2349-PUB: Long-Term Efficacy and Safety of Canagliflozin in Type 2 Diabetes: A 52-Week Indian Experience

Introduction: SGLT2 inhibitors are a new class of drugs approved for type 2 diabetes (T2DM) and have been placed high in treatment algorithm following the robust data supporting their use. Aim: We studied the long term efficacy and safety of Canagliglozin (CANA) versus placebo in Indian adults with type 2 diabetes who were inadequately controlled with metformin (MET) monotherapy. Methods: The study was undertaken at Sevayan Diabetes Centre, India with due consent from participants. Patients (HbA1c 8-12%) on MET were invited to participate. Those on other antidiabetic drugs or insulin were excluded. The CANA arm was administered CANA 100mg OD in addition to MET. The other group received placebo (PBO) and MET. Doses of MET were kept unchanged throughout the study. Antihypertensive, statin and antiplatelets were continued unchanged. Participants were compared after 52 weeks of enrollment. Result: Data of 96 (M/F 62/34) subjects were available for analysis (n=46 on CANA, n=50 on PBO). Groups were similar at baseline. Pre-enrollment HbA1c (%), FPG (mg%) and PPG (mg%) in CANA and PBO arm were 9.94±1.04 and 9.89±1.1, 193.2±26.1 and 193.6±33.0 and 261.3±28.1 and 260.5±30.3 in order (p=NS for all). After 52 weeks of treatment, CANA arm showed clinically meaningful 1.61±1.05% reduction in HbA1c from baseline (p= 0.0048), whereas the PBO arm witnessed a non-significant elevation in HbA1c. Use of CANA significantly decreased FPG by 60.05±17.75mg% and PPG by 62.35±21.92 mg%, whereas the PBO group noticed no appreciable changes in those glycemic parameters. Mycotic infections were common in CANA users (n=6 vs. n=3 in PBO), but improved with personal hygiene. Incidences of documented hypoglycemia were similar in both groups (12 in each). Conclusion: In Indian diabetics uncontrolled with metformin monotherapy, addition of canagliflozin resulted in statistically significant and durable reductions in HbA1c, FPG and PPG over 52 weeks period. Participants tolerated CANA well without any additional risk of hypoglycemia.