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磷酸西格列汀床-安全性han.ppt

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磷酸西格列汀床-安全性han

* * The efficacy and safety of sitagliptin has been assessed in 5 multinational, randomized, placebo-controlled, double-blind, phase III studies and one additional phase II study in Japan for the treatment of patients with type 2 diabetes and poor glycemic control. Three monotherapy, placebo-controlled studies 18 weeks1 24 weeks2 12 weeks3 (phase II) Three add-on therapy studies Metformin 24 weeks4 52-week active control5 Pioglitazone 24 weeks6 (peroxisome proliferator activated receptor [PPAR?] agonist)7 References 1. Raz I, Hanefeld M, Xu L, et al, for the Sitagliptin Study 023 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin as monotherapy in patients with type 2 diabetes mellitus. Diabetologia. 2006;49:2564–2571. 2. Aschner P, Kipnes M, Lunceford J, et al, for the Sitagliptin Study 021 Group. Effect of the dipeptidyl peptidase-4 inhibitor sitagliptin as monotherapy on glycemic control in patients with type 2 diabetes. Diabetes Care. 2006;29:2632–2637. 3. Nonaka K, Kakikawa T, Sato A, et al. Efficacy and safety of sitagliptin monotherapy in Japanese patients with type 2 diabetes. Diabetes Res Clin Pract. 2008;79(2):291–298. 4. Charbonnel B, Karasik A, Liu J, et al, for the Sitagliptin Study 020 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin added to ongoing metformin therapy in patients with type 2 diabetes inadequately controlled with metformin alone. Diabetes Care. 2006;29:2638–2643. 5. Nauck MA, Meininger G, Sheng D, et al, for the Sitagliptin Study 024 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor, sitagliptin, compared with the sulfonylurea, glipizide, in patients with type 2 diabetes inadequately controlled on metformin alone: a randomized, double-blind, non-inferiority trial. Diabetes Obes Metab. 2007;9:194–205. 6. Rosenstock J, Brazg R, Andryuk P, et al, for the Sitagliptin Study 019 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin