Empagliflozin for the preservation of beta-cell function in women with recent gestational diabetes: A randomized placebo-controlled trial
Abstract
AIMS: Women with a history of gestational diabetes (GDM) frequently have progressive beta-cell dysfunction, which may result in type 2 diabetes. However, there is a paucity of clinical studies on strategies aiming to preserve beta-cell function in this patient population. This trial evaluated whether empagliflozin can preserve beta-cell function and reduce the prevalence of dysglycemia (prediabetes/diabetes) in women with recent GDM.
MATERIALS AND METHODS: We conducted a double-blind, randomized, placebo-controlled trial where 91 women with recent GDM (6-36 months postpartum) were randomized 1:1 to either empagliflozin 10 mg/day or placebo for 48 weeks. Beta-cell function was assessed by Insulin Secretion-Sensitivity Index-2 (ISSI-2) obtained on an oral glucose tolerance test.
RESULTS: The primary outcome of baseline-adjusted ISSI-2 at 48 weeks was not different between the empagliflozin and placebo group (525 ± 30.4 vs. 560 ± 33.4, p = 0.43). Additional measures of beta-cell function, insulinogenic index/HOMA-IR, and ΔCpep0-120/Δgluc0-120 × Matsuda index also did not differ between the groups. While there was no difference in the secondary outcome of prevalence of dysglycemia at 48 weeks between the arms (empagliflozin 65.7% vs. 48.2% in placebo, p = 0.18), the glucose tolerance worsened in 9.4% of participants in the empagliflozin group as compared to 28% in the placebo group (p = 0.08).
CONCLUSIONS: Empagliflozin had no significant effect on beta-cell function in women…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 91 participants or records.
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