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Sodium-glucose cotransporter 2 (SGLT2) inhibitor

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

Waitlist Available

Research Sponsored by Janssen Research & Development, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (day 1), week 26 and week 52

Awards & highlights

Pivotal Trial

Summary

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.

Eligible Conditions

Type 2 Diabetes
Diabetes

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (day 1), week 26 and week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (day 1), week 26 and week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day 1), week 26 and week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Glycated Hemoglobin (HbA1c) From Baseline at Week 26

Percentage of Participants with Adverse Events as a Measure of Safety and Tolerability

Secondary study objectives

Change in Fasting Plasma Glucose (FPG) From Baseline at Week 26 and Week 52

Change in Glycated Hemoglobin (HbA1c) From Baseline at Week 52

Percent Change in Body Weight From Baseline at Week 26 and Week 52

+5 more

Other study objectives

Change in Body Mass Index (BMI) From Baseline at Week 26 and Week 52

Change in Bone Turnover Marker: Serum Collagen Type 1 Carboxy-Telopeptide (CTx) From Baseline at Week 26 and Week 52

Change in Bone Turnover Marker: Serum Osteocalcin From Baseline at Week 26 and Week 52

+8 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Canagliflozin 100 mg

2017

Completed Phase 3

~3030

Canagliflozin 300 mg

2017

Completed Phase 4

~3520