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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dc.contributor.authorBASU, Den_US
dc.contributor.authorPATRA, SKen_US
dc.contributor.authorBOKADIA, VKen_US
dc.contributor.authorKAPURE, NLen_US
dc.contributor.authorMAYABHATE, MMen_US
dc.contributor.authorSHARMA, ADen_US
dc.date.accessioned2025-06-18T11:36:32Z
dc.date.available2025-06-18T11:36:32Z
dc.date.issued2025-02
dc.description.abstractBackground: 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.en_US
dc.identifier.affiliationsSenior Consultant Diabetologist, Apollo Hospital, Kolkata, West Bengal, Indiaen_US
dc.identifier.affiliationsConsultant Diabetologist, Dr. Surajeet Patra’s Diabetes Centre, Bhubaneswar, Odisha, Indiaen_US
dc.identifier.affiliationsDirector and Head of Endocrinology Department, GBH American Hospital, Udaipur, Rajasthan, Indiaen_US
dc.identifier.affiliationsMedical Affairs, Alkem Laboratories, Mumbai, Maharashtra, Indiaen_US
dc.identifier.affiliationsMedical Affairs, Alkem Laboratories, Mumbai, Maharashtra, Indiaen_US
dc.identifier.affiliationsMedical Affairs, Alkem Laboratories, Mumbai, Maharashtra, Indiaen_US
dc.identifier.citationBASU 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): 1-5en_US
dc.identifier.issn0971-0876
dc.identifier.placeIndiaen_US
dc.identifier.urihttps://imsear.searo.who.int/handle/123456789/249127
dc.languageenen_US
dc.publisherIJCP Groupen_US
dc.relation.issuenumber9en_US
dc.relation.volume35en_US
dc.source.urihttps://ijcp.in/Admin/CMS/PDF/8.%20Retrospectivestudy_IJCPFeb2025.pdfen_US
dc.subjectType 2 diabetes mellitusen_US
dc.subjectdapagliflozinen_US
dc.subjectlinagliptinen_US
dc.subjectLEAD INDIAen_US
dc.subjectglycemic controlen_US
dc.titleEffectiveness 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 Studyen_US
dc.typeJournal Articleen_US
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