GUARD was a 24-week prospective, multinational study, which assessed the effectiveness and safety of vildagliptin or vildagliptin + metformin as part of routine care in adult patients with type 2 diabetes mellitus (T2DM) (drug-naive or treated with an oral antidiabetic [OAD] agent). Patients were recruited from Asia, the Middle East, Central America and Africa. This analysis assessed change in HbA1c from baseline to study end according to baseline HbA1c, obesity status and age.
Of 19,331 patients analysed, 3,511 patients received vildagliptin (the majority monotherapy, a small proportion [n=73] received other OADs) and 15,820 received vildagliptin + metformin. At baseline, 5,120 (26.5%) were obese (BMI ≥30 kg/m2) and 1,238 patients (6.4%) aged ≥65 years. Baseline HbA1c categories: ≤8% (N=6,407); >8–9% (N=8,765); >9–10% (N=3,239); and >10% (N=358). Significant reductions (overall: –0.83% to –3.28%) in mean HbA1c from baseline to study end were reported across all baseline HbA1c subgroups (p<0.0001), with greater decreases in patients with higher baseline HbA1c. Generally consistent and significant mean HbA1c reductions from baseline were observed across different patients sub-groups, overall: non-obese (–1.24%), obese (–1.39%); age <65 years (–1.27%) and age ≥65 years (–1.31%); and split by vildagliptin or vildagliptin + metformin: non-obese (vildagliptin: –1.16%, vildagliptin + metformin: –1.26%), obese (vildagliptin: –1.27%, vildagliptin + metformin: –1.41%), age <65 years (vildagliptin: –1.17%, vildagliptin + metformin: –1.29%) and age ≥65 years (vildagliptin –1.11%, vildagliptin + metformin –1.35%) (p<0.0001). Vildagliptin treatment +/- metformin was generally well tolerated, with adverse events reported in 3.6% of patients overall.
Vildagliptin treatment +/- metformin provided consistent, clinically effective glycaemic control, regardless of baseline HbA1c, obesity status and age, and was well tolerated in a large multiethnic patient population with T2DM studied in routine clinical practice.
Funded by Novartis Pharma AG (including medical writing assistance)