Galvus® approved for monotherapy use in people with type 2 diabetes unable to take metformin

Approval is based on data from clinical studies in more than 3000 patients, which have assessed the efficacy and tolerability of vildagliptin as monotherapy.² In these studies, vildagliptin delivered significant improvements in glycaemic control and was shown to be generally well-tolerated.² Vildagliptin was demonstrated to be weight neutral and to be associated with a very low risk of hypoglycaemia.²

There are more than 47 million people with type 2 diabetes in Europe and this figure is projected to rise to 57 million by 2030.^3,4 A quarter of patients with type 2 diabetes being treated cannot take metformin due to intolerance or contraindications, including those with renal impairment.^5,6

References
1. Senior PA (2012) Type 2 diabetes, metformin and lactic acidosis – defining the risk and promoting safe practice. Diabet Med 29: 161−3
2. Novartis data on file
3. International Diabetes Federation (2012) Diabetes Atlas Fifth Edition: Europe (EUR). Available at: http://www.idf.org/diabetesatlas/5e/europe (accessed 07.02.2012).
4. International Diabetes Federation (2012) Types of diabetes. Available at: http://www.idf.org/types-diabetes (accessed 07.02.2012).
5. Blicklé JF et al (2007) Diabetic nephropathy in the elderly. Diabetes Metab 33(suppl 1): S40−55
6. Metformin Summary of Product Characteristics (SmPC)