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

Abstract

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.