ion, the reductions in A1C and FPG with JANUVIA compared to placebo were generally similar to those observed in other monotherapy studies. (See Clinical Pharmacology (12.3).) 14.2 Combination Therapy Combination Therapy with Metformin A total of 701 patients with type 2 diabetes participated in a 24-week, randomized, double-blind, placebo-controlled study designed to assess the efficacy of JANUVIA in combination with metformin. Patients already on metformin (N=431) at a dose of at least 1500 mg per day were randomized after completing a 2-week single-blind placebo run-in period. Patients on metformin and another antihyperglycemic agent (N = 229) and patients not on any antihyperglycemic agents (off therapy for at least 8 weeks, N = 41) were randomized after a run-in period of approximately 10 weeks on metformin (at a dose of at least 1500 mg per day) in monotherapy. Patients were randomized to the addition of either 100 mg of JANUVIA or placebo, administered once daily. Patients who failed to meet specific glycemic goals during the studies were treated with pioglitazone rescue. In combination with metformin, JANUVIA provided significant improvements in A1C, FPG, and 2-hour PPG compared to placebo with metformin (Table 3). Rescue glycemic therapy was used in 5% of patients treated with JANUVIA 100 mg and 14% of patients treated with placebo. A similar decrease in body weight was observed for both treatment groups. Table 3 Glycemic Parameters at Final Visit (24-Week Study) for JANUVIA in Combination with Metformin+ ---------------------------------------------------------------------- JANUVIA Placebo + 100 mg + Metformin Metformin ----------------------------------------------------------- --------- A1C (%)
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