Basic Information
A10BD07
metformin and sitagliptin
Drugs used in diabetes
Therapeutic indication
For adult patients with type 2 diabetes mellitus:
- It is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin.
- It is indicated in combination with a sulphonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea.
- It is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (PPAR?) agonist (i.e., a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a PPAR? agonist.
- It is also indicated as add-on to insulin (i.e., triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control.
Overview Summary
Sitagliptin/Metformin hydrochloride Accord is a medicine used to control blood glucose (sugar) levels in adults with type 2 diabetes. It is used together with diet and exercise in the following ways:
- in patients whose blood glucose levels are not satisfactorily controlled with metformin (a diabetes medicine) used on its own;
- in patients who are already taking a combination of sitagliptin and metformin as separate tablets;
- in combination with a sulphonylurea, a PPAR-gamma agonist such as a thiazolidinedione, or insulin (other types of diabetes medicines) in patients whose blood glucose levels are not satisfactorily controlled with either of these medicines and metformin.
Sitagliptin/Metformin hydrochloride Accord contains the active substances sitagliptin and metformin hydrochloride and is a ‘generic medicine’. This means that Sitagliptin/Metformin hydrochloride Accord contains the same active substances and works in the same way as a ‘reference medicine’ already authorised in the EU called Janumet. For more information on generic medicines, see the question-and-answer document here.
Active Substances (3)
metformin hydrochloridesitagliptin hydrochloride monohydrate
metformin hydrochloride
sitagliptin hydrochloride monohydrate
Documents (10)
Sitagliptin / Metformin hydrochloride Accord : EPAR - Public assessment report
August 3, 2022
INITIAL_MARKETING_AUTHORISATION_DOCUMENTS
Sitagliptin / Metformin hydrochloride Accord : EPAR - Product information
August 3, 2022
DRUG_PRODUCT_INFORMATION
Sitagliptin / Metformin hydrochloride Accord : EPAR - Procedural steps taken and scientific information after authorisation
May 19, 2025
CHANGES_SINCE_INITIAL_AUTHORISATION
Sitagliptin / Metformin hydrochloride Accord : EPAR - Medicine overview
August 3, 2022
OVERVIEW_DOCUMENT
Sitagliptin / Metformin hydrochloride Accord : EPAR - Risk-management-plan summary
August 3, 2022
RISK_MANAGEMENT_PLAN_SUMMARY
Sitagliptin / Metformin hydrochloride Accord : EPAR - Procedural steps taken and scientific information after authorisation (archive)
September 1, 2022
CHANGES_SINCE_INITIAL_AUTHORISATION
Sitagliptin / Metformin hydrochloride Accord : EPAR - Public assessment report
August 3, 2022
CHANGES_SINCE_INITIAL_AUTHORISATION
CHMP summary of positive opinion for Sitagliptin / Metformin hydrochloride Accord
May 20, 2022
INITIAL_MARKETING_AUTHORISATION_DOCUMENTS
CHMP summary of positive opinion for Sitagliptin / Metformin hydrochloride Accord
May 20, 2022
CHANGES_SINCE_INITIAL_AUTHORISATION
Sitagliptin / Metformin hydrochloride Accord : EPAR - All authorised presentations
August 3, 2022
AUTHORISED_PRESENTATIONS
Overview Q&A (7)
Question
How is Sitagliptin / Metformin hydrochloride Accord used?
Answer
Sitagliptin/Metformin hydrochloride Accord is available as tablets and can only be obtained with a prescription. The medicine is taken twice a day and the dose depends on the dose of the other diabetes medicines that the patient was taking before. If Sitagliptin/Metformin hydrochloride Accord is taken with a sulphonylurea or insulin, the dose of the sulphonylurea or insulin may need to be lowered to avoid hypoglycaemia (low blood sugar levels).
The maximum dose of sitagliptin is 100 mg a day. Sitagliptin/Metformin hydrochloride Accord should be taken with food to avoid any stomach problems caused by metformin.
For more information about using Sitagliptin/Metformin hydrochloride Accord, see the package leaflet or contact your doctor or pharmacist.
Question
Why is Sitagliptin / Metformin hydrochloride Accord authorised in the EU?
Answer
The European Medicines Agency concluded that, in accordance with EU requirements, Sitagliptin/Metformin hydrochloride Accord has been shown to have comparable quality and to be bioequivalent to Janumet. Therefore, the Agency’s view was that, as for Janumet, the benefits of Sitagliptin/Metformin hydrochloride Accord outweigh the identified risks and it can be authorised for use in the EU.
Question
How does Sitagliptin / Metformin hydrochloride Accord work?
Answer
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 where the body is unable to use insulin effectively. The active substances in Sitagliptin/Metformin hydrochloride Accord each have a different mode of action to help correct this.
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 blood glucose levels are low. Sitagliptin also reduces the amount of glucose made by the liver by increasing insulin levels and decreasing the levels of the hormone glucagon.
Metformin works mainly by inhibiting glucose production and reducing its absorption in the gut.
Together, these processes reduce blood glucose levels and help to control type 2 diabetes.
Question
What are the benefits and risks of Sitagliptin / Metformin hydrochloride Accord?
Answer
Because Sitagliptin/Metformin hydrochloride Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.
Question
What measures are being taken to ensure the safe and effective use of Sitagliptin / Metformin hydrochloride Accord?
Answer
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Sitagliptin/Metformin hydrochloride Accord have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Sitagliptin/Metformin hydrochloride Accord are continuously monitored. Suspected side effects reported with Sitagliptin/Metformin hydrochloride Accord are carefully evaluated and any necessary action taken to protect patients.
Question
Other information about Sitagliptin / Metformin hydrochloride Accord
Answer
Sitagliptin / Metformin hydrochloride Accord received a marketing authorisation valid throughout the EU on 22 July 2022.
Question
How has Sitagliptin / Metformin hydrochloride Accord been studied?
Answer
Studies on the benefits and risks of the active substances in the authorised use have already been carried out with the reference medicine, Janumet, and do not need to be repeated for Sitagliptin/Metformin hydrochloride Accord.
As for every medicine, the company provided data on the quality of Sitagliptin/Metformin hydrochloride Accord. The company also carried out studies that showed that it is ‘bioequivalent’ to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.