Abstract
Objectives: To compare the characteristics of younger (Y, 10-14 yrs) vs. older (O, 15-17 yrs) patients (pts) with T2D in global clinical trials of sitagliptin as initial oral therapy (IOT, NCT01485614) or as add-on to metformin therapy (AMT, NCT01472367, NCT01760447). Methods: Demographic and baseline glycemic parameters were summarized by age group for pts in the studies (Table). Results: The proportion of females was higher in Y groups and that of Whites greater in O groups. All groups had similar BMI percentiles, despite the Y group being shorter, with lower weight and BMI. Duration of T2D was similar across age groups in the IOT study, but duration was less in Y vs. O in AMT studies. Baseline A1C and FPG were comparable across age groups within a study type. Conclusions: The female preponderance reported in youth with T2D (e.g., https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3038479/) was more apparent in Y groups; it is possible that the proportion of females is lower in O groups, approaching the situation in adults where sex distribution is uniform. Both Y and O pts had similar BMI percentiles. While glycemic parameters were similar across age groups within a study type, duration of diabetes was less in Y pts in AMT studies, suggesting that the need for an additional antihyperglycemic agent may occur sooner in pts diagnosed at a younger age. Disclosure R. S. Newfield: Consultant; Self; Merck Sharp & Dohme Corp. Z. Xu: Employee; Self; Merck & Co., Inc., Stock/Shareholder; Self; Merck & Co., Inc. L. W. Scherer: 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. K. D. Kaufman: Employee; Self; Merck & Co., Inc., Stock/Shareholder; Self; Merck & Co., Inc. P. Zeitler: Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Daiichi Sankyo, Eli Lilly and Company, Janssen Research & Development, LLC, Merck & Co., Inc. R. Shankar: Employee; Self; AstraZeneca, Merck Sharp & Dohme Corp. A. Deeb: None. M. Y. Jalaludin: Advisory Panel; Self; Novo Nordisk, Research Support; Self; Novo Nordisk. R. Garcia: None. Y. Samoilova: None. C. A. Rosario: None. N. Shehadeh: Advisory Panel; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Novo Nordisk, Sanofi, Research Support; Self; Novo Nordisk, Speaker’s Bureau; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Novo Nordisk, Sanofi. C. K. Saha: None. Y. Zhang: Employee; Self; Merck & Co., Inc., Stock/Shareholder; Self; Merck & Co., Inc. Funding Merck & Co., Inc.
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