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An Investigational Study Released at ADA Showed that Initial,Combination Therapy with Januvia (sitagliptin) and Metformin Led to,Improvement in Markers of Beta Cell Function in Patients with Type,2 Diabetes

inical 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 monotherapy 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 R
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