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Real-World Prescribing Patterns and Clinical Characteristics of Patients With Type 2 Diabetes Mellitus Receiving Empagliflozin-Sitagliptin-Metformin Fixed-Dose Combination Therapy

Naik BT, Y S, Patro D, Pankaj S, Gaur M, Paulose G, Kate R, Gude D et al.

Cureus, 2026

12,843 participants

Abstract

Background: Type 2 diabetes mellitus (T2DM) is associated with substantial cardiovascular and renal morbidity, necessitating individualized treatment strategies that target multiple pathophysiological mechanisms. Triple fixed-dose combination (FDC) therapy comprising empagliflozin, sitagliptin, and metformin (ESM) is used in routine clinical practice; however, real-world data describing the clinical characteristics and prescribing patterns of patients receiving this combination in India remain limited.

Methods: This multicentric, retrospective, cross-sectional real-world evidence study evaluated demographic characteristics, clinical profiles, comorbidities, glycemic parameters, renal function, and prescribing patterns among adult patients with T2DM receiving empagliflozin-, sitagliptin-, and metformin-based triple FDC therapy in India. Patients receiving empagliflozin 25 mg + sitagliptin 100 mg + metformin 1000 mg (ESM-25) or empagliflozin 10 mg + sitagliptin 100 mg + metformin 1000 mg (ESM-10) were included in the analysis.

Results: A total of 12,843 patients were included, comprising 7,060 receiving ESM-25 therapy and 5,783 receiving ESM-10 therapy. Most patients were aged >50 years (64.2% in both groups), and males constituted 60.4% and 61.2% of the ESM-25 and ESM-10 groups, respectively. Physicians and diabetologists accounted for the majority of prescriptions. Comorbidities were documented in the available medical records for 12.0% of patients, with hypertension and…

How strong is the evidence?

Evidence Hub reads this as a cross-sectional, done in people. Its evidence level is 4 of 5 (Low · observational). Observational designs can show an association but not prove cause. Reported size: 12,843 participants or records.

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