natgillin/translations-raw huggingface dataset:
Det er ikke nødvendigt at ændre doseringen af de andre lægemidler, som TESAVEL indtages sammen med, undtagen når TESAVEL tages sammen med et sulfonylurinstof.
There is no need to change the doses of the other medicines TESAVEL is taken with, except when TESAVEL is taken with a sulphonylurea.
I sådanne tilfælde skal doseringen af sulfonylurinstoffet nedsættes for at mindske risikoen for hypoglykæmi (lave blodsukkerniveauer).
In such cases, the dose of the sulphonylurea may be lowered to reduce the risk of hypoglycaemia (low blood sugar levels).
TESAVEL anbefales ikke til patienter med moderat eller svær nyresygdom eller til patienter under 18 år.
TESAVEL is not recommended for use in patients who have moderate or severe problems with their kidneys, or in patients aged less than 18 years.
Hvordan virker TESAVEL?
How does TESAVEL work?
Det aktive stof i TESAVEL,
The active substance in TESAVEL, sitagliptin, is a dipeptidyl peptidase 4 (DPP-4) inhibitor.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Sitagliptin also reduces the amount of sugar made by the liver, by 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged sitagliptin, er en dipeptidylpeptidase4- hæmmer (DPP- 4- hæmmer).
Reproduction is authorised provided the source is acknowledged increasing insulin levels and decreasing the levels of the hormone glucagon.
Sitagliptin øger blodets indhold af incretinhormoner.
Together, these processes reduce blood glucose levels and help to control type 2 diabetes.
Hvordan blev TESAVEL undersøgt?
How has TESAVEL been studied?
Virkningerne af TESAVEL blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
The effects of TESAVEL were first tested in experimental models before being studied in humans.
TESAVEL blev undersøgt i fem hovedundersøgelser, der varede i op til et år, og omfattede næsten 4 000 patienter med type 2- sukkersyge, hvis blodsukkerniveauer ikke kunne kontrolleres tilstrækkeligt.
TESAVEL was studied in five main studies lasting up to a year, involving almost 4,000 patients with type 2 diabetes whose blood sugar levels were not adequately controlled.
I fire af undersøgelserne sammenlignedes TESAVEL med placebo (virkningsløs behandling), når det enten blev taget alene (to undersøgelser med 1 262 patienter) eller som et supplement til metformin (hos 702 patienter) eller til PPAR- gammaagonisten pioglitazon (hos 353 patienter).
Four of the studies compared TESAVEL to placebo (a dummy treatment), either taken alone (two studies involving 1,262 patients), or as an add-on to metformin (in 702 patients) or to the PPAR gamma agonist pioglitazone (in 353 patients).
I den femte undersøgelse blev TESAVEL sammenlignet med glipizid (et sulfonylurinstof) som tillægsbehandling til metformin hos 1 172 patienter.
The fifth study compared TESAVEL to glipizide (a sulphonylurea), as an add-on to metformin in 1,172 patients.
En yderligere undersøgelse sammenlignede TESAVEL med placebo anvendt som tillægsbehandling til glimepirid (et andet sulfonylurinstof) sammen med eller uden metformin hos 441 patienter.
An additional study compared TESAVEL to placebo, when used as an add-on to glimepiride (another sulphonylurea), with or without metformin, in 441 patients.
HbA1c giver en indikation af, hvor godt blodglykosen reguleres.
In all studies, the main measure of effectiveness was the change in the level of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
Hvilken fordel viser undersøgelserne, at der er ved TESAVEL?
What benefit has TESAVEL shown during the studies?
TESAVEL var mere effektivt end placebo, når det blev anvendt alene eller i kombination med andre lægemidler mod sukkersyge.
TESAVEL was more effective than placebo when it was taken alone or in combination with other antidiabetes medicines.
Når TESAVEL blev kombineret med metformin og givet i daglige doser på 100 mg, var HbA1c - niveauerne efter 24 uger reduceret med 0, 70% (fra 7, 96 til 7, 26%) sammenlignet med et fald på 0, 08% hos de patienter, der fik tilføjet placebo.
In combination with metformin, a daily dose of 100 mg TESAVEL reduced HbA1c by 0.70% (from 7.96 to 7.26%) after 24 weeks, compared to a fall of 0.08% in the patients adding placebo.
Dette skal sammenholdes med et fald på 0, 18% hos patienter, der fik placebo som tillægsbehandling.
In combination with pioglitazone, 100 mg TESAVEL reduced HbA1c levels by 0.88% after 24 weeks, compared to 0.18% in the patients adding placebo.
I den undersøgelse, hvor TESAVEL blev sammenlignet med glipizid som tillægsbehandling til metformin, var glipizid i begyndelsen mere effektivt end TESAVEL til at mindske indholdet af HbA1c.
In the study comparing TESAVEL and glipizide as an add-on to metformin, glipizide was initially more effective than TESAVEL in reducing HbA1c levels.
De to lægemidler havde dog nogenlunde samme effekt hos patienter, der fortsatte med at tage TESAVEL eller glipizid, efter et års behandling.
However, in patients continuing to take TESAVEL or glipizide, the two medicines had similar levels of effectiveness after a year of treatment.
TESAVEL var også mere effektiv end placebo, når det blev brugt som supplement til glimepirid (sammen med eller uden metformin).
TESAVEL was also more effective than placebo when it was added to glimepiride (with and without metformin).
Dette sænkede HbA1c- niveauerne med 0, 30% efter 24 uger hos patienter, der fik TESAVEL og glimepirid og med 0, 60% hos patienter, der også tog metformin i tillæg til TESAVEL og glimepirid.
This reduced HbA1c levels after 24 weeks by 0.30% in patients receiving TESAVEL and glimepiride, and by 0.60% in the patients who were also taking metformin in addition to TESAVEL and glimepiride.
Hvilken risiko er der forbundet med TESAVEL?
What is the risk associated with TESAVEL?
Den hyppigste bivirkning ved TESAVEL, når det tages sammen med andre lægemidler, er hypoglykæmi.
The most common side effect when taking TESAVEL with other medicines is hypoglycaemia.
Dette optræder hos flere end 1 ud af 10 patienter, når TESAVEL tages sammen med et sulfonylurinstof (sammen med eller uden metformin) og mellem 1 og 10 ud af 100 patienter, når TESAVEL tages sammen med en PPAR- gammaagonist.
This is seen in more than 1 patient in 10 when TESAVEL is taken with a sulphonylurea (with or without metformin) and in between 1 and 10 patients in 100 when TESAVEL is taken with a PPAR gamma agonist.
Når TESAVEL tages sammen med metformin alene er den hyppigste bivikning (som kunne observeres hos mellem 1 og 10 patienter ud af 100) kvalme.
When TESAVEL is taken with metformin only, the most common side effect (seen in between 1 and 10 patients in 100) is nausea (feeling sick).
Den fuldstændige liste over de indberettede bivirkninger for TESAVEL fremgår af indlægssedlen.
For the full list of all side effects reported with TESAVEL, see the Package Leaflet.
TESAVEL bør ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for sitagliptin eller andre af indholdsstofferne.
TESAVEL should not be used in people who may be hypersensitive (allergic) to sitagliptin or any of the other ingredients.
Hvorfor blev TESAVEL godkendt?
Why has TESAVEL been approved?
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved TESAVEL opvejer risiciene ved behandling af patienter med type 2- sukkersyge til forbedring af den glykæmiske regulering i kombination med metformin og/ eller et sulfonylurinstof eller en PPAR- gammaagonist, når der ved diæt og motion samt de pågældende lægemidler ikke opnås tilfredsstillende glykæmisk regulering.
The Committee for Medicinal Products for Human Use (CHMP) decided that TESAVEL’ s benefits are greater than its risks for the treatment of patients with type 2 diabetes mellitus to improve glycaemic control in combination with metformin and/ or a sulphonylurea, or a PPAR gamma agonist, when diet and exercise plus the other medicines do not provide adequate glycaemic control.
Udvalget anbefalede udstedelse af markedsføringstilladelse for TESAVEL.
The Committee recommended that TESAVEL be given marketing authorisation.
Andre oplysninger om TESAVEL:
Other information about TESAVEL:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for TESAVEL til Merck Sharp & Dohme Ltd den 10. januar 2008.
The European Commission granted a marketing authorisation valid throughout the European Union for TESAVEL to Merck Sharp & Dohme Ltd. on 10 January 2008.
Den fuldstændige EPAR for TESAVEL findes her.
The full EPAR for TESAVEL can be found here.
EMEA' s procedurenr.
EMEA Procedure number
Filmovertrukken tablet Filmovertrukken tablet Filmovertrukken tablet Filmovertrukken tablet Filmovertrukken tablet Filmovertrukken tablet
Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu) Perforeret enkeltdosisblister (PVC/ PE/ PVDC/ alu)
Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu) Perforated unit dose blister (PVC/ PE/ PVDC/ alu)
TESAVEL er indiceret:
For patients with type 2 diabetes mellitus, TESAVEL is indicated:
Til patienter med type 2- diabetes mellitus, hvor anvendelse af en PPAR - agonist (dvs. glitazoner) er hensigtsmæssig, er TESAVEL indiceret:
For patients with type 2 diabetes mellitus in whom use of a PPARγ agonist (i. e. a thiazolidinedione) is appropriate, TESAVEL is indicated:
• i kombination med PPAR - agonisten, i de tilfælde hvor diæt og motion plus PPAR - agonisten alene ikke giver tilstrækkelig glykæmisk kontrol.
• in combination with the PPARγ agonist when diet and exercise plus the PPARγ agonist alone do not provide adequate glycaemic control.
Dosis for TESAVEL er 100 mg én gang dagligt.
The dose of TESAVEL is 100 mg once daily.
Når TESAVEL anvendes i kombination med et sulfonylurinstof, kan en lavere dosis af sulfonylurinstoffet overvejes for at reducere risikoen for hypoglykæmi (se pkt.
When TESAVEL is used in combination with a sulphonylurea, a lower dose of the sulphonylurea may be considered to reduce the risk of hypoglycaemia.
2 Patienter med nyreinsufficiens Til patienter med mild nyreinsufficiens (kreatinin- clearance [CrCl] ≥50 ml/ min), er dosisjustering for TESAVEL ikke nødvendig.
2 Patients with renal insufficiency For patients with mild renal insufficiency (creatinine clearance [CrCl] ≥ 50 ml/ min), no dosage adjustment for TESAVEL is required.
Erfaring fra kliniske undersøgelser af TESAVEL til patienter med moderat eller svær nyreinsufficiens er begrænset.
Clinical study experience with TESAVEL in patients with moderate or severe renal insufficiency is limited.
Derfor bør TESAVEL ikke anvendes til denne patientgruppe (se afsnit 5. 2).
Therefore, use of TESAVEL is not recommended in this patient population (see section 5.2).
TESAVEL er ikke undersøgt hos patienter med svær leverinsufficiens.
TESAVEL has not been studied in patients with severe hepatic insufficiency.
Børn TESAVEL bør ikke anvendes til børn under 18 år p. g. a. manglende dokumentation for sikkerhed og virkning.
Paediatric population TESAVEL is not recommended for use in children below 18 years of age due to a lack of data on its safety and efficacy.
Generelt TESAVEL bør ikke anvendes til patienter med type 1- diabetes eller til behandling af diabetisk ketoacidose.
General TESAVEL should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
Her var hyppigheden af hypoglykæmi, der er rapporteret for de patienter, der fik sitagliptin, den samme som hos de patienter, der fik placebo.
Hypoglycaemia when used in combination with other anti-hyperglycaemic agents In clinical trials of TESAVEL as monotherapy and as part of combination therapy with agents not known to cause hypoglycaemia (i. e. metformin or pioglitazone), rates of hypoglycaemia reported with sitagliptin were similar to rates in patients taking placebo.
Anvendelsen af sitagliptin sammen med insulin er ikke undersøgt tilstrækkeligt.
The use of sitagliptin in combination with insulin has not been adequately studied.
Nyreinsufficiens Patienter med moderat til svær nyreinsufficiens bør ikke behandles med TESAVEL, da erfaringen med denne patientgruppe er begrænset (se afsnit 5. 2).
Renal insufficiency As the experience is limited, patients with moderate to severe renal insufficiency should not be treated with TESAVEL (see section 5.2).
Hypersensitivitetsreaktioner Efter markedsføring er der rapporteret om alvorlige hypersensitivitetsreaktioner hos patienter, der er blevet behandlet med TESAVEL.
Hypersensitivity Reactions Postmarketing reports of serious hypersensitivity reactions in patients treated with TESAVEL have been reported.
Disse reaktioner startede inden for de første 3 måneder efter initiering af behandling med TESAVEL, og nogle rapporter kom efter første dosis.
Onset of these reactions occurred within the first 3 months after initiation of treatment with TESAVEL, with some reports occurring after the first dose.
4. 8).
If a hypersensitivity reaction is suspected, discontinue TESAVEL, assess for other potential causes for the event, and institute alternative treatment for diabetes (see section 4.8).
Andre lægemidlers indvirkning på sitagliptin De kliniske data, der er beskrevet nedenfor tyder på, at risikoen er lav for interaktioner af klinisk betydning mellem lægemidler, der administreres samtidigt.
Effects of other medicinal products on sitagliptin Clinical data described below suggest that the risk for clinically meaningful interactions by co- administered medicinal products is low.
Metformin:
3 Metformin:
Efter administration af 0, 25 mg digoxin samtidig med 100 mg TESAVEL dagligt i 10 dage, øgedes plasma AUC for digoxin gennemsnitligt med 11% og plasma Cmax med gennemsnitligt 18%.
Following administration of 0.25 mg digoxin concomitantly with 100 mg of TESAVEL daily for 10 days, the plasma AUC of digoxin was increased on average by 11%, and the plasma Cmax on average by 18%.
Graviditet Der er ikke tilstrækkelige data for anvendelse af TESAVEL til gravide kvinder.
Pregnancy There are no adequate data from the use of TESAVEL in pregnant women.
Dyreundersøgelser har vist reproduktionstoksicitet ved høje doser (se afsnit 5. 3).
Studies in animals have shown reproductive toxicity at high doses (see section 5.3).
I 9 store kliniske undersøgelser af op til 2 års varighed er mere end 2. 700 patienter blevet behandlet med TESAVEL 100 mg dagligt, alene eller i kombination med metformin, et sulfonylurinstof (med eller uden metformin) eller en PPARγ- agonist.
In 9 large clinical trials of up to 2 years in duration, over 2700 patients have received treatment with TESAVEL 100 mg per day alone or in combination with metformin, a sulphonylurea (with or without metformin) or a PPARγ agent.
Der blev ikke oftere (> 0, 2% og difference > 1 patient) rapporteret om bivirkninger hos de patienter, der blev behandlet med sitagliptin, end hos de patienter, der blev behandlet med kontrolpræparatet.
No adverse reactions considered as drug-related were reported in patients treated with sitagliptin occurring in excess (> 0.2% and difference > 1 patient) of that in patients treated with control.
Nedenfor (i tabel 1) nævnes de formodede bivirkninger, inddelt i systemorganklasse og frekvens, som oftere blev rapporteret (> 0, 2% og difference > 1 patient) hos de patienter, der blev behandlet med sitagliptin end hos de patienter, der fik placebo.
Adverse reactions considered as drug-related reported in patients treated with sitagliptin occurring in excess (> 0.2% and difference > 1 patient) of that in patients treated with placebo are listed below (Table 1) by system organ class and frequency.
Meget almindelig (≥1/ 10); almindelig (≥1/ 100, < 1/ 10); ikke almindelig (≥1/ 1. 000, < 1/ 100); sjælden (≥1/ 10. 000, < 1/ 1. 000); og meget sjælden (< 1/ 10. 000).
Frequencies are defined as: very common (≥ 1/ 10); common (≥ 1/ 100, < 1/ 10); uncommon (≥ 1/ 1000, < 1/ 100); rare (≥ 1/ 10000, < 1/ 1000); and very rare (< 1/ 10000).
Sitagliptin Sitagliptin
Sitagliptin with Sitagliptin with Sitagliptin with 1 2
Sitagliptin sam -
Sitagliptin with
Sitagliptin sam -
Metformin
men med met - formin og et
a Sulfonylurea
men med et PPARγ - γ
Metformin and a a PPARγ Agent Sulfonylurea3 (pioglitazone)4
sulfonylurinstof
Metabolism and nutrition disorders
lægemiddel
hypoglycaemia*
(pioglitazon) 4
Very common
Metabolisme og ernæring Hypoglykæmi *
Very common Common
Meget almindelig Meget almindelig
Nervous system disorders somnolence
Nervesystemet Somnolens
Gastrointestinal disorders
Mave- tarmkanalen Ikke alminde - Diarré lig Kvalme Flatulens Forstoppelse
diarrhea nausea flatulence constipation upper abdominal pain
Almindelig
Uncommon Common Uncommon
Øvre abdominals - merter
General disorders peripheral oedema
Ikke alminde - lig
Uncommon
* I kliniske undersøgelser af TESAVEL som monoterapi og sitagliptin som del af en kombinationsbehandling med metformin eller pioglitazon var frekvensen af hypoglykæmi, der blev rapporteret for sitagliptin, den samme som for de patienter, der fik placebo.
In clinical trials of TESAVEL as monotherapy and sitagliptin as part of combination therapy with metformin or pioglitazone, rates of hypoglycaemia reported with sitagliptin were similar to rates in patients taking placebo.
1 I denne placebo- kontrollerede 24- ugers- undersøgelse af sitagliptin 100 mg én gang dagligt i kombination med metformin var incidensen af formodede bivirkninger 9, 3% hos de patienter, der blev behandlet med sitagliptin/ metformin sammenlignet med 10, 1% hos de patienter, der fik placebo/ metformin.
1 In this placebo-controlled 24-week study of sitagliptin 100 mg once daily in combination with metformin, the incidence of adverse reactions considered as drug-related in patients treated with sitagliptin/ metformin compared to treatment with placebo/ metformin was 9.3% and 10.1%, respectively.
I en supplerende 1- års undersøgelse af sitagliptin 100 mg én gang dagligt i kombination med metformin var incidensen af formodede bivirkninger hos de patienter, der blev behandlet med sitagliptin/ metformin sammenlignet med de patienter, der fik et sulfonylurinstof/ metformin henholdsvis 14, 5% og 30, 3%.
5 In an additional 1-year study of sitagliptin 100 mg once daily in combination with metformin, the incidence of adverse reactions considered as drug-related in patients treated with sitagliptin/ metformin compared to sulphonylurea/ metformin was 14.5% and 30.3%, respectively.
4 I denne 24- ugers undersøgelse af sitagliptin 100 mg én gang dagligt i kombination med pioglitazon var incidensen af formodede bivirkninger hos de patienter, der blev behandlet med sitagliptin/ pioglitazon sammenlignet med patienterne, der blev behandlet med placebo/ pioglitazon henholdsvis 9, 1% og 9, 0%.
4 In this 24-week study of the combination of sitagliptin 100 mg once daily and pioglitazone, the incidence of adverse reactions considered as drug-related in patients treated with sitagliptin/ pioglitazone compared to patients treated with placebo/ pioglitazone was 9.1% and 9.0%, respectively.
Disse hændelser inkluderede infektion i øvre luftveje og nasopharyngitis.
In addition to the drug-related adverse experiences described above, adverse experiences reported regardless of causal relationship to medication and occurring in at least 5% and more commonly in patients treated with TESAVEL included upper respiratory tract infection and nasopharyngitis.
Yderligere hændelser, der er rapporteret uden kendt årsagssammenhæng med medicinen, og som forekom hyppigere hos de patienter, der blev behandlet med TESAVEL (uden at nå 5% niveauet, men med en incidens > 0, 5%, der er højere i TESAVEL - end i kontrolgruppen) omfatter osteoartrose og smerter i ekstremiteterne.
Additional adverse experiences reported regardless of causal relationship to medication that occurred more frequently in patients treated with TESAVEL (not reaching the 5% level, but occurring with an incidence of > 0.5% higher with TESAVEL than that in the control group) included osteoarthritis and pain in extremity.
I en 24- ugers undersøgelse af den initiale kombinationsbehandling med sitagliptin og metformin to gange dagligt (sitagliptin/ metformin 50 mg/ 500 mg eller 50 mg/ 1. 000 mg) var den totale bivirkningsincidens, som blev anset for at være lægemiddelrelateret, henholdsvis 14, 0% og 9, 7% hos 6 de patienter, der blev behandlet med kombinationen af sitagliptin og metformin sammenlignet med de patienter, der fik placebo.
In a 24-week study of initial combination therapy with sitagliptin and metformin administered twice daily (sitagliptin/ metformin 50 mg/ 500 mg or 50 mg/ 1000 mg), the overall incidence of adverse reactions considered as drug-related in patients treated with the combination of sitagliptin and metformin compared to patients treated with placebo was 14.0% and 9.7%, respectively.
Der blev ikke observeret klinisk relevante ændringer i vitale tegn eller i EKG (inklusive i QTc - intervallet) ved behandling med TESAVEL.
No clinically meaningful changes in vital signs or in ECG (including in QTc interval) were observed with TESAVEL treatment.
Efter markedsføring:
6 Post-marketing Experience:
TESAVEL tilhører en klasse af orale anti- hyperglykæmiske lægemidler, der kaldes dipeptidylpeptidase- 4- hæmmere.
TESAVEL is a member of a class of oral anti-hyperglycaemic agents called dipeptidyl peptidase 4 (DPP-4) inhibitors.
Behandling med GLP- 1 eller DPP- 4- hæmmere i dyremodeller af type 2 - diabetes har vist sig at forbedre betacellernes reaktion på glucose og at stimulere syntesen samt frigivelsen af insulin.
Treatment with GLP-1 or with DPP-4 inhibitors in animal models of type 2 diabetes has been demonstrated to improve beta cell responsiveness to glucose and stimulate insulin biosynthesis and release.
Reducerede glucagonkoncentrationer fører, sammen med højere insulinniveauer, til reduceret hepatisk glucoseproduktion, hvilket resulterer
Decreased glucagon concentrations, along with higher insulin levels, lead to reduced hepatic glucose production, resulting in a decrease in blood glucose levels.
Sitagliptin er en potent og høj- selektiv hæmmer af enzymet DPP- 4og hæmmer ikke de nært beslægtede enzymer DPP- 8 eller DPP- 9 ved terapeutiske koncentrationer.
Sitagliptin is a potent and highly selective inhibitor of the enzyme DPP-4 and does not inhibit the closely-related enzymes DPP-8 or DPP-9 at therapeutic concentrations.
Målt som klinisk relevante reduktioner i HbA1c i forhold til baseline ved study endpoint (se Tabel 2) forbedrer sitagliptin totalt set den glykæmiske kontrol, når det gives som monoterapi, i kombination med metformin (initialt eller som tillægsterapi), i kombination med sulfonylurinstof (med eller uden metformin) og i kombination med et glitazon.
7 Overall, sitagliptin improved glycaemic control when given as monotherapy, when used in combination with metformin (initial or add-on therapy), in combination with a sulphonylurea (with or without metformin), and in combination with a thiazolidinedione, as measured by clinically relevant reductions in HbA1c from baseline at study endpoint (see Table 2).
Der er udført to undersøgelser, der vurderede effekt og sikkerhed af TESAVEL- monoterapi.
Two studies were conducted to evaluate the efficacy and safety of TESAVEL monotherapy.
Sammenlignet med placebo gav behandling med sitagliptin 100 mg én gang dagligt som monoterapi signifikante forbedringer i HbA1c, i faste- plasmaglucose, (FPG) og 2- timers postprandial glucose (2 - timers PPG), når det blev sammenlignet med placebo i to undersøgelser, hvor den ene var af 18 ugers varighed og den anden af 24 ugers varighed.
Treatment with sitagliptin at 100 mg once daily as monotherapy provided significant improvements in HbA1c, fasting plasma glucose (FPG), and 2-hour post-prandial glucose (2-hour PPG), compared to placebo in two studies, one of 18- and one of 24-weeks duration.