Kidney Effects of Empagliflozin in People with Type 1 Diabetes
Bibliographic record
Abstract
Background: Empagliflozin lowers the risk of cardiovascular and kidney events in type 2 diabetes (T2D). In the empagliflozin in type 1 diabetes (T1D) clinical program (EASE), glycemic control, weight and blood pressure improved with empagliflozin as adjunct to insulin treatment, though diabetic ketoacidosis risk was higher with use of the 10 and 25mg doses vs the 2.5mg dose. The kidney effects of empagliflozin in T1D remain incompletely understood. Methods: Here we report changes in kidney parameters in phase 3 placebo-controlled trials EASE-2 (empagliflozin 10/25mg; 52-week; n=730) and EASE-3 (empagliflozin 2.5/10/25mg; 26-week; n=975). Results: Mean±SD baseline estimated glomerular filtration rate (eGFR in mL/min/1.73 m2) in EASE-2/EASE-3 was 97.3±18.2 and 98.5±18.2 and median (interquartile range) baseline urinary albumin-to-creatinine ratio (UACR in mg/g of creatinine) was 6.2 (2.7,14.1) in both studies. After 26 weeks of treatment in EASE-3, mean placebocorrected eGFR changes with empagliflozin 2.5mg (n=230), 10mg (n=228) and 25mg (n=234) were -0.14 (p=0.87), -2.57 (p=0.004) and -3.56 (p<0.0001), respectively. Mean placebo-corrected eGFR changes with empagliflozin 10mg and 25mg were -2.09 (p=0.02; n=226) and -2.60 (p=0.002; n=228) after 52 weeks in EASE-2, respectively. Changes in eGFR 3 weeks after end of therapy (FU) returned to above baseline levels. In participants with UACR <30mg/g, no significant changes in urinary albumin-tocreatinine ratio (UACR) were observed. In a pooled analysis (EASE-2 + EASE-3), in participants with baseline UACR ≥30 mg/g, UACR decreased by 16% (p=0.27) and 30% (p=0.02) with empagliflozin 10mg (n=71) and 25mg (n=77) vs placebo (n=65), respectively, at 26 weeks. In EASE-3, in people with baseline UACR ≥30 mg/g, treatment with empagliflozin 2.5mg (n=36) for 26 weeks did not significantly attenuate UACR vs placebo (n=34). Hematocrit and serum albumin increased in EASE-2 and EASE-3 with empagliflozin treatment while serum uric acid decreased; changes in these parameters returned to near baseline values at the FU visit after 26 and 52 weeks of treatment. Conclusions: In conclusion, empagliflozin doses >2.5 mg/day as adjunct therapy to insulin in T1D resulted in short-term changes in kidney markers comparable to changes observed with SGLT2 inhibitor use in T2D. Funding: Commercial Support - Boehringer Ingelheim & Eli Lilly and Company Diabetes Alliance
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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 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| 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".