CONFERENCE UPDATE: EASD 2023

26-week treatment of dapagliflozin exhibits remarkable efficacy and tolerability among children and adolescents with T2D: Analysis of the phase 3 T2NOW study

DIABETES & ENDOCRINOLOGY
29 Dec 2023

STUDY DESIGN

Despite an increasing incidence of type 2 diabetes mellitus (T2D) among children and adolescents, treatment options for this population remain limited.1 The T2NOW study was a 26-week, double-blinded, phase 3 study that investigated the efficacy and safety of dapagliflozin (DAPA) or saxagliptin versus placebo in children and adolescents with T2D.1 The clinical efficacy of DAPA among children and adolescents with T2D was reported in this analysis.1

In this study, T2D patients who were aged 10-17 years, had a hemoglobin A1c (HbA1c) level of 6.5-10.5% and received prior treatment of metformin and/or insulin for ≥8 weeks were randomized to receive a daily dose of DAPA 5mg (n=81) or placebo (n=76).1 The DAPA group was further assessed at Week 14 for their HbA1c levels.1 Patients with a HbA1c level <7% continued receiving dapagliflozin 5mg daily, whereas patients with a HbA1c level ≥7% were randomized to receive dapagliflozin 5mg or 10mg daily.1 After the primary endpoint assessment at week 26, the respective treatment of each group was continued until week 26.1

The primary endpoint of this analysis was the change in HbA1c levels from baseline at week 26.1 Secondary endpoints included safety, achievement rate of HbA1c <7% at week 26 and change in fasting plasma glucose (FPG) from baseline at week 26.1

Primary endpoints: 
  • The primary endpoint was the change in HbA1c at week 261
  • At week 26, patients receiving dapagliflozin (DAPA) had a significant reduction of 0.62% in HbA1c compared with an increase of 0.41% in HbA1c among those receiving placebo (difference=-1.03%; 95% CI: -1.57 to -0.49; p<0.001)1
  • The significant HbA1c improvement associated with DAPA was sustained from week 26 to week 26 across the study period (difference=-1.19%; 95% CI: -1.99 to -0.39; p=0.004)1
  • The HbA1c improvements observed at week 26 were consistently associated with DAPA across the baseline subgroups1
Secondary endpoint:
  • The secondary endpoints included change in fasting plasma glucose (FPG) from baseline at week 26 and the proportion of patients achieving HbA1c <7% at week 261
  • At week 26, the DAPA group exhibited significant improvements in FPG compared to the placebo group (difference=-1.08mmol/L; 95% CI: -2.02 to -0.14; p=0.024)1
  • The improvements in FPG observed in the DAPA group remained significant at week 26 (difference=-2.03mmol/L; 95% CI: -3.51 to -0.56; p=0.007)1
  • The proportion of patients reaching an HbA1c <7% was significantly greater in the DAPA group than in the placebo group (26.6% vs 10%), where patients in the DAPA group were 3.8 times more likely to achieve HbA1c <7% (adjusted OR=3.8; 95% CI: 1.2 to 11.7; p=0.019)1
Safety:
  • Overall, the safety profile of DAPA was consistent with the pre-established safety profile of DAPA in adults, with no new safety signals observed in younger patients1
  • The proportions of patients who experienced ≥ 1 adverse event (AE) were similar between the DAPA and placebo groups (week 26: 54% vs. 62%; week 26: 73% vs. 71%)1
  • The incidence of hypoglycemic events were also comparable between the DAPA and placebo groups (week 26: 25% vs. 26%; week 26: 30% vs. 29%)1

 

“Dapagliflozin achieved the primary endpoint in this phase 3 study, confirming its efficacy and safety in children and adolescents with T2D receiving metformin, insulin, or both”

Dr. Naim Shehadeh
Institute of Diabetes, Endocrinology, and Metabolism,
Rambam Health Care Campus,
Haifa, Israel

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