Endocrine Abstracts

Introduction and Objective: Escalating prevalence of type 2 diabetes mellitus (T2D) in India presents a significant health challenge. Dapagliflozin and sitagliptin are important treatments for achieving glycaemic control in patients with T2D. Dapagliflozin promotes weight loss benefiting overweight and obese patients, while sitagliptin enhances incretin hormone activity with modest weight loss. This is a BMI-stratified analysis of electronic medical record (EMR) based real world, retrospective study assessing effectiveness of dapagliflozin+sitagliptin FDC in patients with T2D.

Methods: In this study, data of adult patients (age ≥18 years) of either gender with T2D having HbA1c ≥7% at baseline were included. Patients who were prescribed dapagliflozin+sitagliptin FDC in any visit other than baseline visit on EMR platform were included. Patients on insulin or other injectable antidiabetic medication were excluded. Primary endpoint was mean change in HbA1c from baseline to 3 months in patients with HbA1c ≥ 8% at baseline. This is a BMI Stratified-analysis of primary outcome.

Results: Total 3112 patients fulfilled selection criteria, of which 838 patients were eligible for primary endpoint. Mean HbA1c at baseline was 9.29% which reduced to 7.98% at end of 3 months with reduction of -1.31% (P<0.001). Patients were stratified per BMI (n=466): Group 1 (Normal: 18.50-22.99 kg/m²; n=41), Group 2 (Overweight:23.00-24.99 kg/m², n=64), and Group 3 (Obese:≥25.00 kg/m²; n=361). Significant reduction in HbA1c from baseline to 3 months in all BMI groups was seen; Group 1: 9.26% to 7.90% [change -1.36%]; Group 2: 9.34% to 7.90% [-1.44%]; Group 3: 9.19% to 7.97% [-1.22%] (P<0.001 for all comparisons). Fasting and Postprandial blood glucose (FBG and PPBG) reduced significantly in all BMI strata. FBG changes -Group 1: 165.21 to 139.78 [-25.43 mg/dl; n=35], Group 2: 162.85 to 124.73 [-38.12 mg/dl; n=56], Group 3: 163.91 to 134.17 [-29.74 mg/dl; n=303]. PPBG changes -Group 1: 248.24 to 200.69 (Change -47.55 mg/dl; n=34), Group 2: 231.96 to 188.74 (-43.22 mg/dl; n=51), Group 3: 244.22 to 197.97 (-46.25 mg/dl; n=249) (P<0.001 for all comparisons). In patients with BMI >23 kg/m²;, weight reduced from 74.2 to 73.6 kg [change -0.6] at 3 months (n=649) and 73.76 to 73.12 kg [-0.64 kg] at 6 months (n=334). In patients with BMI >25 kg/m²;, weight reduced from 76.31 to 75.65 kg [-0.66 kg] at 3 months (n=537) and 75.92 to 75.12 [-0.8 kg] at 6 months (n=273) (P<0.0001 for all changes).

Conclusions: Dapagliflozin+sitagliptin FDC demonstrated significant improvement in HbA1c reduction in patients with T2DM and higher HbA1c across BMI groups suggesting it as an effective therapeutic option in patients with varying BMI.