Efficacy and Safety of Canagliflozin 300 mg in Overweight and Obese Type 2 Diabetes Mellitus Patients in a Real-world Setting: COLOR Study

BACKGROUND AND AIMS: To assess the efficacy and safety of canagliflozin (CANA, 300 mg/d) in overweight and obese patients with type 2 diabetes mellitus (T2DM). METHODS: In a single centre, retrospective, observational study, we included overweight or obese patients with T2DM who had HbA1c >7% and received CANA as addition to existing therapy for at least 24 weeks. Primary endpoint assessed was changes in HbA1c, fasting and post-prandial plasma glucose (FPG and PPG), and secondary endpoints included changes in weight, waist circumference (WC), systolic blood pressure (SBP) and diastolic BP (DBP) over 12 and 24 weeks. RESULTS: Among 90 patients, mean age was 53.5 ± 10.8 years and 42.2% were females. Majority of the patients (46.7%) were receiving two antidiabetic drugs. Significant reduction in HbA1c from baseline to week 24 (9.1 ± 1.8% vs. 7.5 ± 1.1% respectively, mean difference: - 1.6 ± 0.9%, P < 0.0001) was seen. Reduction in FPG (mean difference: - 63.0 ± 45.2 mg/dL, P < 0.0001) and PPG (mean difference: - 97.7 ± 54.3 mg/dL, P < 0.0001) was also significant. Mean reduction in weight was - 4.3 ± 2.2 kg (P < 0.0001) at 24 weeks. Reductions in WC, SBP and DBP were also significant at week 24 (P < 0.0001 for all). Changes in all these parameters were also significant at week 12. Proportion of patients achieving the target HbA1c of <7% was 28.9% and 52.2% at week 12 and week 24, respectively. Genital mycotic infections were seen in 20% patients and was present in higher proportion of females than males (28.9% vs. 13.5%, P = 0.070). No episodes of hypoglycaemia were found. CONCLUSION: Canagliflozin should be considered from among the various antidiabetic drugs in overweight and obese patients with T2D in India.