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
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Date
2025-02
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Publisher
IJCP Group
Abstract
Background: Glimepiride/metformin is commonly used in India for its cost-effectiveness and efficacy, but one-third of patients may not achieve adequate glycemic control. Dapagliflozin/linagliptin fixed-dose combination (FDC) could be an effective alternative. 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. Changes in HbA1c, fasting plasma glucose (FPG)/postprandial plasma glucose (PPG), blood pressure, and body weight were analyzed over 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/linagliptin demonstrated significant reduction in HbA1c (from mean 8.8 ± 1.12 to 6.92 ± 0.23; p < 0.001), FPG (157.8 ± 28.86 mg/dL to 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 improved glycemic 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. Treatment was well-tolerated. Conclusion: FDC of dapagliflozin/linagliptin is an attractive therapeutic option for patients with type 2 diabetes mellitus not controlled with ongoing glimepiride and metformin.
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Keywords
Type 2 diabetes mellitus, dapagliflozin, linagliptin, LEAD INDIA, glycemic control
Citation
BASU D, PATRA SK, BOKADIA VK, KAPURE NL, MAYABHATE MM, SHARMA AD. 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. Indian Journal of Clinical Practice. 2025 Feb; 35(9): 1-5