Comparison of efficacy and safety of vildagliptin 50 mg tablet twice daily and vildagliptin 100 mg sustained release once daily tablet on top of metformin in Indian patients with Type 2 diabetes mellitus: A randomized, open label, Phase IV parallel group, clinical trial

ABSTRACT

Background: Type 2 diabetes mellitus (DM) is mainly due to multifactorial of which insulin resistance and deficiency in the incretion are two important pathophysiological factors. Vildagliptin, an oral hypoglycemic agent, acts by inhibiting dipeptidyl peptidase-4 enzyme, often uses as a first line drug along with metformin to enhance outcome. Aim and Objective: The aim of this study was to compare the effectiveness and safety of vildagliptin 50 mg twice daily dose with vildagliptin 100 mg sustained release tablet (SR) once daily in Type 2 DM patients and uncontrolled with metformin monotherapy. Materials and Methods: Adult patients with Type 2 DM fulfilling the inclusion criteria were randomized in two groups. Group 1 patient received metformin 1000 mg/day in two divided dose and tablet vildagliptin 50 mg 2 times daily, while Group 2 patients received metformin 1000 mg/day in two divided dose along with vildagliptin 100 mg SR once daily. Fasting plasma glucose (FPG), postprandial plasma glucose (PPPG), and glycated hemoglobin (HbA1C), were measured at baseline, on week 4, week 8, and week 12 visits. Liver function test (SGOT), SGPT, Serum Bilirubin), kidney function test electrolytes, serum urea, serum creatinine), and body weight also measured in first visit and in 12th week. Results: HbA1C, FPG, and PPPG all three decreased equally at 12 week from their respective baseline values (P < 0.05) in both groups. There is no statistically significant alteration of liver enzymes and in serum bilirubin level from baseline to 12th week in both groups. Conclusion: Vildagliptin 100 mg SR once daily dose is equally effective and safe as 50 mg twice daily dose in terms of reducing HbA1C, FPG, and PPPG when it is used along with metformin 1000 mg.