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JANUVIA is indicated, as an adjunct to diet and exercise, to improve glycemic control in patients with type 2 diabetes mellitus. JANUVIA is also indicated to improve glycemic control, in combination with metformin or a thiazolidinediones. In clinical trials, the company revealed that JANUVIA demonstrated an overall incidence of side effects comparable to placebo.
According to the company, the most common side effects reported with JANUVIA were stuffy or runny nose and sore throat, upper respiratory infection, and headache. The Whitehouse Station, New Jersey-based company noted that JANUVIA has been approved as monotherapy and as add-on therapy to either of two other types of oral diabetes medications, metformin or thiazolidinediones ( | | | ), to improve blood sugar (glucose) control in patients with type 2 diabetes when diet and exercise is not enough. In two double-blind, placebo-controlled studies of 24 weeks and 18 weeks in patients with mild to moderate baseline A1C levels, Merck said JANUVIA 100 mg once-daily showed significant mean differences in A1C from placebo of -0.
8% and -0.6%, respectively. In separate 24-week studies of patients with type 2 diabetes who were inadequately controlled on either metformin or pioglitazone alone, JANUVIA 100 mg once daily provided a complementary effect.
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