Background: Remogliflozin had recently got approval in India as new SGLT2i and also there was a storm of Vildagliptin generics after it loses its exclusive marketing patent.
Method: This was a 48 weeks prospective observational study (N=254, age ≥ 35 years with HbA1c ≥ 7%). According to investigator decision, eligible patients were assigned either remogliflozin 100 mg BD ( N=980) or Vildagliptin 50 mg BD (N= 1420) in patients who were initially uncontrolled on metformin 1000 mg alone in single or divided doses for atlas 6 weeks. Primary outcome was change in HbA1c, FBS and PPBS, secondary outcome was proportion of patients with HbA1c<7% and change in SBP and DBP.
Results: Initially 300 patients were selected but 254 patients completed the study. At baseline, mean age was 57.8±6.3 years, HbA1c 8.2±1.2%, BMI 30.1±1.7 kg/m2, and diabetes duration 5.2±1.2 years. Mean HbA1c, FBS and PPBS was significantly reduced in both the group (p<0.001) from the baseline. Between the two groups there was no statistically significant differences in mean reduction of FBS and PPBS levels (p>0.05). However, mean HbA1c% was slightly more reduced in remogliflozin plus metformin group (-1.2±0.3%; 8.1±1% to 6.9±0.5%, p>0.001) than vildagliptin plus metformin (-1±0.3%;8.3±1.3% to 7.3±0.6%, p>0.001). 62% patients on remogliflozin were achieved target HbA1c level within 24 weeks where as it was 57% with vildagliptin group. Differences were found in: SBP -7.92 mmHg (p <0.0001); DBP -3.67 mmHg (p <0.0001) in remogliflozin group while in other group it was no significant. There was a significant change in weight (-2.34 kg, p <0.0001) with remogliflozin as compare to vilda group (-1.1 Kg, p<0.005). The incidence of hypoglycemia was low in all groups (<2%).
Conclusion: In conclusion, both therapies yielded similar improvements in glucose control. However, the adherence was better with remogliflozin.
A. K. Sinha: None.
