Led by Caroline K. Kramer of the Leadership Sinai Centre for Diabetes at Mount Sinai Hospital, Toronto, the trial addressed an important question: can early pharmacological intervention protect women with prior gestational diabetes mellitus (GDM) from progressing to type 2 diabetes? Women with a history of GDM are known to face a heightened risk of beta-cell decline and subsequent dysglycemia, yet few clinical trials have tested strategies to slow this process.
The double-blind study enrolled 91 participants between 6 and 36 months after childbirth. All had experienced GDM during pregnancy. They were randomly assigned to receive either 10 mg of the sodium–glucose cotransporter-2 (SGLT-2) inhibitor empagliflozin or a placebo once daily for 48 weeks. Investigators used the Insulin Secretion-Sensitivity Index-2 (ISSI-2) derived from an oral glucose tolerance test to evaluate beta-cell function. Additional measures included the insulinogenic index/HOMA-IR and ΔC-peptide/Δglucose multiplied by the Matsuda index.
The study revealed the following findings:
- After nearly a year of treatment, there was no significant difference in beta-cell function between the empagliflozin and placebo groups.
- Baseline-adjusted ISSI-2 scores were 525 for the empagliflozin group and 560 for the placebo group, a nonsignificant difference.
- Other indicators of beta-cell activity and insulin secretion showed similar results, confirming no meaningful preservation of beta-cell capacity with empagliflozin.
- Rates of dysglycemia were comparable, affecting 65.7% of the empagliflozin group and 48.2% of the placebo group.
- Only 9.4% of women on empagliflozin experienced worsening glucose tolerance compared with 28% in the placebo group, a trend approaching statistical significance.
The researchers pointed out that the relatively small sample size limited the trial’s power to detect subtle effects. They also emphasized that although the main beta-cell endpoint was negative, the data hinted at potential benefits in insulin sensitivity and fasting glucose trajectories among those taking empagliflozin.
"Given the persistent risk of type 2 diabetes in women with prior gestational diabetes, the findings underscore the importance of continued investigation. Larger, longer trials are needed to clarify whether SGLT-2 inhibitors like empagliflozin can play a preventive role in this high-risk population," the authors wrote.
"While empagliflozin did not demonstrate a protective effect on beta-cell function over 48 weeks, its favorable influence on glucose trends suggests it may warrant further evaluation as part of a broader strategy to reduce diabetes risk after gestational diabetes," they concluded.
Reference: https://doi.org/10.1111/dom.70146
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