Aim: Remogliflozin is a new SGLT2i for the treatment of type 2 diabetes mellitus approved in India. The primary objective of this study was to compare remogliflozin to canagliflozin in patient populations with inadequately controlled (HbA1c>8%) and already treated with either diet/exercise, metformin plus a DPP-4i.
Method: 120 uncontrolled T2DM subjects (HbA1c>8%) who were on optimum tolerable dose of metformin plus a DPP-4i, were selected for this real world observational trial. Primary end point was change from baseline in HbA1C at 12 weeks. Secondary end points included change in fasting plasma glucose (FPG) and post prandial plasma glucose (PPPG), and percent change in body weight. Safety was assessed based on adverse event (AE) like hypoglycemia reports.
Result: A comparable reduction in HbA1c were observed from baseline at the end of 12 weeks in both groups, remogliflozin 100 mg (N=60) (1.96%) (p>0.001)and canagliflozin 300 mg (N=60) (1.67%)(p>0.001), but inter group p value was non-significant(p=0.023). A similar significant reduction was demonstrated in both FPG (47.98% vs. 41.23%) and PPPG (49.81% vs. 42.89%) in remogliflozin group compared to canagliflozin group respectively. The proportion of patients who achieved an HbA1C < 7% at 12 weeks was 51% in the remogliflozin group and 43% in the canagliflozin group. Statistically significant more weight loss was observed in remogliflozin arm compared to canagliflozin arm (-1.38 kg vs. -0.88 kg)(p>0.001). The overall incidence of hypoglycemia (minor) was higher in patients treated with canagliflozin as compared to the patients treated with remogliflozin. The two groups differ in their cost effect, as treatment with canagliflozin group was 4.3 fold costlier than with remogliflozin till 3 months of treatment.
Conclusion: Effectiveness of remogliflozin is as comparable with canagliflozin as GLA. In country like India where cost is matter for compliance remogliflozin can be substitute of canagliflozin.
A. Shankar: None.