Treatment With Canagliflozin Versus Placebo in Children and Adolescents With Type 2 Diabetes : A Randomized Clinical Trial
Primary result · HbA1c reduction from baselineResult — go to the resultDifference in least-squares means −0.76 % 95% CI −1.25% to −0.27%Authors' conclusion
In children and adolescents with T2DM, canagliflozin provided a clinically meaningful reduction in HbA1c, with a safety profile similar to that seen in adults.
Study context
- Population
- Children and adolescents aged ≥10 years with T2D (HbA1c ≥6.5% to ≤11%)
- Participants
- 171 children
- Comparison
- Canagliflozin once daily vs placebo
- Canagliflozinn = 84
- Placebon = 87reference
- Primary endpoint
- Change in HbA1c from baseline
- Follow-up
- Week 26
Methodological detailsphase 3, double-blind, placebo-controlled, parallel-group, multicentre (104 sites in 10 countries), re-randomization at week 13 to 100 mg or uptitration to 300 mg (or placebo), Treatment period 52 weeks
- Phase 3
- Double-blind
- Placebo-controlled
- Parallel-group
- Multicentre (104 sites in 10 countries)
- Re-randomization at week 13 to 100 mg or uptitration to 300 mg (or placebo)
- Treatment period 52 weeks
Primary result
HbA1c reduction from baseline
Difference in least-squares means
−0.76 %
95% CI −1.25% to −0.27%
P = 0.002
Canagliflozinvs Placebo
difference in least-squares means −0.76 % (95% CI −1.25% to −0.27%); P = 0.002
As reported in the abstract
Secondary outcomes
| Outcome | Canagliflozin | Placebo | Difference (percentage points) (CI) | |
|---|---|---|---|---|
| HbA1c <6.5% | 36.3% | 14.0% | 22.3 (10.5–34.1) | |
| −2002040Difference, percentage points (linear scale) |
Safety
Treatment-emergent AEs
Serious treatment-emergent AEs
Hypoglycemia
Serious treatment-emergent adverse events (AEs)
- Common AEs with canagliflozin similar to those in adults
Original publication
Treatment With Canagliflozin Versus Placebo in Children and Adolescents With Type 2 Diabetes : A Randomized Clinical Trial. Ann Intern Med. Published 5 August 2025. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →