natgillin/translations-raw huggingface dataset:
TESAVEL се използва за лечение на пациенти с диабет тип 2 за постигане на по- добър контрол на нивата на кръвната захар.
TESAVEL is used to treat patients with type 2 diabetes, to improve control of blood sugar levels.
Използва се в комбинация с диета и упражнения, заедно с едно или повече противодиабетни лекарства: • в комбинация с метформин при пациенти, при които няма задоволителен контрол с прилаган самостоятелно метформин, • в комбинация със сулфанилурея при пациенти, при които няма задоволителен контрол с прилагана самостоятелно сулфанилурея и при които метформин не е подходящ, • в комбинация със сулфанилурея и метформин, когато при двойна терапия с тези средства не се постига задоволителен контрол на диабета, • в комбинация с PPAR гама агонист, напр. тиазолидиндион при пациенти, при които няма задоволителен контрол с прилаган самостоятелно PPAR гама агонист.
It is used with diet and exercise, together with one or more antidiabetes medicines: • in combination with metformin, in patients who are not satisfactorily controlled on metformin alone; • in combination with a sulphonylurea in patients who are not satisfactorily controlled with a sulphonylurea alone and in whom metformin is not suitable; • in combination with both metformin and a sulphonylurea, when both medicines are not sufficient to give satisfactory control of the patient ’ s diabetes; • in combination with a PPAR gamma agonist, such as a thiazolidinedione, in patients who are not satisfactorily controlled on the PPAR gamma agonist alone.
Как да използвате TESAVEL?
How is TESAVEL used?
TESAVEL се приема в доза от 100 mg веднъж дневно със или без храна.
TESAVEL is taken at a dose of 100 mg once a day, with or without food.
Не е необходимо да бъдат променяни дозите на другите лекарства, с които се приема TESAVEL с изключение на случаите, когато се приема със сулфанилурея.
There is no need to change the doses of the other medicines TESAVEL is taken with, except when TESAVEL is taken with a sulphonylurea.
В такива случаи дозата сулфанилурея може да бъде намалена, за да се понижи рискът от хипогликемия (ниски нива на кръвната захар).
In such cases, the dose of the sulphonylurea may be lowered to reduce the risk of hypoglycaemia (low blood sugar levels).
TESAVEL не се препоръчва при пациенти с умерени или тежки проблеми на бъбреците или при пациенти под 18- годишна възраст.
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.
Как действа TESAVEL?
How does TESAVEL work?
Диабет тип 2 е заболяване, при която панкреасът не произвежда достатъчно инсулин за контролиране нивото на глюкоза (захарта) в кръвта или когато тялото е неспособно да използва инсулина ефективно.
Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose (sugar) in the blood or when the body is unable to use insulin effectively.
Активното вещество в TESAVEL, ситаглиптин, представлява инхибитор на дипептидил пептидаза 4 (DPP- 4).
The active substance in TESAVEL, sitagliptin, is a dipeptidyl peptidase 4 (DPP-4) inhibitor.
Действието му блокира разграждането на инкретин хормоните в тялото.
These hormones are released after a meal and stimulate the pancreas to produce insulin.
Тези хормони се освобождават след хранене и стимулират панкреаса да произвежда инсулин.
By increasing levels of incretin hormones in the blood, sitagliptin stimulates the pancreas to produce more insulin when blood sugar levels are high.
Като повишава нивата на инкретин хормоните в кръвта, ситаглиптин стимулира панкреаса да произвежда повече инсулин, когато нивата на кръвната захар са високи.
Sitagliptin also reduces the amount of sugar made by the liver, by 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Ситаглиптин не действа, когато кръвната захар е ниска.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu © European Medicines Agency, 2008.
Ситаглиптин намалява също количеството захар, произведено от черния дроб, като повишава нивата на инсулина и понижава нивата на хормона глюкагон.
Reproduction is authorised provided the source is acknowledged increasing insulin levels and decreasing the levels of the hormone glucagon.
Съвкупно тези процеси намаляват нивата на глюкозата в кръвта и подпомагат контролирането на диабет тип 2.
Together, these processes reduce blood glucose levels and help to control type 2 diabetes.
Как е проучен TESAVEL?
How has TESAVEL been studied?
Преди провеждане на проучвания при хора ефектите на TESAVEL са изследвани върху експериментални модели.
The effects of TESAVEL were first tested in experimental models before being studied in humans.
TESAVEL е проучен в пет основни проучвания с продължителност до една година с участието на почти 4000 пациенти с диабет тип 2, чиято кръвна захар не е адекватно контролирана.
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.
Четири от проучванията сравняват TESAVEL с плацебо (сляпо лечение), приеман самостоятелно (две проучвания, включващи 1262 пациенти), като допълнение към метформин (при 702 пациенти) или като допълнение към PPAR гама агониста пиоглитазон (при 353 пациенти).
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).
Петото проучване сравнява TESAVEL с глипизид (вид сулфонилурея) като допълнение към метформин при 1172 пациенти.
The fifth study compared TESAVEL to glipizide (a sulphonylurea), as an add-on to metformin in 1,172 patients.
Едно допълнително проучване сравнява TESAVEL с плацебо, когато се използва като допълнение към глимепирид (друг вид сулфонилурея) със или без метформин при 441 пациенти.
An additional study compared TESAVEL to placebo, when used as an add-on to glimepiride (another sulphonylurea), with or without metformin, in 441 patients.
Във всички проучвания основната мярка за ефективност е промяната на кръвните нива на вещество, наречено гликиран хемоглобин (HbA1c), което показва до каква степен се контролира нивото на кръвната захар.
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.
Какви ползи от TESAVEL са установени в проучванията?
What benefit has TESAVEL shown during the studies?
TESAVEL е по- ефективен от плацебо, когато се приема самостоятелно или в комбинация с други противодиабетни лекарства.
TESAVEL was more effective than placebo when it was taken alone or in combination with other antidiabetes medicines.
В комбинация с метформин дневната доза от 100 mg TESAVEL намалява HbA1c с 0, 70% (от 7, 96 на 7, 26%) след 24 седмици в сравнение с понижение от 0, 08% при пациентите, приемащи плацебо като допълнение.
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.
В комбинация с пиоглитазон доза от 100 mg TESAVEL намалява нивата на HbA1c с 0, 88% след 24 седмици в сравнение с 0, 18% при пациентите, приемащи плацебо като допълнение.
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.
В проучването, сравняващо TESAVEL с глипизид като допълнение към метформин, глипизид първоначално е по- ефикасен от TESAVEL за понижаване на нивата на 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.
След една година лечение обаче при пациентите, продължаващи да приемат TESAVEL или глипизид, двете лекарства имат сходна ефективност.
However, in patients continuing to take TESAVEL or glipizide, the two medicines had similar levels of effectiveness after a year of treatment.
TESAVEL е също по- ефективен от плацебо, когато се приема като допълнение към глимепирид (със или без метформин).
TESAVEL was also more effective than placebo when it was added to glimepiride (with and without metformin).
След 24 седмици това намалява нивата на HbA1c с 0, 30% при пациентите, приемащи TESAVEL и глимепирид, и с 0, 60% при пациентите, приемащи метформин в допълнение към TESAVEL и глимепирид.
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.
Какви са рисковете, свързани с TESAVEL?
What is the risk associated with TESAVEL?
Най- честата нежелана реакция при приема на TESAVEL с други лекарства е хипогликемия.
The most common side effect when taking TESAVEL with other medicines is hypoglycaemia.
Наблюдава се при повече от 1 на 10 пациенти, когато TESAVEL се приема със сулфонилурея (със или без метформин) и при 1 до 10 пациенти на 100, когато TESAVEL се приема с PPAR гама агонист.
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.
Когато TESAVEL се приема само с метформин, най- честата нежелана реакция (наблюдавана при 1 до 10 пациенти на 100) е гадене (позиви за повръщане).
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).
За пълния списък на всички наблюдавани при TESAVEL нежелани реакции – вижте листовката.
For the full list of all side effects reported with TESAVEL, see the Package Leaflet.
TESAVEL е противопоказен при хора, които биха могли да проявят свръхчувствителност (алергични реакции) към ситаглиптин или някоя от другите съставки.
TESAVEL should not be used in people who may be hypersensitive (allergic) to sitagliptin or any of the other ingredients.
Основания за одобряване на TESAVEL?
Why has TESAVEL been approved?
Комитетът по лекарствените продукти за хуманна употреба (CHMP) решава, че ползите от TESAVEL са по- големи от рисковете при лечение на пациенти със захарен диабет тип 2 за подобряване на гликемичния контрол
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.
Комитетът препоръчва на TESAVEL да бъде издадено разрешение за употреба.
The Committee recommended that TESAVEL be given marketing authorisation.
Допълнителна информация за TESAVEL:
Other information about TESAVEL:
Европейската комисия издава разрешение за употреба, валидно в рамките на Европейския съюз, за TESAVEL на Merck Sharp & Dohme Ltd на 10 януари 2008 г.
The European Commission granted a marketing authorisation valid throughout the European Union for TESAVEL to Merck Sharp & Dohme Ltd. on 10 January 2008.
Пълният текст на EPAR относно TESAVEL може да се намери тук.
The full EPAR for TESAVEL can be found here.
Номер на процедурата на ЕМЕА № на ЕС
EMEA Procedure number
EMEA/ H/ C/ 910/ 01
EMEA/ H/ C/ 910/ 01 EMEA/ H/ C/ 910/ 02 EMEA/ H/ C/ 910/ 03 EMEA/ H/ C/ 910/ 04 EMEA/ H/ C/ 910/ 05 EMEA/ H/ C/ 910/ 06
TESAVEL
TESAVEL TESAVEL TESAVEL TESAVEL TESAVEL TESAVEL
25 mg
25 mg 25 mg 25 mg 25 mg 25 mg 25 mg
Филмирана таблетка
Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Блистер 25 mg (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)
14
14 28 56 84 98 50x1
EMEA/ H/ C/ 910/ 07
EMEA/ H/ C/ 910/ 07 EMEA/ H/ C/ 910/ 08 EMEA/ H/ C/ 910/ 09 EMEA/ H/ C/ 910/ 10 EMEA/ H/ C/ 910/ 11 EMEA/ H/ C/ 910/ 12
50 mg
50 mg 50 mg 50 mg 50 mg 50 mg 50 mg
Блистер 50 mg (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)
EMEA/ H/ C/ 910/ 13
EMEA/ H/ C/ 910/ 13 EMEA/ H/ C/ 910/ 14 EMEA/ H/ C/ 910/ 15 EMEA/ H/ C/ 910/ 16 EMEA/ H/ C/ 910/ 17 EMEA/ H/ C/ 910/ 18
100 mg
100 mg 100 mg 100 mg 100 mg 100 mg 100 mg
Блистер 100 mg (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 25 mg
TESAVEL 25 mg film-coated tablets
(sitagliptin phosphate monohydrate),
QUALITATIVE AND QUANTITATIVE COMPOSITION
25 mg
Each tablet contains sitagliptin phosphate monohydrate, equivalent to 25 mg sitagliptin.
(sitagliptin).
For a full list of excipients, see section 6.1.
(
Film-coated tablet (tablet)
“ 221 ”
Round, pink film-coated tablet with “ 221” on one side.
2, TESAVEL
CLINICAL PARTICULARS
), TESAVEL
4.1 Therapeutic indications
:
For patients with type 2 diabetes mellitus, TESAVEL is indicated:
•
• to improve glycaemic control in combination with metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control.
PPAR!
• to improve glycaemic control in combination with a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance.
,
• to improve glycaemic control in combination with a sulphonylurea and metformin when diet and exercise plus dual therapy with these agents do not provide adequate glycaemic control.
PPAR!
For patients with type 2 diabetes mellitus in whom use of a PPARγ agonist (i. e. a thiazolidinedione) is appropriate, TESAVEL is indicated:
.
• in combination with the PPARγ agonist when diet and exercise plus the PPARγ agonist alone do not provide adequate glycaemic control.
4. 2
4.2 Posology and method of administration
TESAVEL 100 mg,
The dose of TESAVEL is 100 mg once daily.
. "
When TESAVEL is used in combination with a sulphonylurea, a lower dose of the sulphonylurea may be considered to reduce the risk of hypoglycaemia.
4. 4).
(See section 4.4.)
#
A double dose should not be taken on the same day.
TESAVEL.
TESAVEL can be taken with or without food.
[CrCl] ≥ 50 ml/ min),
2 Patients with renal insufficiency For patients with mild renal insufficiency (creatinine clearance [CrCl] ≥ 50 ml/ min), no dosage adjustment for TESAVEL is required.
%
Therefore, use of TESAVEL is not recommended in this patient population (see section 5.2).
TESAVEL
TESAVEL has not been studied in patients with severe hepatic insufficiency.
. $
Elderly No dosage adjustment is necessary based on age.
(75
Limited safety data is available in patients ≥ 75 years of age and care should be exercised.
18
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.
TESAVEL..
4.3 Contraindications
TESAVEL,
Hypersensitivity to the active substance or to any of the excipients (see section 4.4 and 4.8).
TESAVEL,
4.4 Special warnings and precautions for use
1 000 mg
General TESAVEL should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
: $
The use of sitagliptin in combination with insulin has not been adequately studied.
,
Renal insufficiency As the experience is limited, patients with moderate to severe renal insufficiency should not be treated with TESAVEL (see section 5.2).
p -
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).
100 mg TESAVEL
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.
AUC Cmax p -
3 Metformin:
CYP3A4 - ESRD (
Cyclosporine:
CYP2C8. $
The renal clearance of sitagliptin was not meaningfully altered.
.). $
The effects of potent CYP3A4 inhibitors in the setting of renal insufficiency has not been assessed in a clinical study.
In vitro OAT3.
In vitro transport studies showed that sitagliptin is a substrate for p-glycoprotein and OAT3.
OAT3
Concomitant administration of OAT3 inhibitors has not been evaluated in vivo.
,
In clinical studies, sitagliptin did not meaningfully alter the pharmacokinetics of metformin, glyburide, simvastatin, rosiglitazone, warfarin, or oral contraceptives, providing in vivo evidence of a low propensity for causing interactions with substrates of CYP3A4, CYP2C8, CYP2C9, and organic cationic transporter (OCT).
in vitro. /
Sitagliptin had a small effect on plasma digoxin concentrations, and may be a mild inhibitor of p- glycoprotein in vivo.
OAT3
Digoxin:
in vivo.
No dosage adjustment of digoxin is recommended.
In vitro
4.6 Pregnancy and lactation
,,,,
The potential risk for humans is unknown.
CYP3A4, CYP2C8, CYP2C9
Due to lack of human data, TESAVEL should not be used during pregnancy.
(
TESAVEL should not be used during breast-feeding.
)
4.7 Effects on ability to drive and use machines
(OCT).
However, when driving or operating machines, it should be taken into account that dizziness and somnolence have been reported.
in vivo.
4 4.8 Undesirable effects
: '
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.
100 mg TESAVEL
In these trials, the rate of discontinuation due to adverse experiences considered drug-related was 0.8% with 100 mg per day and 1.5% with other treatments.
10 &
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).
TESAVEL
Table 1.
((1/ 100, < 1/ 10);
Adverse Reaction
((1/ 10, 000, < 1/ 1, 000);
Frequency of adverse reaction by treatment regimen
1
Sitagliptin with Sitagliptin with Sitagliptin with 1 2
# '"+' # - # '"
Sitagliptin with
() #! (0 *
Metformin
$#% "
a Sulfonylurea
+
Metformin and a a PPARγ Agent Sulfonylurea3 (pioglitazone)4
$#
Metabolism and nutrition disorders
PPARγ
hypoglycaemia*
+ '# -
Very common
# '"+' # - # '"
Very common Common
(
Nervous system disorders somnolence
* $TESAVEL, 1
Uncommon
10, 1%.
Gastrointestinal disorders
$
diarrhea nausea flatulence constipation upper abdominal pain
(> 0, 2%
Uncommon Common Uncommon
> 1
Common
(> 0, 2%,,
Common
TESAVEL (TESAVEL,
General disorders peripheral oedema
> 0, 5%
Common
50 mg/ 1 000 mg),
Investigations blood glucose decreased *
(6, 7%),
Uncommon
(14, 0%
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.
)
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 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.
*
In addition, in monotherapy studies of up to 24 weeks in duration of sitagliptin 100 mg once daily alone compared to placebo, adverse reactions considered as drug-related reported in patients treated with sitagliptin in excess (> 0.2% and difference > 1 patient) of that in patients receiving placebo are headache, hypoglycaemia, constipation, and dizziness.
-
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.
.
The overall incidence of adverse reactions considered as drug-related in patients treated with the combination of sitagliptin and metformin was comparable to metformin alone (14.0% each) and greater than sitagliptin alone (6.7%), with the differences relative to sitagliptin alone primarily due to gastrointestinal adverse reactions.
200
This observation was seen in most but not all studies.
/ microl
No clinically meaningful changes in vital signs or in ECG (including in QTc interval) were observed with TESAVEL treatment.
Stevens- Johnson (
6 Post-marketing Experience:
4. 4).
4.9 Overdose
$, 800 mg
During controlled clinical trials in healthy subjects, single doses of up to 800 mg sitagliptin were generally well tolerated.
800 mg
Minimal increases in QTc, not considered to be clinically relevant, were observed in one study at a dose of 800 mg sitagliptin.
800 mg
There is no experience with doses above 800 mg in humans.
.
In the event of an overdose, it is reasonable to employ the usual supportive measures, e. g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring (including obtaining an electrocardiogram), and institute supportive therapy if required.
. $3 - 4
Sitagliptin is modestly dialyzable.
DPP- 4
Pharmacotherapeutic group:
, ATC
DPP-4 Inhibitor, ATC code:
TESAVEL
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.
4
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).
(DPP- 4) -
Two studies were conducted to evaluate the efficacy and safety of TESAVEL monotherapy.
100 mg
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.
HOMA- 3 (Homeostasis Model
Improvement of surrogate markers of beta cell function, including HOMA-β (Homeostasis Model Assessment-β), proinsulin to insulin ratio, and measures of beta cell responsiveness from the frequently-sampled meal tolerance test were observed.
Assessment- 3),
The number of patients with moderate to severe renal insufficiency was too low to confirm safe use of sitagliptin in this type of patients.
100 mg
Sitagliptin 100 mg once daily provided significant improvements in glycaemic parameters compared with placebo in two 24-week studies of sitagliptin as add-on therapy, one in combination with metformin and one in combination with pioglitazone.
(100 mg
A 24-week placebo-controlled study was designed to evaluate the efficacy and safety of sitagliptin (100 mg once daily) added to glimepiride alone or glimepiride in combination with metformin.
)
The incidence of hypoglycaemia was similar across treatment groups.
(500 mg
Table 2.
1 000 mg
Placebo-corrected mean
)% #
Mean
! #
Mean change from
()
change in HbA1c (%) at
"+ #%)
Study
HbA1c (%)
baseline HbA1c (%)
HbA1c (%)
baseline HbA1c (%) † at Week 24
24 - + &% † ((%) (95% CI) '
Week 24† (95% CI)
"+ (100 mg §
Monotherapy Studies Sitagliptin 100 mg once daily§
"8, 0
8.0
- 0, 5
-0.5
- 0, 6 ‡
-0.6‡
(- 0, 8, - 0, 4) (N= 193) '100 mg - 0, 8 ‡ (N= 229)
(N= 193) Sitagliptin 100 mg once daily (N= 229) Combination Therapy Studies Sitagliptin 100 mg once daily added to
+ * +
8.0
("+"
-0.6