CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 171 enrolled
Drug / intervention
Canagliflozin 100 mg +2 moredrug
Likely dose
Canagliflozin 100 mg or 300 mg orally once dailyAI-extracted
Key inclusion· 4
  • ✓Confirmed type 2 diabetes mellitus diagnosis
  • ✓C-peptide >0.6 ng/mL (>0.2 nmol/L) at screening to confirm endogenous insulin secretion
  • ✓HbA1c 6.5-11%
  • ✓On diet and exercise only for ≥4 weeks prior to screening, OR on stable metformin ≥1000 mg daily for ≥8 weeks, OR on stable insulin monotherapy for ≥8 weeks, OR on stable metformin-insulin combination for ≥8 weeks
Key exclusion· 6
  • ✕History of diabetic ketoacidosis (DKA), type 1 diabetes, pancreas or cell transplantation, or secondary diabetes from pancreatitis/pancreatectomy or MODY
  • ✕Use of any antihyperglycemic agents other than metformin or injectable insulin within 8 weeks of Day 1
  • ✕Repeated fasting blood glucose >270 mg/dL (>15 mmol/L) on ≥2 measurements during 1-week period in pretreatment phase despite diet/exercise counseling
  • ✕Severe hypoglycemia within 6 months prior to Day 1

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03170518
NCT03170518Phase 3Completed
CompareCT.gov

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

Janssen Research & Development, LLC·interventional·Posted May 31, 2017·Updated Apr 25, 2025

In Brief

A Phase 3 clinical trial evaluating Canagliflozin 100 mg, Canagliflozin 300 mg, and 1 other intervention for Diabetes Mellitus, Type 2. Completed, enrolled 171 participants across 106 sites in 10 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesBrazil, China, Greece, India, Malaysia, Mexico, Philippines, Poland, Russia, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedMay 31, 2017
Enrollment StartJul 21, 2017
Primary CompletionSep 20, 2023
TodayJul 2, 2026
Enrollment to primary: 6.2 yearsPosted 9.1 years ago

Interventions

Canagliflozin 100 mgdrug

Canagliflozin 100 mg tablet will be administered orally (by mouth) once-daily.

Canagliflozin 300 mgdrug

Canagliflozin 300 mg tablet will be administered orally once-daily.

Placebodrug

Matching placebo tablet will be administered orally once-daily.