GUARD was a multinational, prospective, non-interventional study evaluating the clinical effectiveness, safety and tolerability of vildagliptin or vildagliptin + metformin as part of routine care for 24 weeks in adult patients with type 2 diabetes mellitus (T2DM) (drug-naive or treated with an oral antidiabetic [OAD] agent). Patients were enrolled from countries in Asia, the Middle East, Central America and Africa. Primary endpoint: change in HbA1c from baseline until Week 24; secondary assessments: proportion of patients reaching HbA1c ≤7.0%; change in body weight and BMI from baseline; and safety (including hypoglycaemic events).
Of 19,331 patients analysed (mean baseline age 48.8 years, weight 78.1 kg, BMI 28.3 kg/m2, and HbA1c 8.40%), 3,511 received vildagliptin (the majority monotherapy, a small proportion [n=73] received other OADs) and 15,820 received vildagliptin + metformin. At study end, mean HbA1c was reduced significantly from baseline by –1.27% overall (vildagliptin: –1.17%; vildagliptin + metformin: –1.29%, p<0.0001). Overall, 43.6% of patients reached the HbA1c ≤7.0% (vildagliptin: 47.2%; vildagliptin + metformin: 42.8%). Weight and BMI changes from baseline were –1.1 kg and –0.4 kg/m2 with vildagliptin and –1.5 kg and –0.5 kg/m2 with vildagliptin + metformin, respectively (p<0.0001 for weight and BMI). Treatment with vildagliptin was generally well tolerated. Adverse events (AEs) were reported in 699 (3.6%) patients overall (vildagliptin: 143 [4.1%]; vildagliptin + metformin: 556 [3.5%]). Most frequently reported AEs were hypoglycaemia, nausea and diarrhoea, occurring similarly in both vildagliptin treatment groups. Serious AEs occurred in 22 patients (0.1%) overall, of which 4 were suspected as being related to the medication of interest. No cases of pancreatitis or pancreatic cancer were reported.
In this real world study, vildagliptin +/- metformin provided statistically significant and clinically relevant glycaemic control with weight control and was well tolerated in a large multiethnic patient population with T2DM.
Funded by Novartis Pharma AG (including medical writing assistance)