Effects of Sotagliflozin on Anemia in Patients with Type 2 Diabetes (T2D) and Stages 3 and 4 CKD
Bibliographic record
Abstract
Background: Anemia is frequent in advanced diabetic kidney disease. Sodiumglucose cotransporter inhibitors (SGLTi) consistently increase hemoglobin (Hb) through multiple mechanisms. We examined the effects of sotagliflozin, a dual SGLT1 and SGLT2 inhibitor, on Hb in patients with type 2 diabetes (T2D) and chronic kidney disease (CKD) stage 3 and 4, with and without anemia. Methods: This was a pooled patient-level data analysis from two studies evaluating the efficacy and safety of sotagliflozin (200 and 400 mg) vs. placebo in patients with T2D and CKD 3 or 4 over 26 weeks. The effect of sotagliflozin on Hb, hematocrit, serum albumin, systolic blood pressure (SBP), body weight and estimated glomerular filtration rate (eGFR) was assessed in patients with anemia (defined as baseline Hb <13 mg/dL for men and <12 mg/dL for women) and without anemia. Results: In the entire cohort, baseline mean Hb was 12.7 g/dL and sotagliflozin increased Hb from baseline to week 26 by 0.39 g/dL (200 mg; 95% CI 0.21-0.56) and 0.41 g/dL (400 mg; 95% CI 0.24-0.59) vs. placebo (p<0.0001). Of the 1064 patients randomized, 493 (46.3%) patients had anemia at baseline. The effect on Hb with sotagliflozin relative to placebo was more pronounced in patients without anemia over 26 weeks (Figure [doses pooled]). Sotagliflozin (doses pooled) increased odds of anemia resolving (odds ratio 1.95, p=0.017), with a trend towards decreased odds of anemia developing (odds ratio 0.75, p=0.41) over 26 weeks. The effect of sotagliflozin on serum albumin, SBP, body weight, and eGFR was generally consistent between patients with and without anemia. Sotagliflozin was generally well tolerated with similar safety profiles between anemia subgroups. Conclusions: Sotagliflozin increased Hb in a rapid and sustained manner in patients with T2D and moderate-severe CKD over 26 weeks, and reversed anemia in a population at high risk of anemia. Funding: Commercial Support - Lexicon Pharmaceuticals, Inc., The Woodlands, TXFigure.: Mean change in hemoglobin from baseline over 26 weeks by anemia subgroup
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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 | 0.004 | 0.004 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.004 |
| Bibliometrics | 0.000 | 0.000 |
| 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) | 0.001 | 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".