TUESDAY, March 21, 2023 (HealthDay News) -- For young people, empagliflozin is associated with improvement in glycated hemoglobin (HbA1c), according to a study published in the March issue of The Lancet Diabetes & Endocrinology.
Lori M. Laffel, M.D., from Harvard Medical School in Boston, and colleagues conducted a placebo-controlled trial in 108 centers in 15 countries involving participants with type 2 diabetes (aged 10 to 17 years) previously treated with metformin or insulin. During April 26, 2018, through May 26, 2022, participants were randomly assigned to oral empagliflozin 10 mg, oral linagliptin 5 mg, or placebo (52, 53, and 53 participants, respectively). Those in the empagliflozin group who did not have HbA1c <7.0 percent by week 12 were reassigned (randomly) to remain on 10 mg or increase to 25 mg empagliflozin. Those in the placebo group were reassigned (randomly) to linagliptin 5 mg or 10 or 25 mg empagliflozin at week 26. The trial was double-blinded; investigators were masked at the initial randomization and rerandomization periods.
The researchers found that for the primary outcome, the adjusted mean change from baseline in HbA1c at week 26 was −0.84 percent for empagliflozin versus placebo and −0.34 percent for linagliptin versus placebo. Up to week 26, adverse events occurred in 64, 77, and 71 percent of participants in the placebo, empagliflozin, and linagliptin groups, respectively.
"Given the recognized challenges of treating type 2 diabetes in young people, and the likely need for combination pharmacotherapy to achieve target glycemic control aimed at preventing complications and preserving health, oral administration of empagliflozin along with injectable insulin might offer a promising approach to care," Laffel said in a statement.
Several authors disclosed financial ties to pharmaceutical companies, including the Boehringer Ingelheim and Eli Lilly and Company Alliance, which manufactures empagliflozin and funded the study.
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