Efficacy of Fixed-dose Combination of Dapagliflozin and Sitagliptin in Type 2 Diabetes Mellitus Using Continuous Glucose Monitoring: A Real-world Study in India

Background: Type 2 diabetes mellitus (T2DM) is a progressive disease with multifactorial aetiology. Metformin monotherapy is commonly used as the initial treatment, but is often inadequate in achieving optimal glycaemic control, necessitating the need of second and third-line therapies. Fixed dose combination (FDC) of dapagliflozin and sitagliptin in Indian setting is gaining popularity. Time-in-target has become a useful blood glucose indicator that goes "beyond HbA1c" to understand glycaemic control in people with diabetes better.

Aims and Objectives: To assess the efficacy of a FDC of dapagliflozin and sitagliptin in Indian T2DM patients.

Materials and Methods: This was a single-arm, single-centre, real-world study. Twenty-eight consented T2DM patients age >18 years, either sex, not hospitalized, and estimated glomerular filtration rate >60 ml/min/1.73m2 were administered a continuous glucose monitoring system (CGMS) (Freestyle Libre Pro). Once daily fixed-dose combination (FDC) of dapagliflozin (10mg) and sitagliptin (100mg) was given along with CGMS administration on a background of existing therapy for those who were not to target for glycemic parameters. Since the FDC reaches at its peak concentration after 3-4 days of administration, the efficacy of FDC was considered from 5th day. Hence the baseline was calculated taking the mean of first 4 days after FDC administration. Patients' characteristics, including age (years), sex, weight (kg), body mass index (kg/m2), estimated glycated haemoglobin (%), history of oral hypoglycaemic agents, and dose of insulin were recorded. For efficacy assessment, average daily glucose (ADG), time in target (TIT), time below target (TBT), and time above target (TAT) were recorded at baseline.) and end of the study (day 15th of CGMS administration) from the daily glucose summary of Freestyle Libre Pro CGMS. The percentage improvement of each efficacy parameters were assessed.

Results: A statistically significant improvement (p<0.05) in ADG (19.41% decrease), TIT (34.47% increase), and TAT (31.13% decrease) was observed, whereas TBT was increased by 29.23%; which was statistically non-significant. Mean age (n=28), weight (n=23), body mass index (n=19) and estimated HbA1c (n=19) was 56.70±9.8 years, 64.67±9.52 Kg, 24.99±4.23 Kg/m2 and 6.84±1.63 % respectively. The majority were on triple drug (n=14; 50%) therapy before CGMS administration than dual (n=5; 17.9%) and monotherapy (2; 7.1%). Fifteen (53.8%) were on insulin with a mean insulin dose of 16.40 IU.

Conclusion: Once daily FDC of dapagliflozin and sitagliptin in Indian T2DM patients significantly improves AGD, TIT, and TAT at the end of 15 days.