Key takeaways:
- Sotagliflozin improved HbA1c and physique weight for sufferers with sort 2 diabetes.
- The remedy impact various by kidney perform; sufferers with worse kidney perform had diminished profit vs. placebo.
ORLANDO — In sufferers with sort 2 diabetes, sotagliflozin improved HbA1c and physique weight in contrast with placebo, although the remedy impact various by kidney perform, in response to a meta-analysis.
As well as, amongst sufferers with impaired kidney perform, sotagliflozin (Inpefa, Lexicon) 400 mg carried out higher vs. placebo than sotagliflozin 200 mg, in response to the researchers.
Belinda Hardin, PharmD, senior director of medical communications and head of discipline medical at Lexicon Prescribed drugs, introduced outcomes of a patient-level meta-analysis of eight trials evaluating sotagliflozin with placebo in sufferers with sort 2 diabetes on the American Affiliation of Medical Endocrinology Annual Scientific and Medical Convention.
“As many as 40% of sufferers with diabetes will develop some sort of kidney impairment,” Hardin mentioned throughout a presentation. “Sotagliflozin is an inhibitor of each SGLT1 and SGLT2 and has been proven to scale back coronary heart failure-related outcomes, particularly within the SCORED research of sufferers with reasonably impaired renal perform. Nonetheless, this research didn’t look particularly at HbA1c. It led us to ask the query … whether or not it will result in a discount in HbA1c as seen with different SGLT2 inhibitors.”
The three,896 sufferers (imply age, 63.1 years; 45.5% girls; 60.7% with weight problems) had been stratified into tertiles by estimated glomerular filtration price: 60 mL/min/1.73 m2 or extra; 30 mL/min/1.73 m2 to lower than 60 mL/min/1.73 m2; or lower than 30 mL/min/1.73 m2. The first outcomes had been placebo-adjusted least-squares imply adjustments in HbA1c and physique weight.
For each outcomes, the best remedy impact of sotagliflozin was in sufferers with eGFR 60 mL/min/1.73 m2 or extra, and there was no distinction between the 200 mg and 400 mg sotagliflozin doses in that group, in response to the researchers.
For sufferers with eGFR 30 mL/min/1.73 m2 to lower than 60 mL/min/1.73 m2, “400 mg of sotagliflozin nonetheless maintains efficacy for each HbA1c and physique weight,” Hardin mentioned. “The 200 mg dose has a reasonably slim confidence interval however does cross the road of unity for HbA1c.”
For sufferers with eGFR lower than 30 mL/min/1.73 m2, “we begin to see a discount within the capabilities to take care of discount in each HbA1c and physique weight, with a reasonably large confidence interval,” Hardin mentioned. “Aside from physique weight within the 400 mg dose, all of those cross the road of unity, with [HbA1c] within the 200 mg really favoring placebo.”
A earlier meta-analysis confirmed that sotagliflozin maintained reductions in systolic blood stress vs. placebo no matter kidney perform, however this meta-analysis was completely different, Hardin mentioned throughout the presentation.
“Each 200 mg and 400 mg [sotagliflozin] do considerably enhance glycemic management as decided by HbA1c and considerably enhance physique weight in comparison with placebo,” she mentioned. “Nonetheless, 400 mg really gives the best enchancment within the presence of reasonable to extreme renal impairment. Though there are advantages, that diploma of enchancment is, in actual fact, attenuated in these sufferers, particularly these with the most-reduced kidney perform. This is a vital discovering [which will] assist inform medical decision-making.”
Sources/Disclosures
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Hardin B, et al. Evaluating sotagliflozin results on HbA1c and physique weight throughout levels of diabetic kidney illness. Introduced at: American Affiliation of Medical Endocrinology Annual Scientific and Medical Convention; Could 15-17, 2025; Orlando.
Disclosures:
The research had been funded by Lexicon Prescribed drugs. Hardin experiences being an worker of and holding fairness in Lexicon Prescribed drugs.
