Efficib

sitagliptin / metformin

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This is a summary of the European public assessment report (EPAR) for Efficib. 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 Efficib.

What is Efficib?

Efficib is a medicine that contains two active substances, sitagliptin and metformin hydrochloride. It is available as tablets (50 mg sitagliptin / 850 mg metformin hydrochloride; and 50 mg sitagliptin / 1,000 mg metformin hydrochloride).

What is Efficib used for?

Efficib 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:

  • in patients who are not satisfactorily controlled on metformin (an antidiabetes 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 antidiabetes medicine) in patients who are not satisfactorily controlled on this medicine and metformin.

The medicine can only be obtained with a prescription.

How is Efficib used?

Efficib is taken twice a day. The strength of tablet to use depends on the dose of the other antidiabetes medicines that the patient was taking before. If Efficib 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. Efficib should be taken with food to avoid any stomach problems caused by metformin.

How does Efficib work?

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 substances in Efficib, sitagliptin and metformin hydrochloride, each have a different mode of action.

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 the 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. Sitagliptin has been authorised in the European Union (EU) as Januvia and Xelevia since 2007, and as Tesavel since 2008. Metformin works mainly by inhibiting glucose production and reducing its absorption in the gut.

Metformin has been available in the EU since the 1950s. As a result of the action of both active substances, blood glucose levels are reduced and this helps to control type-2 diabetes.

How has Efficib been studied?

Sitagliptin on its own as Januvia / Xelevia / Tesavel can be used with metformin, and with both metformin and a sulphonylurea, in type-2-diabetes patients. The company presented the results of three studies of Januvia / Xelevia to support the use of Efficib in patients who were not satisfactorily controlled on their existing metformin treatment.

Two of the studies looked at sitagliptin as an add-on to metformin: the first compared it with placebo (a dummy treatment) in 701 patients, and the second compared it with glipizide (a sulphonylurea) in 1,172 patients. The third study compared sitagliptin with placebo, when used as an add-on to glimepiride (another sulphonylurea), with or without metformin, in 441 patients.

The results of three further studies were used to support the use of Efficib. The first included 1,091 patients who were not satisfactorily controlled on diet and exercise alone and compared the effect of Efficib with that of metformin or sitagliptin alone. The second included 278 patients who were not satisfactorily controlled on the combination of metformin and rosiglitazone (a PPAR-gamma agonist) and compared the effects of adding sitagliptin or placebo. The third included 641 patients who were not satisfactorily controlled on a stable dose of insulin, three quarters of whom were also taking metformin. This study also compared the effects of adding sitagliptin or placebo.

In all of the studies, the main measure of effectiveness was the change in the levels of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.

The company also carried out additional studies to show that the active substances in Efficib are absorbed by the body in the same way as the two medicines given separately.

What benefit has Efficib shown during the studies?

Efficib was more effective than metformin alone. Adding 100 mg sitagliptin to metformin reduced HbA1c levels by 0.67% (from around 8.0%) after 24 weeks, compared with a fall of 0.02% in the patients adding placebo. The effectiveness of adding sitagliptin to metformin was similar to that of adding glipizide. In the study in which sitagliptin was added to glimepiride and metformin, the levels of HbA1c were reduced by 0.59% after 24 weeks, compared with an increase of 0.30% in the patients adding placebo.

In the first of the three further studies, Efficib was more effective than metformin or sitagliptin alone.

In the second, HbA1c levels were reduced by 1.03% after 18 weeks in patients adding sitagliptin to metformin and rosiglitazone, compared with a fall of 0.31% in those adding placebo. Finally, they were reduced by 0.59% after 24 weeks in patients adding sitagliptin to insulin, compared with a fall of 0.03% in those adding placebo. There was no difference in this effect between the patients also taking metformin and those not taking it.

What is the risk associated with Efficib?

The most common side effect with Efficib (seen in between 1 and 10 patients in 100) is nausea (feeling sick). For the full list of all side effects reported with Efficib, see the package leaflet.

Efficib must not be used in people who are hypersensitive (allergic) to sitagliptin, metformin or any of the other ingredients. It must not be used in patients who have diabetic ketoacidosis or pre-coma (dangerous conditions that can occur in diabetes), problems with the kidneys or liver, conditions that may affect the kidneys, or a disease that causes a reduced supply of oxygen to the tissues such as failure of the heart or lungs or a recent heart attack. It must also not be used in patients who consume excessive amounts of alcohol or are alcoholic, or in women who are breast-feeding. For the full list of restrictions, see the package leaflet.

Why has Efficib been approved?

The CHMP decided that Efficib’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Other information about Efficib

The European Commission granted a marketing authorisation valid throughout the EU for Efficib on 16 July 2008.

For more information about treatment with Efficib, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Efficib : EPAR - Summary for the public BG = bălgarski 2009-12-08 2013-07-05
Efficib : EPAR - Summary for the public ES = español 2009-12-08 2013-07-05
Efficib : EPAR - Summary for the public CS = čeština 2009-12-08 2013-07-05
Efficib : EPAR - Summary for the public DA = dansk 2009-12-08 2013-07-05
Efficib : EPAR - Summary for the public DE = Deutsch 2009-12-08 2013-07-05
Efficib : EPAR - Summary for the public ET = eesti keel 2009-12-08 2013-07-05
Efficib : EPAR - Summary for the public EL = elliniká 2009-12-08 2013-07-05
Efficib : EPAR - Summary for the public EN = English 2009-12-08 2013-07-05
Efficib : EPAR - Summary for the public FR = français 2009-12-08 2013-07-05
Efficib : EPAR - Summary for the public IT = italiano 2009-12-08 2013-07-05
Efficib : EPAR - Summary for the public LV = latviešu valoda 2009-12-08 2013-07-05
Efficib : EPAR - Summary for the public LT = lietuvių kalba 2009-12-08 2013-07-05
Efficib : EPAR - Summary for the public HU = magyar 2009-12-08 2013-07-05
Efficib : EPAR - Summary for the public MT = Malti 2009-12-08 2013-07-05
Efficib : EPAR - Summary for the public NL = Nederlands 2009-12-08 2013-07-05
Efficib : EPAR - Summary for the public PL = polski 2009-12-08 2013-07-05
Efficib : EPAR - Summary for the public PT = português 2009-12-08 2013-07-05
Efficib : EPAR - Summary for the public RO = română 2009-12-08 2013-07-05
Efficib : EPAR - Summary for the public SK = slovenčina 2009-12-08 2013-07-05
Efficib : EPAR - Summary for the public SL = slovenščina 2009-12-08 2013-07-05
Efficib : EPAR - Summary for the public FI = suomi 2009-12-08 2013-07-05
Efficib : EPAR - Summary for the public SV = svenska 2009-12-08 2013-07-05

This EPAR was last updated on 16/08/2017 .

Authorisation details

Product details

Product details for Efficib
NameEfficib
Agency product numberEMEA/H/C/000896
Active substance

sitagliptin / metformin hydrochloride

International non-proprietary name (INN) or common name

sitagliptin / metformin

Therapeutic area Diabetes Mellitus, Type 2
Anatomical therapeutic chemical (ATC) code A10BD07

Publication details

Publication details for Efficib
Marketing-authorisation holder

Merck Sharp & Dohme Ltd

Revision21
Date of issue of marketing authorisation valid throughout the European Union16/07/2008

Contact address:

Merck Sharp & Dohme Ltd
Hertford Road
Hoddesdon
Hertfordshire
EN11 9BU
United Kingdom

Product information

Product information

09/06/2017  Efficib -EMEA/H/C/000896 -WS/1130/G

Name Language First published Last updated
Efficib : EPAR - Product Information SV = svenska 2009-12-08 2017-08-16
Efficib : EPAR - Product Information SV = svenska 2009-12-08 2017-08-16
Efficib : EPAR - Product Information SV = svenska 2009-12-08 2017-08-16
Efficib : EPAR - Product Information SV = svenska 2009-12-08 2017-08-16
Efficib : EPAR - Product Information SV = svenska 2009-12-08 2017-08-16
Efficib : EPAR - Product Information SV = svenska 2009-12-08 2017-08-16
Efficib : EPAR - Product Information SV = svenska 2009-12-08 2017-08-16
Efficib : EPAR - Product Information SV = svenska 2009-12-08 2017-08-16
Efficib : EPAR - Product Information SV = svenska 2009-12-08 2017-08-16
Efficib : EPAR - Product Information SV = svenska 2009-12-08 2017-08-16
Efficib : EPAR - Product Information SV = svenska 2009-12-08 2017-08-16
Efficib : EPAR - Product Information SV = svenska 2009-12-08 2017-08-16
Efficib : EPAR - Product Information SV = svenska 2009-12-08 2017-08-16
Efficib : EPAR - Product Information SV = svenska 2009-12-08 2017-08-16
Efficib : EPAR - Product Information SV = svenska 2009-12-08 2017-08-16
Efficib : EPAR - Product Information SV = svenska 2009-12-08 2017-08-16
Efficib : EPAR - Product Information SV = svenska 2009-12-08 2017-08-16
Efficib : EPAR - Product Information SV = svenska 2009-12-08 2017-08-16
Efficib : EPAR - Product Information SV = svenska 2009-12-08 2017-08-16
Efficib : EPAR - Product Information SV = svenska 2009-12-08 2017-08-16
Efficib : EPAR - Product Information SV = svenska 2009-12-08 2017-08-16
Efficib : EPAR - Product Information SV = svenska 2009-12-08 2017-08-16
Efficib : EPAR - Product Information SV = svenska 2009-12-08 2017-08-16
Efficib : EPAR - Product Information SV = svenska 2009-12-08 2017-08-16
Efficib : EPAR - Product Information SV = svenska 2009-12-08 2017-08-16

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Efficib : EPAR - All Authorised presentations SV = svenska 2009-05-14 2014-03-27
Efficib : EPAR - All Authorised presentations SV = svenska 2009-05-14 2014-03-27
Efficib : EPAR - All Authorised presentations SV = svenska 2009-05-14 2014-03-27
Efficib : EPAR - All Authorised presentations SV = svenska 2009-05-14 2014-03-27
Efficib : EPAR - All Authorised presentations SV = svenska 2009-05-14 2014-03-27
Efficib : EPAR - All Authorised presentations SV = svenska 2009-05-14 2014-03-27
Efficib : EPAR - All Authorised presentations SV = svenska 2009-05-14 2014-03-27
Efficib : EPAR - All Authorised presentations SV = svenska 2009-05-14 2014-03-27
Efficib : EPAR - All Authorised presentations SV = svenska 2009-05-14 2014-03-27
Efficib : EPAR - All Authorised presentations SV = svenska 2009-05-14 2014-03-27
Efficib : EPAR - All Authorised presentations SV = svenska 2009-05-14 2014-03-27
Efficib : EPAR - All Authorised presentations SV = svenska 2009-05-14 2014-03-27
Efficib : EPAR - All Authorised presentations SV = svenska 2009-05-14 2014-03-27
Efficib : EPAR - All Authorised presentations SV = svenska 2009-05-14 2014-03-27
Efficib : EPAR - All Authorised presentations SV = svenska 2009-05-14 2014-03-27
Efficib : EPAR - All Authorised presentations SV = svenska 2009-05-14 2014-03-27
Efficib : EPAR - All Authorised presentations SV = svenska 2009-05-14 2014-03-27
Efficib : EPAR - All Authorised presentations SV = svenska 2009-05-14 2014-03-27
Efficib : EPAR - All Authorised presentations SV = svenska 2009-05-14 2014-03-27
Efficib : EPAR - All Authorised presentations SV = svenska 2009-05-14 2014-03-27
Efficib : EPAR - All Authorised presentations SV = svenska 2009-05-14 2014-03-27
Efficib : EPAR - All Authorised presentations SV = svenska 2009-05-14 2014-03-27
Efficib : EPAR - All Authorised presentations SV = svenska 2009-05-14 2014-03-27
Efficib : EPAR - All Authorised presentations SV = svenska 2009-05-14 2014-03-27
Efficib : EPAR - All Authorised presentations SV = svenska 2009-05-14 2014-03-27

Pharmacotherapeutic group

Drugs used in diabetes

Therapeutic indication

For patients with type-2 diabetes mellitus:

  • Efficib 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.
  • Efficib 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.
  • Efficib is indicated as triple combination therapy with a 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.
  • Efficib 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 dosage of insulin and metformin alone do not provide adequate glycaemic control.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Efficib : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 2009-12-08 2017-08-16
Efficib-H-C-896-A31-1432 : EPAR - Assessment Report - Article 31 SV = svenska 2016-12-22  
Efficib : EPAR - Scientific Conclusion SV = svenska 2016-12-22  
Efficib : EPAR - Scientific Conclusion SV = svenska 2016-12-22  
Efficib : EPAR - Scientific Conclusion SV = svenska 2016-12-22  
Efficib : EPAR - Scientific Conclusion SV = svenska 2016-12-22  
Efficib : EPAR - Scientific Conclusion SV = svenska 2016-12-22  
Efficib : EPAR - Scientific Conclusion SV = svenska 2016-12-22  
Efficib : EPAR - Scientific Conclusion SV = svenska 2016-12-22  
Efficib : EPAR - Scientific Conclusion SV = svenska 2016-12-22  
Efficib : EPAR - Scientific Conclusion SV = svenska 2016-12-22  
Efficib : EPAR - Scientific Conclusion SV = svenska 2016-12-22  
Efficib : EPAR - Scientific Conclusion SV = svenska 2016-12-22  
Efficib : EPAR - Scientific Conclusion SV = svenska 2016-12-22  
Efficib : EPAR - Scientific Conclusion SV = svenska 2016-12-22  
Efficib : EPAR - Scientific Conclusion SV = svenska 2016-12-22  
Efficib : EPAR - Scientific Conclusion SV = svenska 2016-12-22  
Efficib : EPAR - Scientific Conclusion SV = svenska 2016-12-22  
Efficib : EPAR - Scientific Conclusion SV = svenska 2016-12-22  
Efficib : EPAR - Scientific Conclusion SV = svenska 2016-12-22  
Efficib : EPAR - Scientific Conclusion SV = svenska 2016-12-22  
Efficib : EPAR - Scientific Conclusion SV = svenska 2016-12-22  
Efficib : EPAR - Scientific Conclusion SV = svenska 2016-12-22  
Efficib : EPAR - Scientific Conclusion SV = svenska 2016-12-22  
Efficib : EPAR - Scientific Conclusion SV = svenska 2016-12-22  
Efficib : EPAR - Scientific Conclusion SV = svenska 2016-12-22  
Efficib : EPAR - Scientific Conclusion SV = svenska 2016-12-22  
Efficib-H-C-896-II-0004 : EPAR - Assessment Report - Variation SV = svenska 2009-12-08  
CHMP post authorisation summary of positive opinion for Efficib of 24 September 2009 SV = svenska 2009-09-24  
Efficib-H-C-896-II-0013 : EPAR - Assessment Report - Variation SV = svenska 2009-07-06  
CHMP post-authorisation summary of positive opinion for Efficib of 23 April 2009 SV = svenska 2009-04-23  

Initial marketing-authorisation documents

Name Language First published Last updated
Efficib : EPAR - Public assessment report SV = svenska 2008-08-06  
Committee for medicinal products for human use summary of positive opinion for Efficib SV = svenska 2008-04-29