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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

-on therapy to a sulfonylurea when the single agent alone does not provide adequate glycemic control and as add-on therapy to the combination of a sulfonylurea plus metformin when dual therapy does not provide adequate glycemic control. The FDA is reviewing the sNDA for these indications and Merck expects FDA action by mid-October.

A pooled analysis of 5,141 patients showed overall incidence of adverse experiences, incidence of serious adverse experiences, and incidence of discontinuations due to adverse experiences were similar in the JANUVIA and non-exposed groups for up to two years (Poster #534-P)

The safety and tolerability of JANUVIA was assessed by pooling data from nine completed Phase IIB and III studies, including the studies discussed above, ranging from 24 to 104 weeks in duration, and including 5,141 patients treated with either JANUVIA 100 mg daily (n=2,786) or other treatments (placebo or an active comparator) (n=2,355). The studies assessed JANUVIA as monotherapy, initial combination therapy with metformin, or add-on to another oral agent (metformin, pioglitazone, sulfonylurea, or sulfonylurea and metformin).

JANUVIA 100 mg daily was generally well-tolerated as monotherapy, as initial combination therapy, or as add-on therapy. For adverse experiences (either clinical or laboratory), the overall incidence of adverse experiences, the incidence of serious adverse experiences, and the incidence of discontinuations due to adverse experiences were similar in the JANUVIA treated patients and in patients who received other therapies (patients on placebo or active comparator). Drug-related adverse experiences were higher in the non-exposed group due to hypoglycemia reported in sulfonylurea-treated patients (since studies in which a sulfonylurea agent was a treatment in patients not receiving JANUVIA were included in this pooled analysis).

Specific clinical adverse experiences, expressed as a rate of greater than or equal to 1 event
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