Effectiveness and Tolerability of Vildagliptin plus Metformin Compared with Other Oral Dual Antidiabetes Agents in Different Baseline BMI Patients with Type 2 Diabetes—A Real-World Study (China PDS)

Background and Aim: The real-world study of China PDS with 2083 type 2 diabetes mellitus (T2DM) patients showed that vildagliptin plus metformin (VM) therapy could effectively control the HbA1c with good tolerability. Here, we present the results of baseline BMI subgroups.

Materials and Methods:In China PDS, T2DM patients with poor glycemic control on monotherapy were assigned to either VM dual therapy or other oral dual agents(OD) therapy according to local physician’s decision. For this analysis, patients were divided into three subgroups according tobaseline BMI(<24kg/m², 24-28kg/m², >28kg/m²). The primary outcome was the proportion of patients with HbA1c<7% and without tolerability events(hypoglycemia, weight gain, or discontinuation due to gastrointestinal event) at 12^th month. Secondary outcomes included mean changes in HbA1c from baseline to study endpoint and tolerability.

Results:In total, 389(149 in VM vs. 240 in OD) patients in BMI<24kg/m² group, 625(304 in VM vs. 321 in OD) patients in BMI 24-28kg/m² group, and 260(151 in VM vs. 109 in OD) patients in BMI>28kg/m² group were enrolled. Compared with OD, significantly higher proportion patients reached primary outcome in VM in BMI<24kg/m² group (47.0% vs. 35.0%; P=0.019), in BMI 24-28kg/m² group (52.6% vs. 33.3%; P<0.001), and in BMI>28kg/m² group (51.0% vs. 33.9%; P=0.006). Mean HbA1c changes were significantly greater in VM than in OD(BMI<24kg/m²: -1.23% vs. -0.76%; BMI 24-28kg/m²: -1.32% vs. -0.79%; BMI>28kg/m²: -1.29% vs. -0.84%; P<0.for all). VM resulted in less tolerability findings than OD in BMI<24kg/m² (11.4% vs. 19.2) and BMI 24-28kg/m² (3.6% vs. 14.6%) groups (P<0.for both), but not in BMI >28kg/m² group (4.6% vs. 5.5%, P>0.05).

Conclusion:In different baseline BMI groups, vildagliptin plus metformin dual therapy was associated with better glycemic control and was well tolerated compared with OD.