Sitagliptin/Metformin HCl Approved in Europe for Type 2 Diabetes
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Sitagliptin/Metformin HCl Approved in Europe for Type 2 Diabetes

WHITEHOUSE STATION, NJ -- July 22, 2008 -- The European Commission has approved sitagliptin/metformin HCl (Janumet) as a treatment option for type 2 diabetes.

For patients with type 2 diabetes uncontrolled on metformin alone, sitagliptin plus metformin HCl provides weight loss comparable to metformin alone, with no increased risk of hypoglycaemia, oedema, or gastrointestinal disturbances beyond metformin alone.

In clinical studies, the most common adverse reactions reported in >=5% of patients were diarrhoea, upper respiratory tract infection, and headache.

Consistent with the labelling for metformin alone, sitagliptin/metformin HCl is contraindicated in patients with renal disease, renal dysfunction, or abnormal creatinine clearance and in those with acute or chronic metabolic acidosis, including diabetic ketoacidosis.

Consistent with the labelling for metformin alone, the labelling for sitagliptin/metformin HCl contains a boxed warning for lactic acidosis.

SOURCE: GCI Group

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