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

Conditions

• Diabetes Mellitus, Type 2

Eligibility Criteria

Sex

ALL

Age

10 Years - 17 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Jul 21, 2017

Status verified

Apr 2025

Primary completion

Sep 20, 2023

Completion

Sep 20, 2023

Study Design

Enrollment

171 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Single-blind run-in Period: Placebo
  Participants will receive 1 placebo tablet matching canagliflozin 100 milligram (mg) once-daily during the 2-week single-blind placebo run-in period.
• Experimental: Double-blind Treatment Phase: Canagliflozin or Placebo
  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.

Primary Outcome Measure

Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26 [ Time Frame: Baseline (Day 1) and Week 26 ]

Locations (36)

Related coverage on Hipa.ai

• Canagliflozin Reduces HbA1c in Pediatric Type 2 Diabetes Mellitus
  Canagliflozin · Mar 12, 2025 · ClinicalTrials.gov

Find similar trials in Little Rock, AR

Related Studies

• Pre-diabetes in Subject With Impaired Fasting Glucose (IFG) and Impaired Glucose Tolerance (IGT)
  Recruiting · The University of Texas Health Science Center at San Antonio · San Antonio, Texas
• Tau PET Imaging in the Northern Manhattan Study of Metabolism and Mind.
  PHASE2 · Enrolling By Invitation · Columbia University · New York, New York
• Phenotyping Genetic Risk for Type 2 Diabetes
  Recruiting · University of Pennsylvania · Philadelphia, Pennsylvania
• Use of CGM in Kidney Transplant Recipients
  Recruiting · University of California, Davis · Sacramento, California