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    Home > Active Ingredient News > Endocrine System > LANCET sub-journal: What is the efficacy and safety of dapagliflozin for children with diabetes?

    LANCET sub-journal: What is the efficacy and safety of dapagliflozin for children with diabetes?

    • Last Update: 2022-06-12
    • Source: Internet
    • Author: User
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    Compiled and organized by Yimaitong, please do not reprint without authorization
    .

    Recently, the journal The lancet Diabetes & endocrinology published a study of young adults with type 2 diabetes treated with metformin, insulin (or both) (subjects aged 10-24 years, mean age about 16 years old).
    ) to evaluate the efficacy and safety of dapagliflozin as an add-on treatment
    .

    Study Design This was a multicenter, placebo-controlled, double-blind, randomized phase 3 study conducted at 30 centers in five countries (Hungary, Israel, Mexico, Russia, and the United States)
    .

     The double-blind period lasted for 24 weeks, and subjects aged 10-24 years, with type 2 diabetes and HbA1c level of 6.
    5%-11% were randomly assigned to the oral dapagliflozin 10 mg group or the placebo group in a 1:1 ratio; A 28-week open-label safety extension followed, with all subjects receiving dapagliflozin
    .

     The primary study endpoint was the between-group difference in change in HbA1c levels from baseline to 24 weeks (intention-to-treat analysis)
    .

     Table 1 Results of the Subject Characteristics Study Between June 22, 2016, and March 15, 2019, 72 participants (19 of whom were aged 18-24 years) were randomized (n=39 in the dapagliflozin group) , placebo group n=33), mean age 16.
    1 years
    .

     1.
    Hypoglycemic efficacy In the intention-to-treat analysis, after 24 weeks, the mean change from baseline in HbA1c concentration in the dapagliflozin group was -0.
    25%, compared with 0.
    50% in the placebo group, and the difference between the groups was -0.
    75% (p=0·10)
    .

     In a sensitivity analysis of the eligible population (34 in the dapagliflozin group and 26 in the placebo group) after 24 weeks, the mean change from baseline in HbA1c was -0.
    51% in the dapagliflozin group and -0.
    51% in the placebo group.
    This figure was 0.
    62% in the drug group, and the difference between the groups was -1.
    13% (P=0.
    012)
    .

     2.
    Safety No serious adverse events and no events of diabetic ketoacidosis occurred
    .

     STUDY SUMMARY In an intention-to-treat analysis, the addition of dapagliflozin to standard of care, the change from baseline in HbA1c levels was not significantly different between the dapagliflozin group and the placebo group
    .

    A prespecified sensitivity analysis of eligible participants revealed that changes in HbA1c levels differed significantly between groups
    .

    No new safety signals were identified and the risk of severe hypoglycemia was low
    .

     Yimaitong compiled and compiled from: Tamborlane WV, Laffel LM, Shehadeh N, et al.
    Efficacy and safety of dapagliflozin in children and young adults with type 2 diabetes: a prospective, multicentre, randomised, parallel group, phase 3 study[J] .
    The lancet Diabetes & endocrinology.
    2022 Apr 1.
    DOI: 10.
    1016/S2213-8587(22)00052-3, PMID:35378069
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