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Demonstrates improved glycemic control in insulin-naïve patients with Type 2 Diabetes, suggesting potential in simplifying management.
Introduction and Objective: Insulin is a cornerstone therapy for type 2 diabetes (T2D) but is associated with weight gain, hypoglycemia, increased healthcare utilization, and treatment burden. SGLT2 inhibitors have been shown to lower rates of insulin initiation; however, whether this effect is dose-dependent remains unclear. This subanalysis of the INTENSIFY study assessed, in a real-world setting, the effectiveness and tolerability of dose escalation to canagliflozin 300 mg/day (CANA300) in insulin-naïve patients with T2D previously treated with canagliflozin 100 mg/day (CANA100) who met criteria for insulin initiation. Methods: Insulin-naïve patients receiving ≥3 non-insulin antihyperglycemic agents (including CANA100) with A1c >7% at escalation to CANA300 were analyzed. Endpoints were changes in A1c and body weight, proportions achieving A1c <7% or <8%, and requirement for insulin during follow-up. Results: Ninety-five patients (30% of the INTENSIFY cohort) were included. Mean age was 64.2 years; 63.2% were male; mean A1c was 7.81%; and mean BMI was 30.0 kg/m². At escalation, 71.6% were on triple therapy and 28.4% on quadruple therapy. Background therapy included metformin (97.9%), DPP-4 inhibitors (53.7%), GLP-1RAs (45.3%), sulfonylureas/glinides (28.4%), and pioglitazone (3.2%). Over a median follow-up of 15 months, escalation to CANA300 significantly reduced A1c (−0.64%) and body weight (−3.0 kg); both p<0.0001. Mean final A1c was 7.20%. Insulin was not initiated in 85.1% of patients; 49.4% achieved A1c <7% and 90.5% achieved A1c <8% without insulin. CANA300 was discontinued in 7.4%. Genital mycotic infections occurred in 10.5% and urinary tract infections in 4.2%. No volume depletion, amputations, or ketoacidosis were reported. Conclusion: In real-world practice, intensification from CANA100 to CANA300 improved glycemic control and prevented insulin initiation in most insulin-eligible patients, attaining adequate control in nearly half. This approach may help simplify diabetes management. Disclosure J.J. Gorgojo-Martinez: Advisory Panel; Current; Abbott. Speaker's Bureau; Ended; Bayer AG. Advisory Panel; Ended; Novo Nordisk. Speaker's Bureau; Ended; Novo Nordisk. Advisory Panel; Ended; Menarini Group. Speaker's Bureau; Ended; Menarini Group, AstraZeneca, Esteve. Speaker's Bureau; Current; Amarin Corporation, Daiichi Sankyo. Advisory Panel; Current; Boehringer Ingelheim International GmbH. Speaker's Bureau; Ended; Novartis AG. P. Ferreira-Ocampo: None. A. Galdón Sanz-Pastor: None. J. Cárdenas-Salas: Speaker's Bureau; Ended; Menarini Group, Novo Nordisk, AstraZeneca. Other - funding for attending conferences; Ended; Menarini Group, Lilly, Novo Nordisk. T. Anton Bravo: None. M. Brito-Sanfiel: Advisory Panel; Ended; Lilly. Speaker's Bureau; Ended; Lilly, Novo Nordisk. Advisory Panel; Ended; Menarini Group. Speaker's Bureau; Ended; Menarini Group, Daiichi Sankyo, Novartis AG, Almirall, S.A., Italfarmaco, Sanofi, Bayer AG, AstraZeneca, Boehringer Ingelheim International GmbH. F. Almodóvar-Ruiz: None.
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GORGOJO-MARTINEZ et al. (2026) studied this question.
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