A Part III, worldwide, randomized medical trial assessed the protection and efficacy of canagliflozin for the therapy of sort 2 diabetes mellitus (T2DM) in youngsters and adolescents.
The examine discovered canagliflozin supplied considerably better and clinically significant reductions in HbA1c in contrast with placebo, and the protection profile was like that seen in adults. The outcomes help using canagliflozin for T2DM in youngsters and adults, a inhabitants the place therapy choices are very restricted.
The findings are printed in Annals of Inside Medication.
Researchers from Johnson & Johnson studied information from 171 youngsters aged 10 to 18 years with T2DM and insufficient glycemic management between 28 July 2017 and 20 September 2023 at 104 websites throughout 10 international locations.
Contributors have been randomly assigned 1:1 to obtain both oral canagliflozin (100 mg) or matching placebo as soon as each day. Their HbA1c and estimated glomerular filtration fee (eGFR) have been assessed at week 12.
On the week 13 go to, members with week 12 readings of seven% or larger for HbA1c and at the least 60 mL/min/1.73 m2 for eGFR have been randomly assigned once more to both proceed receiving their authentic therapy project or have their dose uptitrated from 100 mg/d to 300 mg/d or matching placebo.
Remedy continued for a complete of 52 weeks. The first efficacy endpoint was change in HbA1c at week 26. Key secondary endpoints included change in HBA1c at week 52, change in fasting plasma glucose, and alter in physique weight at weeks 26 and 52. Security assessments included monitoring for hostile occasions (AEs) and hostile occasions of particular curiosity, together with hypoglycemic occasions.
The researchers discovered that at week 26, members receiving canagliflozin had considerably better HbA1c enchancment in comparison with those that acquired placebo. A sensitivity evaluation confirmed enchancment in HbA1c as early as week six that was maintained via the top of examine therapy.
At week 52, a better proportion of members receiving canagliflozin had an HBA1c lower than 6.5% (MP, 30.9% vs. 15.6%; distinction in MP, 15.2 share factors [CI, 3.4 to 27.1 percentage points]) or lower than 7.0% (MP, 47.2% vs. 28.9%; distinction in MP, 18.3 share factors [CI, 6.6 to 30.0 percentage points]).
Fasting plasma glucose ranges considerably improved at week 26 in members receiving canagliflozin in comparison with placebo.
The most typical treatment-emergent AEs amongst members taking canagliflozin have been complications, nasopharyngitis, urinary tract an infection, and vomiting. The chance of hypoglycemic occasions was low, with no extreme hypoglycemic occasions occurring with canagliflozin therapy. The outcomes present that canagliflozin is protected, efficient, and well-tolerated amongst youngsters and adolescents aged 10 to 18 years with T2DM.
Extra info:
Remedy with Canagliflozin versus Placebo in Kids and Adolescents with Kind 2 Diabetes: A Randomized Medical Trial, Annals of Inside Medication (2025). DOI: 10.7326/ANNALS-24-04017
Quotation:
Part III examine helps use of canagliflozin for sort 2 diabetes in youngsters and adolescents (2025, August 4)
retrieved 5 August 2025
from https://medicalxpress.com/information/2025-08-phase-iii-canagliflozin-diabetes-children.html
This doc is topic to copyright. Other than any truthful dealing for the aim of personal examine or analysis, no
half could also be reproduced with out the written permission. The content material is supplied for info functions solely.
