når Lyxumia tages med insulin eller et sulfonylurinstof)
English: Starting dose: dosing is initiated at 10 mcg lixisenatide once daily for 14 days.
Danish: Startdosis: Doseringen initieres ved 10 µg lixisenatid én gang dagligt i 14 dage.
English: • If you think your Lyxumia pen may be damaged, do not use it. Get a new one.
Danish: • Hvis du har mistanke om, at din Lyxumia-pen er beskadiget, må du ikke bruge den. Anskaf en ny pen.
English: Before first use Store in a refrigerator (2°C-8°C).
Danish: Før anbrud Opbevares i køleskab (2 ºC-8 ºC).
English: When used in combination with a sulphonylurea or a basal insulin, patients should be advised to take precautions to avoid hypoglycaemia while driving and using machines.
Danish: Ved brug i kombination med et sulfonylurinstof eller basalinsulin bør patienterne tilrådes at træffe foranstaltninger for at undgå hypoglykæmi ved brug af motorkøretøj og maskiner.
English: Concomitant medicinal products
Danish: Samtidig brug af andre lægemidler
English: Add-on treatment to metformin alone
Danish: Tillægsbehandling til metformin alene
English: Body weight Body weight has no clinically relevant effect on lixisenatide AUC.
Danish: Kropsvægt Kropsvægt har ingen klinisk relevant indvirkning på AUC for lixisenatid.
English: In a pharmacokinetic study in elderly non diabetic subjects, administration of lixisenatide 20 mcg resulted in a mean increase of lixisenatide AUC by 29% in the elderly population (11 subjects aged 65
Danish: I et farmakokinetisk studium i ældre ikke-diabetiske forsøgspersoner medførte administration af lixisenatid 20 µg en gennemsnitlig øgning af lixisenatid AUC på 29 % i den ældre population (11
English: Keep the injection button pressed in and slowly count to 5 in order to expel the last drops.
Danish: Hold injektionsknappen trykket ind og tæl langsomt til 5, for at fjerne de sidste dråber.
English: Pack containing 1 green pre-filled pen.
Danish: Pakning indeholdende 1 grøn, fyldt pen.
English: New pen (orange window)
Danish: (orange vindue)
English: Uncommon side effect: may affect up to 1 in 100 people • Hives (urticaria)
Danish: Ikke almindelige bivirkninger: kan forekomme hos 1 ud af 100 patienter • Nældefeber (urticaria)
English: Do not store with a needle attached.
Danish: Må ikke opbevares med en nål påsat.
English: Treatment with Lyxumia resulted in reductions in 2-hour post-prandial glucose after a test-meal statistically superior to placebo whatever the background treatment.
Danish: Behandling med Lyxumia medførte statistisk større reduktion i 2-timers postprandial glucose efter et testmåltid i forhold til placebo, uanset baggrundsbehandlingen.
English: • If you cannot follow all the instructions completely on your own, or are not able to handle the pen
Danish: • Hvis du ikke kan følge alle instruktionerne alene, eller hvis du ikke kan håndtere pennen (hvis du f.eks. har synsproblemer), skal du kun bruge pennen, hvis du får hjælp til det.
English: Do not use this Lyxumia pack.
Danish: Du må ikke bruge denne Lyxumia-pakning.
English: A further delay in tmax and a reduced Cmax of paracetamol have been predicted with the 20 mcg maintenance dose.
Danish: Yderligere forsinkelse af tmax og reduceret Cmax for paracetamol forudses for 20 µg lixisenatid vedligeholdelsesdosis.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (28 DAYS TREATMENT INITIATION PACK)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE ÆSKE (28 DAGES BEHANDLINGSOPSTARTSPAKNING)
English: Metformin as background therapy
Danish: Metformin som baggrundsbehandling
English: Do not use Lyxumia - if you are allergic to lixisenatide or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis du er allergisk over for lixisenatid eller et af de øvrige indholdsstoffer i Lyxumia (angivet i punkt 6).
English: There was no difference in the overall safety profile in patients regardless of the antibody status with the exception of an increase of the incidence of injection site reactions (4.7% in antibody positive patients compared to 2.5% in antibody-negative patients during the entire treatment period).
Danish: Der var ingen forskel i den samlede bivirkningsprofil hos patienterne, uanset antistofstatus, med undtagelse af en øget forekomst af reaktioner på injektionsstedet (4,7 % hos antistofpositive patienter sammenlignet med 2,5 % hos antistofnegative patienter under hele behandlingsperioden).
English: Pack sizes of 1, 2 or 6 pre-filled pens.
Danish: Pakningsstørrelser på 1, 2 eller 6 fyldte penne.
English: Women of childbearing potential Lyxumia is not recommended in women of childbearing potential not using contraception.
Danish: Kvinder i den fertile alder Lyxumia bør ikke anvendes til kvinder i den fertile alder, som ikke anvender kontraception.
English: • Do not freeze Lyxumia pens and do not use Lyxumia if it has been frozen.
Danish: • Lyxumia-penne må ikke nedfryses, og Lyxumia må ikke tages, hvis det har været frosset.
English: After concomitant administration of warfarin 25 mg with repeated dosing of lixisenatide 20 mcg, there were no effects on AUC or INR (International Normalised Ratio) while Cmax was reduced by 19% and tmax was delayed by 7 hours.
Danish: Efter samtidig administration af warfarin 25 mg med gentagen dosering af lixisenatid 20 µg var der ingen indvirkninger på AUC eller INR (International Normalised Ratio), mens Cmax blev reduceret med 19 % og tmax forsinkedes 7 timer.
English: Pull the needle out of your skin and remove the needle from the pen.
Danish: Tag nålen ud af huden og tag nålen af pennen.
English: Pen Date of activation
Danish: Pen Aktiveringsdato Dato for bortskaffelse
English: Lixisenatide slows gastric emptying thereby reducing the rate at which meal-derived glucose appears in the circulation.
Danish: Lixisenatid forsinker ventrikeltømningen, og reducerer dermed den hastighed, hvormed måltidsrelateret glucose forekommer i kredsløbet.
English: Secondary composite endpoints primary + HF primary + HF + Revasc 661 (21.8%) 659 (21.7%) Individual components of composites CV death
Danish: 661 (21,8 %) 659 (21,7 %) Individuelle komponenter i sammensatte endepunkter CV død
English: Once the green 10 micrograms Lyxumia pen is empty you must continue your treatment by taking your next injection when it is due, using the purple 20 microgram Lyxumia pen.
Danish: Når den grønne 10 mikrogram Lyxumia-pen er tom, skal du fortsætte din behandling ved at bruge den lilla 20 mikrogram Lyxumia-pen når det er tid til din næste injektion.
English: Body weight change from baseline in a range from -0.38 kg to -1.80 kg was also observed in lixisenatide patients receiving stable basal insulin dose, alone or in combination with metformin or a sulphonylurea.
Danish: Der blev også observeret ændring af legemsvægt fra baseline på mellem -0,38 kg og -1,80 kg hos lixisenatidpatienter, der fik stabil dosis af basalinsulin alene eller i kombination med metformin eller et sulfonylurinstof.
English: Sanofi-Aventis Deutschland GmbH Industriepark Höchst - 65926 Frankfurt am Main Germany
Danish: Sanofi-Aventis Deutschland GmbH Industriepark Höchst - 65926 Frankfurt am Main Tyskland
English: Sulphonylurea as background therapy with or without metformin
Danish: Sulfonylurinstof som baggrundsbehandling med eller uden metformin
English: No increase in mean heart rate in patients with type 2 diabetes was seen in all placebo controlled phase III studies.
Danish: Der sås ingen stigning i gennemsnitlig hjertefrekvens hos patienter med type 2-diabetes i alle placebokontrollerede fase III-studier.
English: About Your Lyxumia pen
Danish: Om din Lyxumia-pen
English: Excipients: glycerol 85%, sodium acetate trihydrate, methionine, metacresol (see leaflet for further information), hydrochloric acid and sodium hydroxide solution (for pH adjustment), water for injections.
Danish: Hjælpestoffer: glycerol 85 %, natriumacetattrihydrat, methionin, metacresol (se indlægssedlen for yderligere oplysninger), saltsyre og natriumhydroxidopløsning (til pH-justering), vand til injektionsvæsker.
English: Step D. Press and hold the injection button to inject the dose
Danish: Trin D Tryk og hold injektionsknappen inde for at injicere dosen
English: In addition, hypoglycaemia (when Lyxumia was used in combination with a sulphonylurea and/or a basal insulin) and headache occurred.
Danish: Desuden forekom der hypoglykæmi (når Lyxumia anvendtes i kombination med et sulfonylurinstof og/eller basalinsulin) samt hovedpine.
English: Efficacy and safety of Lyxumia in patients older than 70 years was addressed in a specifically dedicated placebo-controlled study (176 patients randomised to lixisenatide, including 62 patients ≥75 years of age).
Danish: Virkning og sikkerhed af Lyxumia hos patienter ældre end 70 år blev undersøgt i et specifikt målrettet placebokontrolleret studium (176 patienter randomiseret til lixisenatid, som inkluderede 62 patienter ≥75 år).
English: Sanofi-Aventis Deutschland GmbH Brüningstrasse 50, Industriepark Höchst 65926 Frankfurt am Main Germany
Danish: Sanofi-Aventis Deutschland GmbH Brüningstrasse 50, Industriepark Höchst 65926 Frankfurt am Main Tyskland
English: Injection sites
Danish: Injektionssteder
English: Anaphylactic reactions were reported in 0.2% of the lixisenatide treated patients vs. none in the placebo group.
Danish: Anafylaktiske reaktioner blev rapporteret hos 0,2 % af lixisenatidpatienterne versus ingen i placebogruppen.
English: Other important information about using the pre-filled pens There is more information on how to use the pens in the “Instructions for Use”.
Danish: Du kan finde flere oplysninger om, hvordan pennene bruges, under ”Brugsanvisning”.
English: Lyxumia is indicated for the treatment of adults with type 2 diabetes mellitus to achieve glycaemic control in combination with oral glucose-lowering medicinal products and/or basal insulin when these, together, with diet and exercise, do not provide adequate glycaemic control (see sections 4.4 and 5.1 for available data on the different combinations).
Danish: Lyxumia er indiceret til behandlingen af voksne med type 2-diabetes mellitus for at opnå glykæmisk kontrol i kombination med orale glucosesænkende lægemidler og/eller basal insulin, når disse, sammen med diæt og motion, ikke giver en tilstrækkelig glykæmisk kontrol (se pkt.
English: In a pharmacokinetic study in elderly non-diabetic subjects, administration of lixisenatide 20 mcg resulted in a mean increase of lixisenatide AUC by 29% in the elderly population (11 subjects aged 65 to 74 years and 7 subjects aged ≥75 years) compared to 18 subjects aged 18 to 45 years, likely related to reduced renal function in the older age group.
Danish: I et farmakokinetisk studium i ældre ikke-diabetiske forsøgspersoner medførte administration af lixisenatid 20 µg en gennemsnitlig øgning af lixisenatid AUC på 29 % i den ældre population (11 forsøgspersoner mellem 65 og 74 år, og 7 forsøgspersoner i alderen ≥ 75 år) sammenlignet med 18 forsøgspersoner i alderen 18 til 45 år, sandsynligvis relateret til nedsat nyrefunktion i den ældre aldersgruppe.
English: The reductions with Lyxumia ranged from 4.51 to 7.96 mmol/L (81.2 to 143.3 mg/dl) from baseline at the end of the main 24-week treatment period across all studies in which post-prandial glucose was measured; 26.2% to 46.8% of patients had a 2-hour post-prandial glucose value below 7.8 mmol/L (140.4 mg/dl).
Danish: Reduktionen med Lyxumia lå mellem 4,51 og 7,96 mmol/l (81,2 og 143,3 mg/dl) fra baseline ved afslutning af den 24-ugers behandlingsperiode på tværs af alle studier hvor postprandial glucose blev målt og 26,2 % til 46,8 % af patienterne havde en 2-timers postprandial glucose på under 7,8 mmol/l (140,4 mg/dl).
English: Injections site reactions were reported in 3.9% of the patients receiving Lyxumia while they were reported in 1.4% of patients receiving placebo during the main 24-week treatment period.
Danish: Reaktioner på injektionsstedet blev rapporteret hos 3,9 % af de patienter, der fik Lyxumia, mens de blev rapporteret hos 1,4 % af de patienter, der fik placebo under den 24-ugers behandlingsperiode.
English: Ask your doctor, pharmacist or nurse about how to inject correctly.
Danish: Spørg din læge, apotekspersonalet eller sundhedspersonalet, hvordan man injicerer korrekt.
English: Pull off the outer and inner needle caps.
Danish: Tag det ydre nålehylser og den indre nålekapsel af.
English: Administration of the oral contraceptive 1 hour or 4 hours after lixisenatide did not affect AUC and t1/2 of ethinylestradiol and levonorgestrel, whereas Cmax of ethinylestradiol was decreased by 52% and 39% respectively and Cmax of levonorgestrel was decreased by 46% and 20%, respectively and median tmax was delayed by 1 to 3 hours.
Danish: Administration af det orale kontraceptiva 1 time eller 4 timer efter lixisenatid påvirkede ikke AUC og t1/2 for ethinylestradiol og levonorgestrel, mens Cmax for ethinylestradiol sænkedes med henholdsvis 52 % og 39 %, og Cmax for levonorgestrel sænkedes med henholdsvis 46 % og 20 %, og median tmax blev forsinket med 1 til 3 timer.
English: If you stop using Lyxumia
Danish: Hvis du holder op med at tage Lyxumia
English: Overall, the incidence of severe symptomatic hypoglycaemia was uncommon (0.4% in lixisenatide patients and 0.2% in placebo patients) during the entire treatment period of the Phase III placebo-controlled studies.
Danish: Alt i alt var forekomsten af svær symptomatisk hypoglykæmi ikke almindelig (0,4 % hos lixisenatidpatienter og 0,2 % hos placebopatienter) under hele behandlingsperioden i de placebokontrollerede fase-III studier.
English: Check that the activation window is orange.
Danish: Kontroller, at aktiveringsvinduet er orange.
English: The incidence of nausea was 24.5% in the lixisenatide group compared to 35.1% in the exenatide twice daily group and the incidence of symptomatic hypoglycaemia with lixisenatide was 2.5% during the 24-week main treatment period compared to 7.9% in the exenatide group.
Danish: Forekomsten af kvalme var 24,5 % i lixisenatidgruppen sammenlignet med 35,1 % i exenatid to gange dagligt-gruppen, og forekomsten af symptomatisk hypoglykæmi med lixisenatid var 2,5 % i den 24ugers behandlingsperiode sammenlignet med 7,9 % i exenatidgruppen.
English: The rate of symptomatic hypoglycaemic events was lower with lixisenatide (36%) compared to insulin glulisine QD and TID (47% and 52%, respectively).
Danish: Antal tilfælde af symptomatisk hypoglykæmi var lavere med lixisenatid (36 %) sammenlignet med insulin glulisin administreret en gang daglig og tre gange daglig (henholdsvis 47 %
English: Step E. Remove and throw away the needle after each injection
Danish: Trin E Fjern og kasser nålen efter hver injektion
English: Where to inject
Danish: Hvor det skal injiceres
English: Do not use this Lyxumia Treatment Initiation pack.
Danish: Du må ikke bruge denne Lyxumia behandlingsopstartspakning.
English: Keep the cap on the pen in order to protect from light.
Danish: Behold hætten på pennen for at beskytte mod lys.
English: Morning (N= 255)
Danish: Morgen (N= 255)
English: Lyxumia should not be used during pregnancy.
Danish: Lyxumia må ikke anvendes under graviditeten.
English: The reductions in fasting plasma glucose obtained with Lyxumia treatment ranged from 0.42 mmol/L to 1.19 mmol/L (7.6 to 21.4 mg/dl) from baseline at the end of the main 24-week treatment period in placebo-controlled studies.
Danish: Reduktionen i fasteplasmaglucose opnået med Lyxumia-behandling lå mellem 0,42 mmol/l og 1,19 mmol/l (7,6 og 21,4 mg/dl) fra baseline ved afslutning af den 24-ugers behandlingsperiode i placebokontrollerede studier.