Durability of glycemic response with FDC of sitagliptin and metformin in treatment naive T2DM indian patients from a real-world retrospective EMR based study

Pranav Sheth; Parag Shah; Prachi Ahire; Bharadwaja Pendurthi; Shruti Dharmadhikari; Chintan Khandhedia; Neeraj Markandeywar; Amey Mane; Suyog Mehta

doi:10.1530/endoabs.110.EP410

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Endocrine Abstracts (2025) 110 EP410 | DOI: 10.1530/endoabs.110.EP410

ECEESPE2025 ePoster Presentations Diabetes and Insulin (245 abstracts)

Durability of glycemic response with FDC of sitagliptin and metformin in treatment naive T2DM indian patients from a real-world retrospective EMR based study

Pranav Sheth ¹ , Parag Shah ² , Prachi Ahire ³ , Bharadwaja Pendurthi ¹ , Shruti Dharmadhikari ¹ , Chintan Khandhedia ¹ , Neeraj Markandeywar ¹ , Amey Mane ¹ & Suyog Mehta ¹

Author affiliations

¹Sun Pharma Laboratories Ltd, Mumbai, India; ²Gujarat Endocrine Centre, Ahmedabad, India; ³Sun Pharmaceutical Industries Ltd, Mumbai, India

JOINT3321

Background and aims: We conducted a real-world, retrospective, observational, electronic medical records (EMR) based study to understand the effectiveness of sitagliptin and sitagliptin + metformin fixed-dose combination (FDC) in Indian patients with type 2 diabetes mellitus (T2DM). The data here presents a subgroup analysis of treatment naïve T2DM patients who received sitagliptin + metformin FDC.

Materials and methods: Aggregated and anonymised EMR data of adult (age ≥18 years) male and female patients having T2DM, who were prescribed with sitagliptin or sitagliptin + metformin FDC, with or without other oral anti-diabetic medicines and had data available for baseline and follow-up visits from 2017 to 2023 was retrieved. Patients who were on insulin or any other injectable antidiabetic medication like Glucagon-like peptide-1 agonists were excluded. This subgroup analysis assessed the effectiveness of sitagliptin + metformin FDC on glycosylated haemoglobin (HbA1c) levels of naïve patients from baseline to 3 months and 9 months. The study was registered on Clinical Trial Registry – India (CTRI/2023/10/058366)

Results: EMR data was available for 986treatment-naive patients with HbA1c ≥7%, who received sitagliptin + metformin FDC. The follow up data for 315 patients was available at 3 months and for 118 patients at 9 months. Mean HbA1c at baseline was 8.94 ± 1.78 in patients with 3 months’ data (n =315) and it was 8.71 ±1.60 in patients with 9 months’ data (n =118). Mean change from baseline (CFB) in HbA1c at 3 months (8.94 ± 1.78 to 7.33 ± 1.05; CFB: -1.61 ± 1.83, P<0.0001) was statistically significant. Mean CFB in HbA1c at 9 months (8.71± 1.60 to 7.45 ± 1.29; CFB: -1.26 ± 1.90, P<0.001) was also statistically significant. Proportion of patients achieving HbA1c <7% in sitagliptin + metformin FDC arm was 40.32% at 3 ± 1 month and 44.07% at 9 ± 1 month.

Conclusion: This subgroup analysis of EMR based study in India demonstrated effectiveness of sitagliptin and metformin FDC, in significantly improving HbA1c and providing durable control over 9 months in treatment-naïve T2DM patients in a real-world setting with more proportion of patients achieving HbA1c <7% over time.