Ref: Ibrahim El Ebrashy, 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, Diabetes Res Clin Pract.2020 Apr; 162:108042.  doi: 10.1016/j.diabres.2020.108042.

Objective:

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.

Study Design:

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

Results:

• Significant reduction in HbA1c by Vildagliptin and Vildagliptin/metformin treatment group was observed at week 12.               ( Figure-1)

Figure1

• 27.1% of the patients achieved HbA1c <7% in Vildagliptin / metformin and 11.1% in Vildagliptin group at week 12 ( Figure-2)

Figure2

• Decrease in body weight of patients at week 12 in both Vildagliptin / metformin (p=0.0055) groups was noted  ( Figure 3)

Figure3

• A significant reduction in the daily insulin dose was observed in the Vildagliptin / metformin group (p<0.0001) (Figure-4)

Figure4

• A significant decrease in FPG and PPG was observed in both the groups

FPG (Fasting Plasma Glucose):

• Vildagliptin: 52.7 ± 62.3 mg/dL (p=.0023)
• Vildagliptin / metformin: 51.43 ± 41.7 mg/dL (p=.0001)

PPG (Postprandial Glucose):

• Vildagliptin:  73.3 ± 91.3 mg/dL (p=.0034)   
• Vildagliptin / metformin: 81.82 ± 59.7 mg/dL (p<.0001)

• No serious adverse events were observed throughout the study

Conclusion

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