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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

osage adjustment based upon renal function, assessment of renal function is recommended prior to initiation of JANUVIA and periodically thereafter. Creatinine clearance can be estimated from serum creatinine using the Cockcroft-Gault formula. (See Clinical Pharmacology (12.3).) 3 DOSAGE FORMS AND STRENGTHS -- 100 mg tablets are beige, round, film-coated tablets with "277" on one side. -- 50 mg tablets are light beige, round, film-coated tablets with "112" on one side. -- 25 mg tablets are pink, round, film-coated tablets with "221" on one side. 4 CONTRAINDICATIONS None. 5 WARNINGS AND PRECAUTIONS Use in Patients with Renal Insufficiency: A dosage adjustment is recommended in patients with moderate or severe renal insufficiency and in patients with ESRD requiring hemodialysis or peritoneal dialysis. (See Dosage and Administration (2.2); Clinical Pharmacology (12.3).) Use with Medications Known to Cause Hypoglycemia: In clinical trials of JANUVIA as monotherapy and JANUVIA as part of combination therapy with metformin or pioglitazone, rates of hypoglycemia reported with JANUVIA were similar to rates in patients taking placebo. The use of JANUVIA in combination with medications known to cause hypoglycemia, such as sulfonylureas or insulin, has not been adequately studied. 6 ADVERSE REACTIONS Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. 6.1 Clinical Trials Experience In controlled clinical studies as both monotherapy and combination therapy, the overall incidence of adverse reactions with JANUVIA was similar to that reported with placebo. Discontinuation of therapy due to clinical adverse reactions was also similar to placebo. Two placebo-controlled m
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