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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

------------------------------------------------------------------ Upper Respiratory Tract Infection 11 (6.3) 6 (3.4) ---------------------------------------------------------------------- Headache 9 (5.1) 7 (3.9) ---------------------------------------------------------------------- + Intent to treat population In patients receiving JANUVIA in combination with metformin, there were no adverse reactions reported regardless of investigator assessment of causality in greater than or equal to 5% of patients and more commonly than in patients given placebo. The overall incidence of hypoglycemia in patients treated with JANUVIA 100 mg was similar to placebo (1.2% vs 0.9%). The incidence of selected gastrointestinal adverse reactions in patients treated with JANUVIA was as follows: abdominal pain (JANUVIA 100 mg, 2.3%; placebo, 2.1%), nausea (1.4%, 0.6%), and diarrhea (3.0%, 2.3%). No clinically meaningful changes in vital signs or in ECG (including in QTc interval) were observed in patients treated with JANUVIA. Laboratory Tests The incidence of laboratory adverse reactions in patients treated with JANUVIA 100 mg was 8.2% compared to 9.8% in patients treated with placebo. Across clinical studies, a small increase in white blood cell count (approximately 200 cells/microL difference in WBC vs placebo; mean baseline WBC approximately 6600 cells/microL) was observed due to an increase in neutrophils. This observation was seen in most but not all studies. This change in laboratory parameters is not considered to be clinically relevant. In a 12-week study of 91 patients with chronic renal insufficiency, 37 patients with moderate renal insufficiency were randomized to JANUVIA 50 mg daily, while 14 patients with the same magnitude of renal impairment were randomized to placebo. Mean (SE) increases in serum creatinine were observed in patients treated wi
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