Vildagliptin-Dapagliflozin FDC Effective in High CV Risk Indian T2DM Patients: Findings from Latest DAa-ViNCI Study

In a new study, fixed-dose combination (FDC) of vildagliptin and dapagliflozin demonstrated substantial efficacy and good tolerability in managing Type 2 Diabetes Mellitus (T2DM).

The recent study titled, "DApagliflozin 10 mg and Vildagliptin 100 mg SR use in Cardiology Practice: A real world Clinical Insight (DAa-ViNCI Study)," was published in May 2025 in the Medical Research Archives -Journal of the European Society of Medicine.

The study aimed to assess the early initiation of vildagliptin and dapagliflozin FDC's efficacy, safety, and tolerability in real-world cardiology practice, with ethical approval obtained.

The study was a retrospective, non-randomized, non-comparative investigation conducted across 200 cardiology centers in India. It included 2199 T2DM patients with a mean age of 55 years. The patients were prescribed the FDC of vildagliptin 100 mg SR and dapagliflozin 10 mg. Comprehensive patient information, including demographics, treatment duration, comorbidities, and adverse events, was gathered.

The study included T2D patients with high CV risk with a spectrum of about 10 various cardio-metabolic co-morbidities.

Among the study participants, hypertension was the most prevalent comorbidity (74.81%), followed by dyslipidemia (38.52%), coronary artery disease (14.60%), stroke/transient ischemic attack (5.23%), non-alcoholic fatty liver disease (4.32%), retinopathy (3.50%), nephropathy (3.14%), foot ulcer (1.50%), erectile dysfunction (0.73%), peripheral artery disease (0.64%) and others (1.22%).

The following are the study end points:

- Glycemic endpoints included changes in glycated hemoglobin (HbA1c), fasting plasma glucose (FPG), postprandial glucose (PPG), and achievement of glycemic goals.

- Blood pressure efficacy was evaluated through changes in mean systolic (SBP) and diastolic (DBP) readings.

Additional efficacy and safety parameters included quality of life (adherence and absence of side effects) and adverse events related to FDC therapy in the past year.

The study also examined FDC usage patterns, including the number and percentage of patients on FDC across age groups, therapy duration, comorbidity duration, and treatment compliance.

Key findings from the study are:

Clinical Efficacy

• Glycemic control improved substantially over three months. HbA1c decreased from 7.7% (SD 3.10) to 5.8% (SD 2.88) leading to a reduction of 1.9%, fasting plasma glucose (FPG) dropped from 142.4 mg/dL (SD 88.4) to 90.2 mg/dL (SD 62.44), resulting in a reduction of 52.2mg/dl and postprandial glucose (PPG) reduced from 205.64 mg/dL (SD 128) to 123.38 mg/dL (SD 89.15), causing a reduction of 82.3mg/dl at 3 months. (Table 1)

• Out of 2199, 1717 patients (78.08%) achieved their glycemic goal.

• Mean systolic blood pressure (SBP) reduced from 141.35 mmHg to 131.59 mmHg resulting in a reduction of 10mmHg, and mean diastolic blood pressure (DBP) dropped from 89.65 mmHg to 84.42 mmHg leading to a reduction of 5mmHg.

Physician Assessment, Adherence & Safety

• According to the physicians' global assessment, 73.35% of physicians observed good efficacy. Additionally, 73.81 reported good tolerability of the FDC.

• No patients discontinued the therapy due to adverse effects, indicating good tolerability of the combination.

• Adverse events were minimal, reported in only 0.36% of patients, with urinary tract infection being the most common at 0.13%.

The DAa-ViNCI Study provides real-world evidence that the vildagliptin/dapagliflozin FDC is an effective and well-tolerated option for managing T2DM, particularly in Indian cardiology practice. By significantly improving glycemic control and lowering blood pressure with a low incidence of adverse events, the combination supports better cardiovascular health and overall patient outcomes in routine clinical settings.

T2DM is a major global health challenge. Patients with T2DM often present with early cardiovascular risk factors such as hypertension and dyslipidemia, making these patients more prone to progressive vascular damage.

Effective T2DM management requires addressing both blood sugar and cardiovascular risks, and the fixed-dose combination of vildagliptin and dapagliflozin offers a synergistic solution by improving glycemic control and reducing blood pressure and weight.

The study highlights the clinical importance of early initiation of Vildagliptin - Dapagliflozin FDC in T2DM patients with cardiovascular risk, supporting durable glycemic control as well as cardiovascular risk prevention.

Reference: Kaur, M., Kalra, T., Kumar, M., Bansal, A., Avasthi, A., & Thakur, S. (2025). An In Vitro Study to Examine the Comparative Accuracy and Stability of Elastomeric Impression Materials under Different Levels of Hydration. Dental Journal of Advance Studies, 13(1), 1-7.