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A Section III, worldwide, randomized scientific trial assessed the security and efficacy of canagliflozin for the remedy of sort 2 diabetes mellitus (T2DM) in youngsters and adolescents.
The research discovered canagliflozin offered considerably better and clinically significant reductions in HbA1c in contrast with placebo, and the security profile was like that seen in adults. The outcomes help the usage of canagliflozin for T2DM in youngsters and adults, a inhabitants the place remedy choices are very restricted.
The findings are revealed in Annals of Inside Drugs.
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 nations.
Individuals 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 charge (eGFR) have been assessed at week 12.
On the week 13 go to, members with week 12 readings of seven% or increased for HbA1c and not less than 60 mL/min/1.73 m2 for eGFR have been randomly assigned once more to both proceed receiving their unique remedy task or have their dose uptitrated from 100 mg/d to 300 mg/d or matching placebo.
Therapy 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 adversarial occasions (AEs) and adversarial 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 obtained placebo. A sensitivity evaluation confirmed enchancment in HbA1c as early as week six that was maintained by way of the top of research remedy.
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 proportion 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 proportion 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 danger of hypoglycemic occasions was low, with no extreme hypoglycemic occasions occurring with canagliflozin remedy. The outcomes present that canagliflozin is protected, efficient, and well-tolerated amongst youngsters and adolescents aged 10 to 18 years with T2DM.
Extra info:
Therapy with Canagliflozin versus Placebo in Kids and Adolescents with Sort 2 Diabetes: A Randomized Scientific Trial, Annals of Inside Drugs (2025). DOI: 10.7326/ANNALS-24-04017
Editorial: www.acpjournals.org/doi/10.7326/ANNALS-25-02805
Supplied by
American School of Physicians
Quotation:
Section III research helps use of canagliflozin for sort 2 diabetes in youngsters and adolescents (2025, August 4)
retrieved 4 August 2025
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