Comparison of Safety and Efficacy of Glimepiride-Metformin and Vildagliptin- Metformin Treatment in Newly Diagnosed Type 2 Diabetic Patients.

OBJECTIVE

To compare the safety and efficacy of glimepiride and vildagliptin as add-on therapy to metformin in newly diagnosed patients with type 2 diabetes mellitus (T2DM).

METHODS

This 24-week, prospective, comparative, observational study was conducted among newly diagnosed patients with T2DM. The primary endpoint was a change in fasting plasma glucose (FPG), postpradinal glucose (PPG), and HbA1c from the baseline to week 24. The key secondary endpoints were monitoring treatment-emergent adverse events such as hypoglycemia, overall gastrointestinal symptoms and weight gain, and electrocardiogram (ECG) findings.

RESULTS

A total of 100 eligible patients were divided into two groups: group A ( = 50) received vildagliptin plus metformin and group B ( = 50) received glimepiride plus metformin. The mean age of the patients was 49.98 years and 52.12 years in group A and group B, respectively. Electrocardiographic findings were within normal limits in all the patients from group A, whereas 47 patients from group B showed normal ECG findings. A significant decrease in HbA1c, fasting and post-prandial plasma glucose was observed with group A and group B from the baseline to week-24. However, at week-24, reduction in HbA1c and blood glucose parameters were comparable between the groups. Safety outcomes did not show any events of hypoglycemia with vildagliptin. Mild hypoglycemia was reported with glimepiride in five patients.

CONCLUSION

Vildagliptin-metformin appeared to be equally effective to glimepiride-metformin in reducing HbA1c level and blood glucose parameters, however, resulted in better adverse event profiles with lower risks of hypoglycemia.