NCT03170518

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

A Randomized, Multicenter, Double-Blind, Parallel-Group, Placebo-Controlled Study to Investigate the Efficacy and Safety of Canagliflozin in Children and Adolescents (≥10 to <18 Years) With Type 2 Diabetes Mellitus

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 171 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 10 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	Canagliflozin 100 mg	Canagliflozin 100 mg tablet will be administered orally (by mouth) once-daily.
DRUG	Canagliflozin 300 mg	Canagliflozin 300 mg tablet will be administered orally once-daily.
DRUG	Placebo	Matching placebo tablet will be administered orally once-daily.

Timeline

• Start date: 2017-07-21
• Primary completion: 2023-09-20
• Completion: 2023-09-20
• First posted: 2017-05-31
• Last updated: 2025-04-25
• Results posted: 2025-03-12

Locations

106 sites across 10 countries: United States, Brazil, China, Greece, India, Malaysia, Mexico, Philippines, Poland, Russia

Regulatory

• FDA-regulated drug study