1102-P: Impact of Treatment with Sotagliflozin on the Incidence of Severe Hypoglycemia in Patients with T1D
Bibliographic record
Abstract
Objective: Severe hypoglycemia (SH) is an acute and life-threatening complication of T1D. Factors impacting the risk of SH include A1C, eGFR, insulin dose changes, and use of MDI versus CSII. An adjunctive treatment that simultaneously improves glycemic control and reduces SH across broad groups would be beneficial for patients (pts) with T1D. Methods: Data were pooled from two, 52-week, placebo (PBO)-controlled studies in adults with T1D in the overall population and in prespecified subgroups (Table). SH was defined using Level 3 hypoglycemia criteria and all events were independently adjudicated. Results reflect exposure-adjusted incidence rate per 100 patient-years. Results: Sotagliflozin (SOTA) 400 mg treatment significantly reduced the overall incidence of SH by 41% vs. placebo (relative risk [95% CI] 0.59 [0.35, 0.98]). A dose-responsive reduction was observed in the overall population, and maintained in subgroup analyses (Table), regardless of baseline A1C, eGFR, or percentage reduction in daily insulin dose. Patients using MDI versus CSII alone are generally at higher risk of SH. SOTA 400mg reduced the risk of SH by 69% (relative risk [95% CI] 0.31 [0.13, 0.68]) in MDI-treated pts but did not affect the relatively low rate in those using CSII. Conclusion: These data confirm that SOTA reduced the incidence of SH in pts with T1D, and indicates consistent dose-related risk reduction in almost all subgroups. Disclosure J. Pettus: Consultant; Self; Diasome Pharmaceuticals, Inc., Lexicon Pharmaceuticals, Inc., MannKind Corporation, Novo Nordisk Inc., Sanofi. T. Danne: Advisory Panel; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Medtronic, Novo Nordisk A/S, Sanofi. A.L. Peters: Advisory Panel; Self; Abbott, Bigfoot Biomedical, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, MannKind Corporation, Medscape, Novo Nordisk Inc., Sanofi US. Consultant; Self; Livongo Health. Research Support; Self; Dexcom, Inc., vTv Therapeutics. Other Relationship; Self; Livongo Health, Mellitus Health, Omada Health, Stability Healthcare, Whole Biome Inc. A.K. Carroll: Employee; Self; Lexicon Pharmaceuticals, Inc. Stock/Shareholder; Self; Lexicon Pharmaceuticals, Inc. S. Sawhney: None. W. Jiang: Employee; Self; Lexicon Pharmaceuticals, Inc. Stock/Shareholder; Self; Lexicon Pharmaceuticals, Inc. P.L. Banks: Employee; Self; Lexicon Pharmaceuticals, Inc. J.B. McGill: Advisory Panel; Self; Aegerion Pharmaceuticals, Bayer AG, Lilly Diabetes, Novo Nordisk A/S. Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Dexcom, Inc. Research Support; Self; Medtronic, Novo Nordisk Inc., Sanofi. Speaker’s Bureau; Self; Aegerion Pharmaceuticals, Dexcom, Inc., Janssen Pharmaceuticals, 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 | 0.004 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.004 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.003 | 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".