( onotherapy studies one of 18- and one ...)Late Breaking Data Released at ADA Showed that the Investigational,Use of Januvia and Metformin as Initial Combination Therapy,Provided Significant Glucose Lowering Efficacy over 54 Weeks in,Patients with Type 2 Diabetes,Health

onotherapy studies, one of 18- and one of 24-week duration, included patients treated with JANUVIA 100 mg daily, JANUVIA 200 mg daily, and placebo. Two 24-week, placebo-controlled combination studies, one with metformin and one with pioglitazone, were also conducted. In addition to a stable dose of metformin or pioglitazone, patients whose diabetes was not adequately controlled were given either JANUVIA 100 mg daily or placebo. The adverse reactions, reported regardless of investigator assessment of causality in greater than or equal to 5% of patients treated with JANUVIA 100 mg daily as monotherapy or in combination with pioglitazone and more commonly than in patients treated with placebo, are shown in Table 1. Table 1 Placebo-Controlled Clinical Studies of JANUVIA Monotherapy or Combination with Pioglitazone: Adverse Reactions Reported in Greater than or equal to 5% of Patients and More Commonly than in Patients Given Placebo, Regardless of Investigator Assessment of Causality+ ---------------------------------------------------------------------- Number of Patients (%) ---------------------------------------------------------------------- Monotherapy JANUVIA 100 mg Placebo ---------------------------------------------------------------------- N = 443 N = 363 ---------------------------------------------------------------------- Nasopharyngitis 23 (5.2) 12 (3.3) ---------------------------------------------------------------------- Combination with Pioglitazone JANUVIA 100 mg + Placebo + Pioglitazone Pioglitazone ---------------------------------------------------------------------- N = 175 N = 178 ----
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