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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