Evidence map›Paper›PMID 40390755›Full record

ArticleCureus2025

Efficacy and Safety of Vildagliptin Sustained-Release and Metformin Sustained-Release Fixed-Dose Combination in Indian Patients With Type 2 Diabetes Mellitus: A Real-World Perspective.

Archana Sarda, Bhavana Sosale, Balaji Jagan Mohan, Snehal Tanna, Vipul Gupta, Sanjay Gupta, Deepak Langade, Rahul Kotwal, Vivek Kolapkar, Kamlesh Patel

Abstract read
In one paragraph

Article in Cureus, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Archana SardaDepartment of Diabetology, Sarda Centre For Diabetes and Selfcare, Chhatrapati Sambhaji Nagar, IND.
Bhavana SosaleDepartment of Diabetology, Diacon Hospital, Retina Institute of Karnataka, Bengaluru, IND.
Balaji Jagan MohanDepartment of Diabetology, Apollo Sugar Clinic, Bengaluru, IND.
Snehal TannaDepartment of Diabetology, Jupiter Hospital, Thane, IND.
Vipul GuptaDepartment of Diabetology, Gupta Ultrasound and Heart Care Centre, New Delhi, IND.
Sanjay GuptaDepartment of Diabetology, S.G. Diabetes Centre, Delhi, IND.
Deepak LangadePharmacology, D. Y. Patil University School of Medicine, Navi Mumbai, IND.
Rahul KotwalDepartment of Medical Affairs, Lupin Limited, Mumbai, IND.
Vivek KolapkarDepartment of Medical Affairs, Lupin Limited, Mumbai, IND.
Kamlesh PatelDepartment of Medical Affairs, Lupin Limited, Mumbai, IND.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Introduction The efficacy of vildagliptin as an add-on to metformin has been demonstrated in type 2 diabetes mellitus (T2DM) patients inadequately controlled on metformin monotherapy, as well as in early combination therapy for newly diagnosed T2DM patients. However, there is limited evidence on the efficacy and safety of a fixed-dose combination (FDC) of vildagliptin sustained-release (SR) and metformin SR in these patient groups. This study evaluated the efficacy and safety of an FDC of vildagliptin SR and metformin SR in patients with T2DM in real-world clinical settings across India. Methods A retrospective, multicenter, post-marketing study was conducted. Data from T2DM patients across 95 centers in India were collected and analyzed retrospectively. The study included adults (18-65 years) diagnosed with T2DM who were either newly diagnosed or inadequately controlled on existing therapy and were prescribed vildagliptin SR 100 mg and metformin SR 500/1000 mg FDC at the discretion of their treating physician. Primary outcomes assessed were reductions in HbA1c (%), fasting plasma glucose (FPG), and postprandial plasma glucose (PPG) from baseline to day 90. Results Data from 1,090 patients were included for analysis. The mean age of the patients was 54.46 years, and the mean baseline HbA1c was 8.19 ± 1.22%. The FDC of vildagliptin 100 mg SR and metformin 500 mg SR was prescribed to 89.26% of patients, while the FDC of vildagliptin 100 mg SR and metformin 1000 mg SR was prescribed to 10.73%. The overall study population showed a reduction of -0.81 ± 1.00% in HbA1c (p < 0.0001). Significant reductions in FPG of -28.61 ± 35.15 mg/dL (p < 0.0001) and in PPG of -42.32 ± 52.19 mg/dL (p < 0.0001) were observed. No serious adverse events were reported during the study. Conclusion The FDC of vildagliptin SR and metformin SR was effective, safe, and well-tolerated for managing T2DM in patients who were either newly diagnosed or inadequately controlled on other antidiabetic agents in Indian real-world settings.

Indexed as

early combinationfixed-dose combinationglycemic controltreatment-naïvevildagliptin sr

Identifiers

PMID40390755
PMCPMC12086291

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.