Vildagliptin Shows Advantages Over Existing Diabetes Therapies

Improves bloods sugars, cholesterol and has the potential to prevent pre-diabetic patients developing Type 2 diabetes along with cardiovascular and metabolic complications of the disease.

Newly-released Phase III data for vildagliptin, the first of a new class of oral antidiabetic drugs known as dipeptidyl peptidase-IV (DPP-IV) inhibitors, show the drug improves on currently available therapeutic options in several respects. Available data show vildagliptin avoids the GI side effects of metformin, it avoids the weight-gain seen with thiazolidinediones, and it cuts insulin requirements by around half.

DPP-IV inhibitors also known as incretin enhancers work by helping maintain levels of the incretin hormone glucagon-like-peptide (GLP-1) which augments insulin secretion following meals but which is deficient in pre-diabetes and Type 2 diabetes. The DPP-IV enzyme normally rapidly degrades GLP-1 so that additional insulin secretion is not prolonged more than necessary. DPP-IV inhibitors therefore are designed for use in diabetic or pre-diabetic subjects with reduced levels of GLP-1 to allow the hormone to function much more effectively over a longer period. The effect also protects pancreatic beta cells from over-stimulation and, ultimately, failure to produce sufficient insulin. Novartis, Merck and Bristol-Myers Squibb all have DPP-IV inhibitors in development.

Data presented, showed how vildagliptin is performing clinically in large studies. Previously-reported smaller Phase II studies have shown vildagliptin reduces HbA1c, improves insulin sensitivity and sustains insulin levels suggesting improvement in beta-cell function. Pre-clinical studies have shown the drug increases beta-cell mass.

In a 780-patient Phase III trial comparing it against the European gold standard treatment for Type 2 diabetes, metformin, vildapgliptin was better tolerated than metformin whilst achieving similar sustained reductions in HbA1c over one year.

From baseline HbA1c levels of 8.7%, vildagliptin-treated patients reduced HbA1c to 7.56% compared to 7.40% for metformin. However, metformin-treated patients experienced more than four times as much diarrhoea (26% vs 6%) and more than three times as much nausea (10% vs 3%) as vildagliptin-treated patients. Both treatments were weight-neutral.

In a further 296-patient Phase III study comparing vildagliptin against placebo in patients requiring insulin therapy, vildagliptin 100mg tdd plus insulin significantly reduced HbA1c by 0.51% compared to a reduction of 0.24% by placebo plus insulin. Vildagliptin almost halved patients’ insulin requirements compared to placebo 2.64 vs 4.97IU whilst avoiding grade 2 hypoglycaemic incidents (0 vs 6).

The company says it plans to present further pivotal clinical data in 2006. It also claims to have an extensive “islet protection” research program in place. It hopes this will demonstrate by 2009 how islet protection via vildagliptin treatment can prevent Type 2 diabetes developing in patients at risk and can slow progression of disease and maintain control in patients who already have Type 2 disease. In addition, Novartis says by 2011 it expects to show how treatment reduces adverse cardiovascular and metabolic outcomes.

Commenting on vildagliptin during the recent European Association for the Study of Diabetes meeting, Bo Ahren, Professor of Metabolic Research at Lund University said: “This drug is as important in terms of clinical practice as sulphonylureas and insulin were when they were introduced. It is the first drug that really has a chance of reversing the main defect in diabetes – the malfunctioning islet cells. Insulin is just a replacement therapy and sulphonylureas stimulate insulin secretion. But vildagliptin will actually improve the health of the islets. We need long term studies, of course, but if these confirm what we are seeing now, it really will be a breakthrough in diabetes.”

Novartis plans to file vildagliptin for approval in the US in 2006. It will be submitted to the European regulatory authority in 2007.

Novartis research and development meeting for analysts on 20th September

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