Januvia
Authorised
sitagliptin
Medicine
Human
Authorised
This is a summary of the European public assessment report (EPAR) for Januvia. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Januvia.
Januvia is a medicine that contains the active substance sitagliptin. It is available as tablets (25, 50 and 100 mg).
Januvia is used in patients with type-2 diabetes to improve the control of blood glucose (sugar) levels. It is used in addition to diet and exercise in the following ways:
The medicine can only be obtained with a prescription.
Januvia is taken at a dose of 100 mg once a day. If Januvia is taken with a sulphonylurea or insulin, the dose of the sulphonylurea or insulin may need to be lowered to reduce the risk of hypoglycaemia (low blood sugar levels).
In patients with moderately or severely reduced kidney function the dose of Januvia should be reduced.
Type-2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively. The active substance in Januvia, sitagliptin, is a dipeptidyl-peptidase-4 (DPP-4) inhibitor. It works by blocking the breakdown of ‘incretin’ hormones in the body. These hormones are released after a meal and stimulate the pancreas to produce insulin. By increasing levels of incretin hormones in the blood, sitagliptin stimulates the pancreas to produce more insulin when blood glucose levels are high. Sitagliptin does not work when the blood glucose is low. Sitagliptin also reduces the amount of glucose made by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon. Together, these processes reduce blood glucose levels and help to control type-2 diabetes.
Januvia was studied in nine studies involving almost 6,000 patients with type-2 diabetes whose blood glucose levels were not adequately controlled:
In all of the 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.
Januvia was more effective than placebo when it was taken alone or in combination with other antidiabetes medicines. In patients taking Januvia on its own, HbA1c levels fell from around 8.0% at the start of the studies by 0.48% after 18 weeks and 0.61% after 24 weeks. In contrast, they rose by 0.12% and 0.18%, respectively, in the patients taking placebo. Adding Januvia to metformin reduced HbA1c levels by 0.67% after 24 weeks, compared with a fall of 0.02% in the patients adding placebo. When added to pioglitazone, Januvia reduced HbA1c levels by 0.85% after 24 weeks, compared with a fall of 0.15% in the patients adding placebo.
In the studies comparing Januvia with other medicines, the effectiveness of adding Januvia to metformin was similar to that of adding glipizide. When taken on their own, Januvia and metformin produced similar reductions in HbA1c levels, but the effectiveness of Januvia seemed to be slightly lower than that of metformin.
In the additional studies, adding Januvia to glimepiride (with or without metformin) led to a reduction in HbA1c levels of 0.45% after 24 weeks, compared with an increase of 0.28% in the patients adding placebo. HbA1c levels were reduced by 1.03% after 18 weeks in patients adding Januvia to metformin and rosiglitazone, compared with a fall of 0.31% in those adding placebo. Finally, they were reduced by 0.59% in patients adding Januvia to insulin (with or without metformin), compared with a fall of 0.03% in those adding placebo.
Serious side effects reported with Januvia include pancreatitis (inflammation of the pancreas) and hypersensitivity (allergic reactions). Hypoglycaemia has been reported in combination with a sulphonylurea in 4.7-13.8% of patients and with insulin in 9.6% of patients. For the full list of all side effects reported with Januvia, see the package leaflet.
Januvia must not be used in people who are hypersensitive (allergic) to sitagliptin or any of the other ingredients.
The CHMP decided that Januvia’s benefits are greater than its risks and recommended that it be given marketing authorisation.
The European Commission granted a marketing authorisation valid throughout the European Union for Januvia on 21 March 2007.
For more information about treatment with Januvia, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
This medicine’s product information is available in all official EU languages.
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Product information documents contain:
For adult patients with type-2 diabetes mellitus, Januvia is indicated to improve glycaemic control:
Januvia is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.