896-P: Demographic and Glycemic Parameters across Global Regions in Youth with T2D in Clinical Trials of Sitagliptin
Bibliographic record
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.View largeDownload slideView largeDownload slide DisclosureM. 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.FundingMerck & Co., Inc.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.003 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.001 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.005 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".