Effect of Sotagliflozin on eGFR Slope by Baseline Kidney Function and Glycemic Control
Bibliographic record
Abstract
Background: In a secondary analysis of the SCORED trial using the complete laboratory dataset, sotagliflozin (SOTA), a dual SGLT1 & 2 inhibitor, reduced the risk of kidney and cardiorenal composite endpoints in patients with type 2 diabetes (T2D) and diabetic kidney disease (DKD). This post hoc analysis of SCORED evaluated the effect of SOTA versus placebo on eGFR slope and the impact of baseline kidney function and glycemia. Methods: We derived the acute eGFR slope (from baseline to week 4), chronic slope (week 4 to month 12) and total slope using a spline mixed effects repeated measures model on the entire cohort and in the following baseline subgroups – eGFR <30, 30 to <45, ≥45 ml/min/1.73m2; A1, A2 and A3 albuminuria; glycated hemoglobin A1C <8%, ≥8 to <9%, ≥9%. Results: Within the entire cohort of 10,574 participants, a placebo-adjusted acute decline in eGFR of -2.59 ml/min/1.73m2/year (95% CI -2.88, -2.30; p<0.0001) was observed. The chronic slope, measured after this acute decline, was 1.99 ml/min/1.73m2/year in favor of SOTA (95% CI 1.63, 2.34; p<0.0001). The total placebo-adjusted slope was -0.08 ml/min/1.73m2/year (95% CI -0.43, 0.27; p=0.67). The magnitude of the acute decline attenuated across progressively lower eGFR subgroups (P-interaction =0.017). Effects on chronic slope were consistent across baseline eGFR and A1C subgroups (P-interaction=0.48 and 0.22). Compared to placebo, SOTA had a greater benefit on chronic slope with increasing baseline albuminuria (P-interaction=0.023) Conclusion: In participants with DKD, treatment with SOTA conferred kidney protection across a spectrum of baseline kidney function and glycemic control. The magnitude of kidney protection was larger with increasing albuminuria. Funding: Commercial Support - Lexicon Pharmaceuticals
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 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 teacher head, 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".