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

Novartis has announced that the European Commission has approved the use of Galvus® (vildagliptin) in people with type 2 diabetes unable to control their blood sugar with diet and exercise alone and who cannot take metformin, the current standard of care.1,2

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

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: (accessed 07.02.2012).
4. International Diabetes Federation (2012) Types of diabetes. Available at: (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)

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