Glycemic effects of vildagliptin and metformin combination therapy in Indian patients with type 2 diabetes: an observational study.

BACKGROUND: To analyze the glycemic response of Indian patients with type2 diabetes mellitus (T2DM) to combination therapy with vildagliptin and metformin and compare our data with those of clinical trials. METHODS: In a retrospective study of the hospital database, the glycemic control of 280 patients with T2DM who were either on a once- or twice-daily regimen of combination therapy with vildagliptin 50 mg and metformin 500 mg was analyzed. RESULTS: The mean duration of follow-up of the patients was 16.8 months. There was a reduction in fasting plasma glucose (FPG) of 1.52 +/- 0.79 and 1.88 +/- 0.87 mmol/L in the once- and twice-daily groups, respectively (both P < 0.0001) from baseline to last visit. The reduction in postprandial plasma glucose (PPPG) in the once- and twice-daily groups was 3.98 +/- 1.72 and 4.33 +/- 1.88 mmol/L, respectively (both P < 0.0001), whereas the reduction in HbA1c was 1.41 +/- 1.39% and 1.90 +/- 1.49%, respectively (both P < 0.0001). The differences in the reductions achieved in FPG and HbA1c with the two dosing regimens were significant. CONCLUSION: Although the present retrospective study shows a robust response to the combination of vildagliptin and metformin in Indian patients, more multicenter studies from India with a greater number patients are necessary to confirm this finding......