Phase 3 N=171 Randomized Double-blind Treatment

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

Diabetes Mellitus, Type 2

Bottom Line

View on ClinicalTrials.gov: NCT03170518 ↗

Enrolled (actual)

171

Serious AEs

7.6%

Results posted

Mar 2025

Primary outcome: Primary: Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26 — 0.39; -0.37 Percent (%) of HbA1c — p== 0.002

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Canagliflozin 100 mg (Drug); Canagliflozin 300 mg (Drug); Placebo (Drug)
Age: Pediatric · 10+ yrs
Sex: All
Sponsor: Janssen Research & Development, LLC
Primary completion: Sep 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26	0.39; -0.37	= 0.002 sig
PRIMARY Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)	74.7; 76.1; 82.4	—
SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 26 and 52	15.3; -11.5; 19.2; -16.4	—
SECONDARY Percentage of Participants With HbA1c Less Than (<)7.5 Percent (%), <7%, and <6.5% at Weeks 26 and 52	40.0; 64.9; 29.3; 69.0; 27.5; 51.9	—
SECONDARY Percentage of Participants Who Received Rescue Therapy	46.0; 11.9	—
SECONDARY Time to Rescue Therapy	21.50; 24.14	—
SECONDARY Percent Change From Baseline in Body Weight at Weeks 26 and 52	-0.0; -1.6; 0.4; -0.5	—
SECONDARY Change From Baseline in Body Mass Index (BMI) at Weeks 26 and 52	-0.4; -0.8; -0.5; -0.7	—
SECONDARY Percent Change From Baseline in Fasting Plasma Lipids Levels at Weeks 26 and 52	1.2; 8.2; 5.6; 5.1; 3.3; 12.4	—
SECONDARY Percent Change From Baseline in LDL-C to HDL-C Ratio and Non-HDL-C to LDL-C Ratio at Weeks 26 and 52	0.5; 2.5; -1.5; 4.0; 1.1; 3.3	—
SECONDARY Change From Baseline in Systolic Blood Pressure at Weeks 26 and 52	1.4; 0.7; 1.5; 0.0	—
SECONDARY Change From Baseline in Diastolic Blood Pressure at Weeks 26 and 52	-0.1; -0.1; 0.7; -0.2	—
SECONDARY Change From Baseline in HbA1c at Weeks 12 and 52	0.10; -0.59; 0.70; -0.32	—
SECONDARY Growth Velocity at Weeks 26 and 52	2.08; 1.94; 1.00; 1.63; 1.46; 1.76	—
SECONDARY Number of Participants With Changes in Tanner Staging (Females) From Baseline at Weeks 26 and 52	1; 2; 1; 1; 0; 0	—
SECONDARY Number of Participants With Changes in Tanner Staging (Males) From Baseline at Weeks 26 and 52	0; 0; 1; 0; 0; 1	—
SECONDARY Change From Baseline in Bone Turnover Marker: Serum Osteocalcin and Serum Collagen Type 1 Carboxy-Telopeptide (CTx) at Weeks 26 and 52	-3.594; -3.328; -0.904; -8.732; -5.964; -3.475	—
SECONDARY Urinary Albumin/Creatinine Ratio (ACR) at Weeks 26 and 52	15.62; 14.41; 24.84; 14.98; 15.45; 21.27	—

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.

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 ( =1,000 mg per day or MTD per day for at least 8 weeks prior to screening
On diet and exercise and a stable insulin monotherapy regimen for at least 8 weeks prior to screening (stable dose is defined as no change in the insulin regimen [that is, type{s} of insulin] and 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
History of hereditary glucose-galactose malabsorption or primary renal glucosuria
Alanine aminotransferase level >5.0 times the upper limit of normal (ULN) or total bilirubin >1.5 times the ULN at screening (for elevations in bilirubin: if, in the opinion of the investigator and agreed upon by the sponsor's medical officer, the elevation in bilirubin is consistent with Gilbert's disease, the subject may participate)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03170518). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.