(16.06) Study on Effectiveness in Real-world with Dapagliflozin and Sitagliptin Fixed dose combination in patients with Type 2 Diabetes Mellitus in India: Retrospective Study from Electronic Medical Records

Type 2 diabetes mellitus (T2DM) is a significant health concern globally, including in India, where the prevalence of diabetes is high. As its incidence is rapidly increasing, and more treatment options are evolving, there is a need to evaluate the effectiveness of these different treatment options in real-world settings. SGLT2i are frequently used with DPP4 for superior glycemic control and other benefits. SGLT2i and DPP4i have complementary mechanisms of action and their fixed-dose combination (FDC) can help in improving patient compliance. This study assessed real-world effectiveness of this novel FDC of dapagliflozin and sitagliptin in Indian patients in a retrospective, observational, electronic medical record (EMR) based study.

Methods:

EMRs of patients with T2DM aged ≥18 years having HbA1c ≥7% at baseline who were prescribed with dapagliflozin and sitagliptin FDC and had follow-up data at 3±1 month and/or 6±1 month from baseline visit/index date of the prescription was considered for the study. Primary endpoint was mean change in HbA1c from baseline to 3 months in patients with HbA1c ≥8% at baseline.

Results:

Of 3,112 EMRs included, 838 were eligible for primary endpoint assessment. Mean HbA1c at baseline was 9.29% which reduced to 7.98% at 3 months (change from baseline [CFB] -1.31; p< 0.001). CFB in fasting blood glucose (FBG) (n=710; 167.9±55.3 to 133.7±40.0; CFB: -34.2±57.8; p< 0.0001) and in post-prandial blood glucose (PPBG) (n=622; 249.4±72.1 to 200.1±62.38; CFB=-49.3±80.2; p< 0.0001) was significant at 3 months.

Patients for whom 3- and 6-months’ data was available (n=146), CFB in HbA1c was significant at 3 months (9.19% to 8.03%, CFB: -1.16; p< 0.001) and 6 months (9.19% to 7.86%, CFB: -1.33; p< 0.001). In patients with baseline HbA1c ≥7%, significant reduction in HbA1c was observed at 3 months (n=1,418) and at 3 and 6 months (n=261).

Significant reduction in HbA1c was observed irrespective of patients’ age, gender, BMI and presence of cardiovascular (CV) comorbidities. In patients with baseline HbA1c≥8% and BMI >25kg/m² (n=649), there was a significant reduction in body weight from baseline at 3 months (76.31kg to 75.65kg; CFB: -0.66; p< 0.0001).

Discussion/Conclusion:

Dapagliflozin + Sitagliptin FDC was effective in overall glycemic control in T2DM patients. The FDC was also effective in patients with CV comorbidities and irrespective of patients’ age, gender, and BMI. The combination was also effective in significantly reducing body weight. Thus, FDC of dapagliflozin + sitagliptin was shown to be effective treatment option in patients with T2DM in real-world setting.