Effectiveness and Safety of Fixed-Dose Combination of Dapagliflozin and Linagliptin in Patients not Controlled on Glimepiride and Metformin in Real-World Settings in India: LEAD INDIA Study

Glimepiride/metformin is commonly used in India for its cost-effectiveness and efficacy, but one-third of patientsmay not achieve adequate glycemic control. Dapagliflozin/linagliptin fixed-dose combination (FDC) could be an effectivealternative. Methods: A retrospective study of type 2 diabetes patients aged >18 years, not meeting glycated hemoglobin(HbA1c) goal <7% on glimepiride and metformin. Patients received dapagliflozin (10 mg)/linagliptin (5 mg) FDC. Changesin HbA1c, fasting plasma glucose (FPG)/postprandial plasma glucose (PPG), blood pressure, and body weight were analyzedover 3 months. Results: The study included patient (n = 114) with a mean age of 55.15 years and mean duration of 8.5 years.Adjunct to dietary/lifestyle modifications, up-titration of metformin-glimepiride along with FDC of dapagliflozin/linagliptindemonstrated significant reduction in HbA1c (from mean 8.8 ± 1.12 to 6.92 ± 0.23; p < 0.001), FPG (157.8 ± 28.86 mg/dLto 113.6 ± 9.24 mg/dL; p < 0.001), and PPG (237.21 ± 40.58 mg/dL to 161.39 ± 12.76 mg/dL; p < 0.001) indicating improvedglycemic control. Additionally, there was a marginal decrease in body weight (73.19 to 72.12 kg), systolic blood pressure(137.6 to 129.11 mmHg), and diastolic blood pressure (84.26 to 78.68 mmHg) largely attributed to dapagliflozin. Treatmentwas well-tolerated. Conclusion: FDC of dapagliflozin/linagliptin is an attractive therapeutic option for patients with type 2diabetes mellitus not controlled with ongoing glimepiride and metformin.