The impact of three combinations vildagliptin/metformin, vildagliptin/pioglitazone, and metformin/pioglitazone on glycemic control and atherogenic dyslipidemia in patients with Type 2 diabetes mellitus.

ABSTRACT

Background: There are limitations of currently recommended stepwise treatment for Type 2 diabetes, especially failure with monotherapies to achieve the strict glycemic control. This has prompted the intensification of therapy with such combinations which have additive efficacy and complimentary mechanisms of action. Vildagliptin is one such agent with the above potential which does not increase the risk of hypoglycemia and does not promote weight gain. Methods: It was a prospective, open-label, randomized, and parallel group study involving 90 patients, divided into three Groups A, B, and C. Group A given vildagliptin/metformin (50/500 mg), Group B vildagliptin/pioglitazone (50/15 mg)and Group C metformin/pioglitazone (500/15 mg) combinations twice daily for 12 weeks. Fasting blood glucose (FBG) was estimated biweekly while hemoglobin A1c (HbA1c), lipid profile, insulin, and C-peptide levels at 0 and 12th week. Statistical analysis was done using ANOVA and Student’s t-test. Results: At the end, mean percentage of age fall in HbA1c and FBG from baseline was maximum in Group B, which was found out to be more efficacious than Group A and C (p<0.001) on glycemic parameters. Mean percentage of age decrease in triglyceride from baseline was maximum in Group C, which was found out to be more efficacious than Group A and B (p<0.001) on lipid parameters. The adverse effects were low in all the groups. However, the incidence of peripheral edema and weight gain was more with the use of Group C while nausea, vomiting, and nasopharyngitis was more with the use of Group A. Conclusion: Vildagliptin/pioglitazone combination is of choice in patients with uncontrolled hyperglycemia but normal lipid profile while metformin/pioglitazone combination in diabetic patients with dyslipidemia.