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Canagliflozin may significantly improve glycemic control in children and adolescents with type 2 diabetes
1. In this randomized controlled trial involving children and adolescents with type 2 diabetes mellitus, canagliflozin was associated with significantly greater improvement in HbA1c levels and fasting blood glucose compared to placebo.
2. Treatment-emergent adverse events were common in both groups, but less than one-tenth of participants had serious adverse events.
Evidence Rating Level: 1 (Excellent)
Study Rundown: The incidence of type 2 diabetes mellitus (T2DM) in children has increased dramatically, but treatment options in this population remain limited. Canagliflozin has been shown to significantly improve glycemic control and cardiovascular outcomes in adults with T2DM, but its safety and efficacy in children and adolescents remain unclear. This study aimed to assess the effects of canagliflozin in children and adolescents with inadequately controlled T2DM. After approximately six months of follow-up, canagliflozin was found to be associated with significantly greater improvement in HbA1c levels compared with placebo, including among participants who had already been given metformin with or without insulin. Participants who received canagliflozin were significantly more likely to have achieved an HbA1c level less than 6.5% or less than 7.0% at both six months and one year compared with participants receiving placebo. Canagliflozin was also associated with a significantly greater change in fasting blood glucose from baseline as well as a significantly greater reduction in body weight percentage. Fewer participants receiving canagliflozin required rescue medicine compared with participants receiving placebo. Nearly three-quarters of participants in both groups reported treatment-emergent events, which generally mirrored the types of events seen in the adult population. The generalizability of this study is limited by its relatively short treatment period, small sample size, and potential unmeasured confounding. Nevertheless, these results suggest that canagliflozin may be safe and effective in reducing HbA1c among children and adolescents with T2DM.
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In-Depth [randomized controlled trial]: This randomized controlled trial aimed to assess the safety and efficacy of canagliflozin in children and adolescents with T2DM. Participants were eligible if they were aged between 10 and 18 years and had been given a diet and exercise regimen either alone for at least 4 weeks or alongside metformin monotherapy, insulin monotherapy, or a combination of metformin and insulin for at least 8 weeks. The primary outcome was change in HbA1c after 26 weeks of treatment. Secondary endpoints included the change in HbA1c after 52 weeks of treatment, change in fasting plasma glucose and body weight after 26 and 52 weeks of treatment, and proportions of participants who achieved HbA1c below 6.5%, 7.0%, and 7.5% after 26 and 52 weeks, among others. The study included 171 participants, 84 of whom were randomly assigned to receive canagliflozin. At week 26, participants in the canagliflozin group had a significantly greater reduction in HbA1c levels compared with placebo (difference in least-squares [LS] means, -0.76% [95% CI, -1.25% to -0.27%]; p = 0.002); similar results were seen among participants who already received metformin with or without insulin (difference in LS means, -0.77% [95% CI, -1.38% to -0.17%]; p = 0.012). A sensitivity analysis showed that significant improvement in HbA1c could be seen as early as week 6 and was maintained through the end of study treatment both in the overall population and among participants receiving background metformin with or without insulin. Subgroup analysis showed that the effects of canagliflozin were more pronounced in girls (difference in LS means, -0.90% [95% CI, -1.50% to -0.30%]) and in participants aged 15 to 17 years (difference in LS means, -1.05% [95% CI, -1.74% to -0.36%]). Those who received canagliflozin also had a significantly greater percentage change in body weight (difference in LS means, -1.6 percentage point [95% CI, -2.9 to -0.3 percentage point]). Treatment-emergent AEs were reported in 65 (77.4%) canagliflozin participants and 65 (74.7%) placebo participants. Canagliflozin participants were more likely than placebo participants to suffer from headaches (10.7% vs. 3.4%), nasopharyngitis (9.5% vs. 5.7%), urinary tract infections (7.1% vs. 4.6%), and vomiting (6.0% vs. 2.3%). Serious AEs were reported in 8 (9.5%) canagliflozin participants and 5 (5.7%) placebo participants. Symptomatic hypoglycemia was reported in 10 participants (11.9%) who received canagliflozin and 9 (10.3%) who received placebo. Overall, this study suggests that canagliflozin may be a safe and effective tool for improving glycemic control in children and adolescents with T2DM.
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