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Key clinical point: Dapagliflozin in addition to standard-of-care treatment demonstrated a clinically relevant decrease in glycated hemoglobin (HbA1c) and an acceptable safety profile in young people with type 2 diabetes (T2D).
Major finding: At 24 weeks, the adjusted mean change in HbA1c was not significantly different between the dapagliflozin and placebo groups in the intention-to-treat analysis (between-group difference [Δ] −0.75%; P = .10), but was significantly different in the sensitivity analysis in the per-protocol population (Δ −1.13%; P = .012). No new safety signals or episodes of death or diabetic ketoacidosis were recorded.
Study details: The data come from a phase 3 trial including 72 participants aged 10-24 years with T2D and HbA1c concentration of 6.5%-11% who were randomly assigned to receive oral dapagliflozin (10 mg) or placebo in addition to standard-of-care treatment for 24 weeks followed by dapagliflozin for 28 weeks
Disclosures: The study was funded by AstraZeneca. Some authors declared receiving consulting fees or research grants or serving on advisory boards for various sources, including AstraZeneca. Three authors declared being stockholders or employees of AstraZeneca.
Source: Tamborlane WV, Laffel LM 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. Lancet Diabetes Endocrinol. 2022 (Apr 1). Doi: 10.1016/S2213-8587(22)00052-3
Key clinical point: Dapagliflozin in addition to standard-of-care treatment demonstrated a clinically relevant decrease in glycated hemoglobin (HbA1c) and an acceptable safety profile in young people with type 2 diabetes (T2D).
Major finding: At 24 weeks, the adjusted mean change in HbA1c was not significantly different between the dapagliflozin and placebo groups in the intention-to-treat analysis (between-group difference [Δ] −0.75%; P = .10), but was significantly different in the sensitivity analysis in the per-protocol population (Δ −1.13%; P = .012). No new safety signals or episodes of death or diabetic ketoacidosis were recorded.
Study details: The data come from a phase 3 trial including 72 participants aged 10-24 years with T2D and HbA1c concentration of 6.5%-11% who were randomly assigned to receive oral dapagliflozin (10 mg) or placebo in addition to standard-of-care treatment for 24 weeks followed by dapagliflozin for 28 weeks
Disclosures: The study was funded by AstraZeneca. Some authors declared receiving consulting fees or research grants or serving on advisory boards for various sources, including AstraZeneca. Three authors declared being stockholders or employees of AstraZeneca.
Source: Tamborlane WV, Laffel LM 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. Lancet Diabetes Endocrinol. 2022 (Apr 1). Doi: 10.1016/S2213-8587(22)00052-3
Key clinical point: Dapagliflozin in addition to standard-of-care treatment demonstrated a clinically relevant decrease in glycated hemoglobin (HbA1c) and an acceptable safety profile in young people with type 2 diabetes (T2D).
Major finding: At 24 weeks, the adjusted mean change in HbA1c was not significantly different between the dapagliflozin and placebo groups in the intention-to-treat analysis (between-group difference [Δ] −0.75%; P = .10), but was significantly different in the sensitivity analysis in the per-protocol population (Δ −1.13%; P = .012). No new safety signals or episodes of death or diabetic ketoacidosis were recorded.
Study details: The data come from a phase 3 trial including 72 participants aged 10-24 years with T2D and HbA1c concentration of 6.5%-11% who were randomly assigned to receive oral dapagliflozin (10 mg) or placebo in addition to standard-of-care treatment for 24 weeks followed by dapagliflozin for 28 weeks
Disclosures: The study was funded by AstraZeneca. Some authors declared receiving consulting fees or research grants or serving on advisory boards for various sources, including AstraZeneca. Three authors declared being stockholders or employees of AstraZeneca.
Source: Tamborlane WV, Laffel LM 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. Lancet Diabetes Endocrinol. 2022 (Apr 1). Doi: 10.1016/S2213-8587(22)00052-3