Introduction

Type 2 diabetes mellitus (T2DM) is no longer a standalone metabolic disorder. It is associated with the “ominous octet”: hepatic glucose overproduction, insulin resistance, β-cell dysfunction, lipolysis, glucagon excess, renal glucose reabsorption, and altered neurotransmitter regulation. The combination of dipeptidyl peptidase-4 inhibitors (DPP-4i) and sodium-glucose cotransporter-2 inhibitors (SGLT2i) is potentially effective in managing T2DM as it addresses at least six of the eight elements of the “ominous octet”.

Aim

To determine the efficacy, safety, and practice patterns of the fixed-dose combination (FDC) of vildagliptin 100 mg and dapagliflozin 10 mg in cardiology practice.

Patient Profile

Methods

Study Design

Treatment Strategy

Outcomes

• The number and percentage of patients overall, and of various age groups receiving the FDC of vildagliptin 100 mg and dapagliflozin 10 mg
• The duration of FDC of vildagliptin 100 mg and dapagliflozin 10 mg therapy
• The duration of comorbidities
• Compliance to FDC of vildagliptin 100 mg and dapagliflozin 10 mg therapy
• Incidence of adverse events (AEs) reported in last 1-year related to FDC therapy
• Efficacy and safety parameters including quality of life (adherence and lack of side effects)

Results

• The study population comprised of 2,199 patients (mean age: 55.04 years, males: 62.62%). Approximately, 62.94% of patients were in the age group of 40–60 years and 27.47% patients were in the age group 60–80 years. 
• The mean duration of treatment with the FDC of vildagliptin 100 mg and dapagliflozin 10 mg was 8.07 months. The most common comorbidity seen in the study population was hypertension (74.81%, mean duration: 44.85 months), followed by dyslipidemia (38.52%, mean duration: 40.49 months), coronary artery disease (CAD, 14.60%), and stroke/transient ischemic attack (TIA, 5.23%). 
• The mean glycosylated hemoglobin (HbA1c) decreased significantly from baseline to 3 months (Fig. 1; values represented as mean ±SD)

Fig. 1: Change in HbA1c from baseline to 3 months

                

Fig. 2: Change in FPG and PPG from baseline to 3 months

 

 

Fig. 3: Physicians’ global assessment

1. Evaluation of tolerability
2. Evaluation of efficacy

 

• The mean SBP (±SD) decreased from 141.35 (± 12.60) mmHg to 131.59 (± 10.38) mmHg, and the mean DBP decreased from 89.65 (±7.37) mmHg to 84.42 (±5.78) mmHg from baseline to 3 months with the FDC therapy.
• Of the entire study population, 78.08% patients achieved their glycemic goal with the FDC of vildagliptin 100 mg and dapagliflozin 10 mg.
• The FDC was well tolerated with a low incidence of AEs. 
• Overall, treatment adherence-related issues were noted in 29.15% patients, mainly due to lack of exercise (14.46%), followed by dietary non-compliance (13.42%), and failure to follow home-based glucose monitoring as advised (11.51%), other reasons included not taking the medication on time, parameters being uncontrolled with existing medicines and laziness.

Conclusions

• Diabetes management must extend beyond glycemic control to address cardiovascular risk. Early intervention for patients with T2DM and comorbidities like hypertension and dyslipidemia is essential to prevent vascular complications. 
• Fixed-dose combinations offer a multifaceted approach: vildagliptin 100 mg plus dapagliflozin 10 mg demonstrated significant improvements in HbA1c and blood pressure, with good tolerability and low AEs rates. 
• These findings support the utility of this FDC in real-world Indian practice, highlighting its role in optimizing both glycemic and cardiovascular parameters while simplifying therapy and improving adherence.

Medical Res Arch. 2025; 13 (5): DOI:10.18103/mra.v13i6.4449.