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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

- -------- Difference from placebo (adjusted -20ss. -17ss. mean++) (95% CI) (-31, (-24, -9) -10) ------------------------------------------- -------- -------- -------- 2-hour PPG (mg/dL) % % N = 201 N = 204 ------------------------------------------- -------- -------- -------- Baseline (mean) 257 271 ------------------------------------------- -------- -------- -------- Change from baseline (adjusted mean++) -49 -2 ------------------------------------------- -------- -------- -------- Difference from placebo (adjusted -47ss. mean++) (95% CI) (-59, -34) ------------------------------------------- -------- -------- -------- + Intent to Treat Population using last observation on study prior to metformin rescue therapy. ++ Least squares means adjusted for prior antihyperglycemic therapy status and baseline value. ss. pless than0.001 compared to placebo. % Data not available. Additional Monotherapy Study A multinational, randomized, double-blind, placebo-controlled study was also conducted to assess the safety and tolerability of JANUVIA in 91 patients with type 2 diabetes and chronic renal insufficiency (creatinine clearance less than 50 mL/min). Patients with moderate renal insufficiency received 50 mg daily of JANUVIA and those with severe renal insufficiency or with ESRD on hemodialysis or peritoneal dialysis received 25 mg daily. In this study, the safety and tolerability of JANUVIA were generally similar to placebo. A small increase in serum creatinine was reported in patients with moderate renal insufficiency treated with JANUVIA relative to those on placebo. In addit
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