Visual Abstract

Objectives: To compare baseline characteristics of 10-17 yr old patients (pts) with T2D from different regions in 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 of pts randomized in the US or Canada (NA), Latin America (LA), Europe or the Middle East (EM), or Asia Pacific (AP) were summarized by region (Table).

Results: The proportion of males varied by region. While racial and ethnic distributions were generally reflective of region, the proportion of Whites in NA was higher than in other reports (e.g., ncbi.nlm.nih.gov/pmc/articles/PMC3038479). AP pts were youngest. Consistent with age, pts in AP were shorter, with lower weight and BMI across trials; however, median BMI percentile was >98% across regions and trial types. Median A1C and FPG ranged from 7.1-7.4% and 118-130.5 mg/dL (IOT) and 7.7-7.9% and 125.5-143.5 mg/dL (AMT). Despite having the lowest FPG, pts in AP (IOT) had the highest A1C.

Conclusions: Despite regional differences in race, sex, and anthropometrics, pts were uniformly obese. Baseline glycemic parameters by region were generally comparable, although the younger age (all trials) and lower FPG and higher A1C (IOT) in AP pts may reflect a difference in the pathophysiology of T2D, with greater post-meal rather than fasting dysglycemia.

Disclosure

M. Y. Jalaludin: Advisory Panel; Self; Novo Nordisk, Research Support; Self; Novo Nordisk. Y. Zhang: Employee; Self; Merck & Co., Inc., Stock/Shareholder; Self; Merck & Co., Inc. 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. R. Shankar: Employee; Self; AstraZeneca, Merck Sharp & Dohme Corp. A. Deeb: None. P. Zeitler: Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Daiichi Sankyo, Eli Lilly and Company, Janssen Research & Development, LLC, Merck & Co., Inc. R. Garcia: None. R. S. Newfield: Consultant; Self; Merck Sharp & Dohme Corp. 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.

Funding

Merck & Co., Inc.

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