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

Completed · Phase 3 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

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 facts

Study ID

NCT03170518

Run by

Janssen Research & Development, LLC

People needed

171

Starts

2017-07-21

Expected to finish

2023-09-20

Last updated by the study team

2025-04-25

Who can join

Age: 10 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• On diet and exercise only for at least 4 weeks prior to screening
• On diet and exercise and a stable dose of metformin monotherapy >=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 <=15% change in the total daily dose of insulin [averaged over 1 week to account for day to day variability])
• On diet and exercise and a stable combination therapy with metformin and insulin for at least 8 weeks prior to screening

You may not qualify if…

• History of diabetic ketoacidosis (DKA), type 1 diabetes mellitus (T1DM), pancreas or cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy or maturity onset diabetes of the young (MODY)
• 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
• 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)

Where it is running

• Center of Excellence for Diabetes and Endocrinology (CEDE) — Sacramento, California, United States
• American Institute of Research — Whittier, California, United States
• University of Colorado School of Medicine/Children's Hospital Colorado — Aurora, Colorado, United States
• Nemours DuPont Hospital for Children — Wilmington, Delaware, United States
• TOPAZ Clinical Research — Apopka, Florida, United States
• Columbus Clinical Services LLC — Miami, Florida, United States
• Medical Research Center of Miami II Inc — Miami, Florida, United States
• Nicklaus Children's Hospital — Miami, Florida, United States
• Nemours Children's Hospital/Endocrinology — Orlando, Florida, United States
• Asclepes Research — Spring Hill, Florida, United States
• Johns Hopkins All Children's Hospital — St. Petersburg, Florida, United States
• Appalachian Clinical Research — Adairsville, Georgia, United States
• Endocrine Consultants Research — Columbus, Georgia, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• Capital Diabetes and Endocrine Associates — Camp Springs, Maryland, United States
• Floating Hospital For Children at Tufts Medical Center — Boston, Massachusetts, United States
• Alas Viable Research — Henderson, Nevada, United States
• University of New Mexico — Albuquerque, New Mexico, United States
• SUNY Downstate Medical Center — Brooklyn, New York, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• Carolinas Research Center, LLC — Charlotte, North Carolina, United States
• WakeMed Clinical Research Institute — Raleigh, North Carolina, United States
• PMG Research of Wilmington, LLC — Wilmington, North Carolina, United States
• Cleveland Clinic Center for Pediatric Endocrinology — Cleveland, Ohio, United States
• Arkansas Childrens Hospital — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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