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Published on 31 May 2012

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CHMP supports Jentadueto for type 2 diabetes

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The Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorisation for Jentadueto, 2.5 mg/850 mg, 2.5 mg/1000 mg, film-coated tablets intended to treat type 2 diabetes mellitus in adults

 

The applicant for this medicinal product is Boehringer Ingelheim International GmbH. 

 

The active substances of Jentadueto (ATC code: A10BD11, Drugs used in diabetes, combinations of oral blood glucose lowering drugs) are linagliptin and metformin hydrochloride.

 

Linagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor. DPP-4 inhibition reduces the cleavage and inactivation of the active (intact) form of the incretin hormone glucagon-like peptide 1 (GLP-1) and glucose dependent insulinotropic polypeptide (GIP), producing an elevation of incretin concentrations that leads to enhancement of glucose dependent insulin secretion and a reduction in glucagon release.

 

This way linagliptin improves glycaemic control by reducing fasting and postprandial glucose concentrations in patients with type 2 diabetes. 

 

Metformin is a biguanide and has an antihyperglycaemic effect, lowering both basal and postprandial plasma glucose concentrations. 

 

It is thought to act via various mechanisms, including decreasing hepatic glucose production, decreasing intestinal absorption of glucose, and improving insulin sensitivity by increasing peripheral glucose uptake and utilisation. 

 

Jentadueto combines these two glucose-lowering agents with complementary mechanisms of action. 

 

The benefits with Jentadueto are its reduction of blood glucose levels (by means of lowering HbA1c) in patients inadequately controlled by metformin alone or by metformin and a sulphonylurea; and as being equivalent in its glucose-lowering effect compared to the combined use of linagliptin 5 mg once daily and metformin twice daily as an alternative option for patients being treated with these two medicines as separate tablets already. 

 

The most common side effect is an increased incidence of hypoglycaemia (when combined with a sulphonylurea).

 

European medicines Agency



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