Effect of Sitagliptin Versus Glibenclamide on Glycemic Markers, Lipid Profile Inflammatory and Oxidative Stress Factors in Type 2 Diabetes Patients: a Double-Blinded Randomized Controlled Trial.

ABSTRACT

Objectives:Diabetes mellitus is leading to chronic complications, including cardiovascular diseases. The aim of this study was to compare the effect of Sitagliptin and Glibenclamide on glycemic markers, lipid profile inflammatory, and oxidative stress factors in type 2 diabetes patients. Methods: This double-blinded randomized controlled trial was performed on patients with type 2 diabetes mellitus (n=54). The treatment group (27 patients) received 100 mg of Sitagliptin once daily + 500 mg Metformin twice daily, orally, for 12 weeks, and the control group (27 patients) was given 5 mg of Glibenclamide once daily + 500 mg Metformin twice daily, also orally, for 12 weeks. Serum levels of tumor necrosis factor alpha (TNF-α), high-sensitivity C-reactive protein (hs-CRP), interleukin-6 (IL-6), lipid profile [cholesterol, low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C), triglyceride (TG)], fasting blood sugar (FBS) and hemoglobin A1C (HbA1c), body weight, and body mass index (BMI) were measured before and after the study. Results:In both groups, the FBS level was significantly reduced from baseline (P=0.03 in the Sitagliptin group and P=0.02 in the Glibenclamide one). The percent of HbA1c was also significantly reduced from baseline in both the Sitagliptin group (P=0.01) and the Glibenclamide one (P=0.008). However, comparing the groups, these changes were not different. In the Sitagliptin group, IL-6 was significantly reduced from baseline (P=0.01) as well as in comparison with the Glibenclamide group (P=0.001). The TG level was significantly lower than the baseline in the Sitagliptin group (P=0.03), so changes between groups were significant (P=0.04). Weight and BMI were significantly increased from baseline in the Glibenclamide group (P=0.02 and P=0.03, respectively), and their changes between the two groups were also significant (P=0.001). Conclusion:These finding support the favorable effects of Sitagliptin on cardiovascular risks beyond its advantages on insulin-glucose hemostasis in patients with type 2 diabetes.