Trial results for canagliflozin in children and adolescents with Type 2 Diabetes Mellitus were posted on ClinicalTrials.gov on 2025-03-12. The study demonstrated that canagliflozin significantly reduced glycated hemoglobin (HbA1c) compared to placebo. Participants receiving canagliflozin 100/300 mg experienced a least squares mean change of -0.37% in HbA1c, versus a 0.39% increase for placebo, with a statistically significant least square mean difference of -0.76% (p=0.002).
Background
The study investigated canagliflozin for the treatment of Type 2 Diabetes Mellitus in children and adolescents.
Trial design
The Phase 3 study (NCT03170518) was designed to investigate the efficacy and safety of canagliflozin in children and adolescents aged 10 to less than 18 years with Type 2 Diabetes Mellitus. The trial enrolled 171 participants. The primary objective was to assess the effect of canagliflozin relative to placebo on glycated hemoglobin (HbA1c) after 26 weeks of treatment, and to assess the overall safety and tolerability. Participants were randomized to receive either canagliflozin 100 mg, canagliflozin 300 mg, or placebo.
Key results
The trial results showed a significant reduction in glycated hemoglobin (HbA1c) with canagliflozin treatment.
- For the "Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26":
- Participants in the placebo group showed a least squares mean change of 0.39% (Standard Error: 0.191).
- Participants in the canagliflozin 100/300 mg group showed a least squares mean change of -0.37% (Standard Error: 0.194).
An ANCOVA analysis revealed a least square mean difference of -0.76% (95.0% CI: -1.25 to -0.27) between the canagliflozin 100/300 mg group and placebo, with a p-value of 0.002.
- For the "Change From Baseline in Fasting Plasma Glucose (FPG)":
- At Weeks 26 and 52, participants in the placebo group showed a least squares mean change of 15.3 mg/dL (Standard Error: 6.68) and 19.2 mg/dL (Standard Error: 6.90), respectively.
- Participants in the canagliflozin 100/300 mg group showed a least squares mean change of -11.5 mg/dL (Standard Error: 6.86) and -16.4 mg/dL (Standard Error: 6.98) at Weeks 26 and 52, respectively.
- Regarding "Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)":
- Placebo: 74.7%
- Canagliflozin 100 mg: 76.1%
- Canagliflozin 300 mg: 82.4%
What this means
The results of this Phase 3 study indicate that canagliflozin effectively reduced glycated hemoglobin (HbA1c) and fasting plasma glucose (FPG) in children and adolescents with Type 2 Diabetes Mellitus compared to placebo. The statistically significant reduction in HbA1c suggests a potential benefit for glycemic control in this younger population. While the percentage of participants experiencing treatment-emergent adverse events was numerically higher in the canagliflozin 300 mg group compared to placebo, the overall safety profile details are not provided in this summary. These findings support the potential use of canagliflozin as a treatment option for pediatric Type 2 Diabetes Mellitus.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03170518, titled "A Study to Investigate the Efficacy and Safety of Canagliflozin in Children and Adolescents (>=10 to <18 Years) With Type 2 Diabetes Mellitus," were posted on 2025-03-12 on clinicaltrials.gov.