Endocrine Abstracts

Introduction and Objective: Incidence of type 2 diabetes mellitus (T2D) is rapidly increasing resulting in significant metabolic disorders and complications. Dapagliflozin and sitagliptin have complimentary mechanism of action and have shown synergistic effects in controlling blood glucose levels with advantage of low risk of hypoglycemia. Use of fixed dose combinations (FDC) is associated with improved patient compliance. This is an Age Stratified analysis of electronic medical record (EMR) based study assessing effectiveness of dapagliflozin + sitagliptin FDC in patients with T2D.

Methods: In this real-world, retrospective, observational, EMR based 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 and sitagliptin FDC in any visit other than baseline visit on EMR platform were included. Patients on insulin or other injectable antidiabetic medications were excluded. Primary endpoint was mean change in HbA1c from baseline to 3 months in patients with HbA1c ≥8% at baseline. This is an age stratified-analysis of primary outcome.

Results: Total 3,112 patients fulfilled selection criteria, of which 838 patients were eligible for primary analysis. Patients were stratified in following age groups - Group 1: age ≤ 50 years (n=299); Group 2: 51-60 years (n=281); Group 3: 61-70 years (n=198) and Group 4: >70 years (n=60). Mean HbA1c reduced from 9.29% at baseline to 7.98% at 3 months (change -1.31%, P<0.001). Significant reduction in HbA1c from baseline to 3 months was observed in all age groups - Group 1: 9.31% vs 7.90% [change -1.41%]; Group 2: 9.29% to 7.97% [-1.32%]; Group 3: 9.22% vs 8.05% [-1.17%]; Group 4: 9.49% vs 8.13% [-1.35%]. Fasting and Postprandial blood glucose (FBG and PPBG) reduced significantly in all age strata from baseline to 3 months. FBG changes - Group 1: 175.67 to 137.27 (-38.4 mg/dl; (n=251), Group 2: 166.83 to 136.19 (-30.64 mg/dl; (n=236), Group 3: 161.77 to 128.26 (–33.51 mg/dl, (n=170), Group 4: 155.61 to 123.66 (–31.95 mg/dl; (n=53). PPBG changes - Group 1: 252.19 to 200.02 (-52.17 mg/dl; (n=205), Group 2: 254.08 to 201.32 (–52.76 mg/dl; (n=205), Group 3: 240.52 to 197.63 (–42.89 mg/dl; (n=154), Group 4: 246.10 to 202.52 (–43.58 mg/dl; (n=58). P<0.001 for all comparisons.

Conclusion: In patients with T2D and higher HbA1c value, Dapagliflozin+Sitagliptin FDC showed significant reduction in HbA1c, FBG and PPBG across all age groups. These findings highlight utility of Dapagliflozin+Sitagliptin FDC in managing T2D irrespective of age.