New data presented at the American Diabetes Association 68th annual scientific sessions showed initial combination therapy with US drug major Merck & Co's Januvia (sitagliptin) and metformin substantially improved selected markers of beta cell function and significantly reduced blood sugar levels (as measured by HbA1c) at one year and in data recently unblinded at two years.
The agent is indicated as an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes. It should not be used in people with type 1 diabetes or for the treatment of diabetic ketoacidosis, and has not been studied in combination with insulin. Januvia is contraindicated for patients with history of a serious hypersensitivity reaction to the product, including anaphylaxis and angioedema.
"We wanted to evaluate the combined and complementary effects of sitagliptin and metformin on the critical role of beta cell function in type 2 diabetes as well as to assess efficacy out to two years," said John Amatruda, senior vice president, research, diabetes and obesity franchise at Merck. The European Medicines Agency (EMEA) approved Januva in April 2007, the first dipeptidyl peptidase-4 inhibitor available in Europe.
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