A Study to Investigate the Efficacy and Safety of Canagliflozin in Children and Adolescents (>=10 to <18 Years) With Type 2 Diabetes Mellitus

Phase 3 Completed 171 enrolled Janssen Research & Development, LLC

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is 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 of canagliflozin.

Timeline

Start: 2017-07-21
Primary completion: 2023-09-20
Completion: 2023-09-20

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo vs Canagliflozin 100/300 mg; p = 0.002; Least square mean difference -0.76 (95% CI -1.25 to -0.27); ANCOVA NCT03170518 ↗

Publications

Nadgir U, Ali SR, Gogate J, Shaw W, Antunes J, Fonseca S. Treatment With Canagliflozin Versus Placebo in Children and Adolescents With Type 2 Diabetes : A Randomized Clinical Trial. Ann Intern Med. 2025 Sep;178(9):1217-1226. doi: 10.7326/ANNALS-24-04017. Epub 2025 Aug 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	CANAGLIFLOZIN ANHYDROUS	Small molecule	100 mg	Oral
Subject	CANAGLIFLOZIN ANHYDROUS	Small molecule	300 mg	Oral