Comparison of Vildagliptin and Pioglitazone in Korean Patients with Type 2 Diabetes Inadequately Controlled with Metformin

Abstract

Background: We compared the efficacies of vildagliptin (50 mg twice daily) relative to pioglitazone (15 mg once daily) as an add-on treatment to metformin for reducing glycosylated hemoglobin (HbA1c) levels in Korean patients with type 2 diabetes.

Methods: The present study was a multicenter, randomized, active-controlled investigation comparing the effects of vildagliptin and pioglitazone in Korean patients receiving a stable dose of metformin but exhibiting inadequate glycemic control. Each patient underwent a 16-week treatment period with either vildagliptin or pioglitazone as an add-on treatment to metformin.

Results: The mean changes in HbA1c levels from baseline were -0.94% in the vildagliptin group and -0.6% in the pioglitazone group and the difference between the treatments was below the non-inferiority margin of 0.3%. The mean changes in postprandial plasma glucose (PPG) levels were -60.2 mg/dL in the vildagliptin group and -38.2 mg/dL in the pioglitazone group and these values significantly differed (P=0.040). There were significant decreases in the levels of total, low density lipoprotein, high density lipoprotein (HDL), and non-HDL cholesterol in the vildagliptin group but increases in the pioglitazone group. The mean change in body weight was -0.07 kg in the vildagliptin group and 0.69 kg in the pioglitazone group, which were also significantly different (P=0.002).

Conclusion: As an add-on to metformin, the efficacy of vildagliptin for the improvement of glycemic control is not inferior to that of pioglitazone in Korean patients with type 2 diabetes. In addition, add-on treatment with vildagliptin had beneficial effects on PPG levels, lipid profiles, and body weight compared to pioglitazone.

Keywords: Dipeptidyl peptidase 4 inhibitor; Metformin; Thiazolidinediones.

Fig. 1. (A) Study design. (B) Patient disposition. bid, twice daily; qd, once daily; FBG, fasting blood glucose.

Fig. 2. (A) Change in glycosylated hemoglobin (HbA1c) from baseline at 16 weeks. Time-course of mean HbA1c (B), mean fasting plasma glucose (FPG) (C), mean postprandial glucose (D), and mean body weight (E) during 16-week treatment with vildagliptin (closed triangles) or pioglitazone (closed circles) in patients with type 2 diabetes continuing their previous stable metformin dose regimen. Values are presented as mean±standard error. bid, twice daily; qd, once daily.