1035-P: Real-World Safety and Effectiveness of Insulin Glargine 300 U/mL (Gla-300) in People with Type 2 Diabetes (T2DM) Who Fast during Ramadan: Regional Analysis of the ORION Study
Bibliographic record
Abstract
ORION, a prospective observational study, evaluated the safety and effectiveness of the second-generation basal insulin analog Gla-300 in people who fast during Ramadan. Adults (≥18 years) with T2DM who intended to fast for ≥15 days during Ramadan, had taken Gla-300 for ≥8 weeks before inclusion and intended to continue during Ramadan were enrolled in 11 countries (grouped by region; Table). Mean (SD) number of fasting days was 30.1 (3.2). Mean diabetes duration ranged from 7.9 to 13.5 years and ≥77.5% had moderate/low risk associated with fasting (investigator-assessed). Proportions of people with ≥1 severe and/or symptomatic documented hypoglycemia event were low for the overall population and in Groups 1-3; 1 severe hypoglycemia event was reported in pre-Ramadan. Glycemic control improved pre- to post-Ramadan in Groups 1-3 and Gla-300 dose adjustments were minimal. In Canada, 24% of people had ≥1 severe and/or symptomatic documented hypoglycemia event in Ramadan; there was no change in glycemic control, but pre-Ramadan HbA1c target achievement was high (30.4%). In this real-world study, people with T2DM who received Gla-300 and fasted for Ramadan generally had low incidence of hypoglycemia, with no severe events in Ramadan, and slightly improved glycemic control; results from Canada varied, possibly due to longer fasting hours. Disclosure M. Hassanein: Advisory Panel; Self; Novo Nordisk A/S. Speaker’s Bureau; Self; Lilly Diabetes, Merck Sharp & Dohme Corp., Novo Nordisk A/S, Sanofi. M.A. Buyukbese: Consultant; Self; Sanofi. R. Malek: None. V. Pilorget: Employee; Self; Sanofi. M. Naqvi: Employee; Self; Sanofi. B. Berthou: None. I. Shaltout: Advisory Panel; Self; Sanofi, Novartis, MSD, Astra Zeneca, Novo Nordisk, Lilly, Servier and Abbott. Speaker’s Bureau; Self; Sanofi, Novartis, MSD, Astra Zeneca, Novo Nordisk, Lilly, Servier and Abbott. R. Sahay: Advisory Panel; Self; Boehringer Ingelheim, Dr. Reddy’s Laboratories, Eli Lilly and Company, Sanofi. Speaker’s Bureau; Self; Boehringer Ingelheim, Eli Lilly and Company, Novo Nordisk A/S, Sanofi. Funding Sanofi; World Health Organization (CTRI/2019/02/017636)
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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 | 0.005 | 0.006 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.002 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 0.000 |
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".