| Abstrakt: |
The efficacy/safety of sitagliptin (SITA) has been studied in global populations. This post hoc pooled analysis of 20 placebo (PBO)-controlled studies reports data collected specifically in East Asian populations (EAP). Results were summarized for overall EAP and subgroups defined by geography. Change from baseline in A1C was analyzed at week 12 using ANCOVA model with treatment, study, and baseline A1C terms. A1C values following initiation of rescue medication were excluded. Missing A1C values were imputed using LOCF method. Baseline characteristics were generally balanced across treatments (mean A1C 8.5%, age 55-56 years, BMI 25 kg/m2, FPG 177-179 mg/dL, duration T2D 7-8 years). After 12 weeks of SITA, all populations showed significant A1C reductions vs. PBO (Table) and the largest PBO-adjusted reduction was seen in the Japan subgroup. PBO treatment was associated with reductions in A1C in China Mainland (CM), but with increases in Japan. The percentages of SITA-treated pts with A1C <7% were 18.9%, 14.2%, 37.4% and 30.4% for overall EAP, CM, Japan and Other East Asian subgroups, respectively (all p<0.001 vs. PBO). The incidences of hypoglycemia (i.e., symptomatic/asymptomatic) were 13/981 [1.3%] and 5/816 [0.6%] for SITA and PBO, respectively. These results are consistent with previous findings in global populations. Disclosure: J.M. Conceicao: Employee; Self; Merck Sharp & Dohme Corp. Stock/Shareholder; Self; Merck Sharp & Dohme Corp. C.D. Gonzalez: Employee; Self; Merck & Co., Inc. Stock/Shareholder; Self; Merck & Co., Inc. S.S. Engel: Employee; Self; Merck & Co., Inc. Stock/Shareholder; Self; Merck & Co., Inc. J. Ahn: Employee; Self; Merck Sharp & Dohme Corp. Stock/Shareholder; Self; Merck Sharp & Dohme Corp. S. Tokita: Employee; Self; Merck Sharp & Dohme Corp. Stock/Shareholder; Self; Merck Sharp & Dohme Corp. Y. Zhang: Employee; Self; Merck Sharp & Dohme Corp. R. Zhang: Employee; Self; Merck Sharp & Dohme Corp. R.L. Lam: Employee; Self; Merck & Co., Inc. A. Pong: None. Funding: Merck & Co., Inc. [ABSTRACT FROM AUTHOR] |
