Introduction: GUARD (vildaGliptin clinical Use in reAl woRlD) was a multinational, prospective, observational study that assessed the effectiveness, safety and tolerability of vildagliptin and vildagliptin+metformin in patients with type 2 diabetes mellitus (T2DM) under real-world conditions across four geographical regions (Asia, the Middle East, Central America and Africa). The current paper discusses the results of patients with T2DM enrolled in the Philippines.

Methods: Patients with T2DM who were prescribed vildagliptin or vildagliptin+metformin combination therapy were enrolled and followed as per routine clinical practice for 24 ± six weeks. Primary endpoint was the change in HbA1c from baseline to study end (week 24±6). Key secondary endpoints included proportion of patients reaching target HbA1c ≤7.0%, incidence of hypoglycemic events, adverse events (AEs) and serious AEs (SAEs).

Results: A total of 1,117 patients were included in the final analysis, 280 on vildagliptin (of these, eight patients received additional oral antidiabetes medications) and 837 on vildagliptin+metformin. At baseline, the mean (±SD) age of the enrolled population was 54.1±11.5 years, BMI 26.3±4.7 kg/m2, HbA1c 8.0±1.2% and T2DM duration 2.3±4.0 years. At study end, significant mean (±SE) reductions in HbA1c of -1.2±0.1% (p<0.0001) and -1.5±0.1% (p<0.0001) from a baseline of 7.6±1.1% and 8.1±1.2% were observed for the vildagliptin and vildagliptin+metformin group, respectively. A similar proportion of patients achieved HbA1c ≤7.0% in the vildagliptin (66.1%) and vildagliptin+metformin group (62.7%). Changes in body weight and BMI from baseline to week 24±6 were statistically significant (p<0.0001) in both the vildagliptin (-1.5±0.3 kg; -0.6±0.1 kg/m2) and the vildagliptin+metformin group (-1.4±0.2 kg; -0.5±0.1 kg/ m2). The incidence of hypoglycemia was low—six patients reported hypoglycemia in the vildagliptin+metformin group and none in the vildagliptin group. Incidence of adverse events was also low in both the groups (vildagliptin, 8.6% and vildagliptin+metformin, 5.3%).

Conclusion: Vildagliptin and vildagliptin+metformin significantly reduced HbA1c with good weight control and low incidence of hypoglycemia in patients with T2DM under real-world conditions in Philippines.

Key words: real-world, vildagliptin, type 2 diabetes mellitus, Philippines  

1. International Diabetes Federation. IDF Diabetes Atlas, 6th ed. Brussels, Belgium: International Diabetes Federation; 2015. Available from: http://www.diabetesatlas.org/resources/2015- atlas.html. Accessed July 21, 2016
2. Jimeno CA, Sobrepeña LM, Mirasol R. DiabCare 2008: Survey on glycaemic control and the status of diabetes care and complications among patients with type 2 diabetes mellitus in the Philippines. Phil J Intern Med. 50:15–22, 2012.
3. Cade WT. Diabetes-related microvascular and macrovascular diseases in the physical therapy setting. Phys Ther. 88:1322–55, 2008.
4. Stratton MA, Adler AL, Neil HA, et al. Association of glycaemia with microvascular and macrovascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ. 321:405‒12, 2000.
5. Philippine practice guidelines for the diagnosis and management of diabetes – a project of Unite for Diabetes Philippines: a coalition of organizations caring for individuals with diabetes mellitus. 5PPD Compendium of Philippine Medicine 16th ed. 2014. Available from: http://endo-society.org.ph/publications/ clinical-practice-guidelines/. Accessed July 21, 2016
6. Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycaemia in type 2 diabetes, 2015: a patient-centred approach. Update to a Position Statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetologia. 58:429–42, 2015.
7. International Diabetes Federation. Global guideline for type 2 diabetes. Diabetes Res Clin Pract. 104;1–52, 2014.
8. Goldman-Levine JD. Beyond metformin: initiating combination therapy in patients with type 2 diabetes mellitus. Pharmacotherapy. 3:44S–53S, 2011.
9. Garber AJ, Abrahamson MJ, Barcilay JI, et al. AACE comprehensive diabetes management algorithm 2013: task force. Endocr Pract. 19:327–336, 2013.
10. Ahrén B, Schweizer A, Dejager S, et al. Mechanism of action of the dipeptidyl-peptidase-4 inhibitor vildagliptin in humans. Diabetes Obes Metab. 13:775–83, 2011.
11. Schweizer A, Couturier A, Foley JE, Dejager S. Comparison between vildagliptin and metformin to sustain reductions in HbA(1c) over 1 year in drug-naive patients with Type 2 diabetes. Diabet Med. 24:955–961, 2007.
12. Bosi E, Dotta F, Jia Y, et al. Vildagliptin plus metformin combination therapy provides superior glycaemic control to individual monotherapy in treatment-naive patients with type 2 diabetes mellitus. Diabetes Obes Metab. 11:506–15, 2009.
13. Blüher M, Kurz I, Dannenmaier S, et al. Efficacy and safety of vildagliptin in clinical practice-results of the PROVIL-study. World J Diabetes. 3:161–9, 2012.
14. Treweek S, Zwarenstein M. Making trials matter: pragmatic and explanatory trials and the problem of applicability. Trials. 10:37, 2009.
15.  Rosales R, Abou Jaoude E, Al-Arouj M, et al. Clinical effectiveness and safety of vildagliptin in >19,000 patients with type 2 diabetes: the GUARD study. Diabetes Obes Metab. 17:603–7, 2015.
16. Gatbonton P, Santos GKDL, Domingo F, et al. Effectiveness and Tolerability of Vildagliptin Versus Other Oral Antidiabetic Drugs in Patients with Type 2 Diabetes Mellitus in the Philippines: Results from One Year Observational Study (EDGE). Phil J Intern Med. 51:1–6, 2013.
17. Strain WD, Cos X, Hirst M, et al. Time to do more: Addressing clinical inertia in the management of type 2 diabetes mellitus; Diabetes Res Clin Pract. 105:302–12, 2014.
18. Ahrén B, Mathieu C, Bader G, et al. Efficacy of vildagliptin versus sulfonylureas as add-on therapy to metformin: comparison of results from randomised controlled and observational studies. Diabetologia. 57:1304–7, 2014.