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Treatment With Canagliflozin Versus Placebo in Children and Adolescents With Type 2 Diabetes : A Randomized Clinical
Ulhas Nadgir1, Saberi Rana Ali2, Jagadish Gogate2
1Sutter Medical Group, Sacramento, California (U.N.).
Background:
Treatment options for children and adolescents with type 2 diabetes mellitus (T2DM) are limited. Canagliflozin is a sodium-glucose cotransporter-2 inhibitor approved for the treatment of T2DM in adults.
Objective:
To assess the safety and efficacy of canagliflozin in children and adolescents with T2DM.
Design:
Phase 3, randomized, double-blind, placebo-controlled, parallel-group study. (ClinicalTrials.gov: NCT03170518; EudraCT: 2016-005223-88).
Setting:
Multicenter (104 sites in 10 countries).
Participants:
Children and adolescents aged 10 years or older with T2DM (hemoglobin A1c [HbA1c] ≥6.5% to ≤11%).
Intervention:
Participants were randomly assigned to canagliflozin (100 mg) or placebo once daily. Participants with week 12 readings of 7% or higher for HbA1c and at least 60 mL/min/1.73 m2 for estimated glomerular filtration rate were randomly assigned again at week 13 to either keep receiving 100 mg of canagliflozin (or placebo) or have their dose uptitrated to 300 mg (or placebo). The treatment period was 52 weeks.
Measurements:
Change in HbA1c from baseline to week 26 (primary efficacy end point), secondary efficacy end points, and safety.
Results:
A total of 171 participants were randomly assigned to canagliflozin (n = 84) or placebo (n = 87). At week 26, HbA1c reduction from baseline was significantly greater with canagliflozin than placebo (difference in least-squares means, -0.76% [95% CI, -1.25% to -0.27%]; P = 0.002). The proportion of participants who achieved HbA1c levels below 6.5% was significantly greater with canagliflozin than placebo (36.3% vs. 14.0%; difference, 22.3 percentage points [CI, 10.5 to 34.1 percentage points]). Treatment-emergent adverse events (AEs) occurred in 77.4% and 74.7% and serious treatment-emergent AEs in 9.5% and 5.7% of participants who received canagliflozin and placebo, respectively. Common AEs seen with canagliflozin were similar to those in the adult population. Hypoglycemia occurred in 11.9% and 10.3% of participants receiving canagliflozin and placebo, respectively.
Limitation:
Study duration and relatively small sample size.
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.
Primary Funding Source:
Johnson & Johnson.
Insights
Canagliflozin effectively reduced hemoglobin A1c in pediatric patients with type 2 diabetes mellitus. The safety profile was comparable to adults, offering a new treatment option for this population.
Area of Science:
- Endocrinology
- Pediatric Diabetes Management
- Pharmacology
Background:
- Limited treatment options exist for pediatric type 2 diabetes mellitus (T2DM).
- Canagliflozin, a sodium-glucose cotransporter-2 inhibitor, is approved for adult T2DM treatment.
Purpose of the Study:
- To evaluate the safety and efficacy of canagliflozin in children and adolescents with T2DM.
Main Methods:
- Phase 3, randomized, double-blind, placebo-controlled study involving 171 participants aged 10+ with T2DM.
- Participants received either canagliflozin (100 mg or 300 mg) or placebo daily for 52 weeks.
- Primary endpoint was change in hemoglobin A1c (HbA1c) from baseline to week 26.
Main Results:
- Canagliflozin significantly reduced HbA1c compared to placebo at week 26 (mean difference -0.76%, P=0.002).
- A greater proportion of participants on canagliflozin achieved HbA1c <6.5% (36.3% vs. 14.0%).
- Adverse events were similar between groups; hypoglycemia occurred in 11.9% (canagliflozin) and 10.3% (placebo).
Conclusions:
- Canagliflozin offers a clinically meaningful HbA1c reduction in pediatric T2DM patients.
- The safety profile in adolescents is consistent with that observed in adult populations.
- Canagliflozin represents a promising therapeutic option for managing T2DM in children and adolescents.
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