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

Recruiting in Palo Alto (17 mi)

+122 other locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Janssen Research & Development, LLC

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing canagliflozin, a drug that lowers blood sugar, in people with high blood sugar levels. It aims to see how well it works and if it is safe to use over several months.

Research Team

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Eligibility Criteria

Inclusion Criteria

Participants with a diagnosis of type 2 diabetes mellitus (T2DM)

Random C-peptide at screening greater than (>)0.6 nanogram/milliliter (ng/mL) (>0.2 nanomole/liter [nmol]/L])

HbA1c of greater than or equal to (>=)6.5 percent (%) to less than or equal to (<=)11.0% and meets 1 of the inclusion criteria below:

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Exclusion Criteria

Participants on any antihyperglycemic agents (AHAs) other than metformin, or injectable insulin within 8 weeks of the first dose of study drug (that is Day 1)

Repeated (2 or more over a 1-week period) fasting self-monitoring of blood glucose (SMBG) measurements >270 milligram/deciliter (mg/dL) (>15 millimole/liter [mmol/L]) during the pretreatment phase, despite reinforcement of diet and exercise counseling

Severe hypoglycemia within 6 months prior to Day 1

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Treatment Details

Interventions

Canagliflozin 100 mg (Sodium-glucose cotransporter 2 (SGLT2) inhibitor)
Canagliflozin 300 mg (Sodium-glucose cotransporter 2 (SGLT2) inhibitor)
Placebo (Drug)

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Single-blind run-in Period: PlaceboExperimental Treatment1 Intervention

Participants will receive 1 placebo tablet matching canagliflozin 100 milligram (mg) once-daily during the 2-week single-blind placebo run-in period.

Group II: Double-blind Treatment Phase: Canagliflozin or PlaceboExperimental Treatment3 Interventions

Canagliflozin 100 mg/matching placebo once-daily during first 12 weeks. At Week 13, participants who have glycated hemoglobin (HbA1c) of greater than or equal to (\>=)7.0 percent (%), estimated glomerular filtration rate (eGFR) \>=60 milliliter/minute/1.73 meter square (mL/min/1.73 m\^2) will be re-randomized to either remain on canagliflozin 100 mg/matching placebo or up-titrate to canagliflozin 300 mg/matching placebo till Week 52.