Effectiveness, safety, and tolerability of vildagliptin or vildagliptin/metformin combination in patients with type 2 diabetes uncontrolled on insulin therapy in a real-world setting in Egypt: The OMEGA study.

PURPOSE

To evaluate the effectiveness and safety of vildagliptin or vildagliptin/metformin combination among patients with type 2 diabetes mellitus (T2DM) uncontrolled on insulin in a real-world setting in Egypt.

METHODS

This 12-week, prospective, observational study enrolled T2DM patients. Primary endpoint was mean change in glycated hemoglobin (HbA1c) from baseline to Week 12. Secondary endpoints included mean change in body weight, insulin dosage and safety after 12 weeks.

RESULTS

Of the 90 patients enrolled, 88 (93.6%) completed the study. The mean age was 54.7 years; men, 51.1%; body mass index (BMI), 31.6 kg/m; T2DM duration, 89.8 months; insulin dose, 55.14 IU/day. At 12 weeks, HbA1c decreased significantly with vildagliptin/metformin (-1.3 ± 0.9%, p < 0.0001) and vildagliptin (-1.1 ± 0.9%, p = 0.0001). 27.1% and 11.1% achieved HbA1c <7% in vildagliptin/metformin and vildagliptin groups, respectively. Significant mean (±standard deviation [SD]) reduction in body weight (-2.5 ± 7.3 kg, p = 0.0055) and insulin dose (-24.11 ± 22.3 IU, p < 0.0001) was observed in the vildagliptin/metformin group. Overall, 8 (8.9%) patients reported 11 (12.2%) adverse events (AEs) and no hypoglycemic events. AEs possibly related to the study drug (4.2%, in vildagliptin/metformin) were mild in severity.

CONCLUSION

Vildagliptin with/without metformin as an add-on to insulin resulted in good glycemic control and was well tolerated without any hypoglycemic events.