Novartis announced the start of Galiant, a significant clinical trial set to involve more than 7,500 people in the United States comparing the investigational oral type 2 diabetes medication Galvus (vildagliptin) with commonly prescribed anti-diabetic oral medicines called thiazolidinediones (TZDs).
Clinical trials to date have demonstrated that treatment with Galvus results in consistent, significant and sustained reductions in blood sugar levels, leading to improved glucose control. The need for new therapies is urgent given that diabetes currently affects about 230 million people worldwide and is estimated to grow to more than 350 million by 2025, according to the International Diabetes Federation.
Galiant is a three-month multi-centre trial that plans to enrol more than 7,500 patients at 800 research centres throughout the US. The study will be conducted in a "real world" setting involving predominantly primary care physicians.
The Galiant study is expected to build on trial results presented earlier this year that showed patients receiving Galvus as monotherapy experienced similar and significant reductions in blood sugar levels to those treated with the TZD rosiglitazone.
"Doctors across the country and the world are caring for more and more people with poorly controlled type 2 diabetes," said Richard E Pratley, MD, Professor of Medicine, Director, Diabetes and Metabolism Translational Medicine Unit, University of Vermont and a principal investigator of the Galiant study.
"There is a great need to get people to their target blood sugar. To do this, we need effective treatments that don't increase the risk for hypoglycaemia or low blood sugar. The Galiant trial, with its focus on the primary care setting, will provide us with a full range of results that can be applied to many different types of people with diabetes and help determine the potential role the DPP-4 inhibitor, Galvus, may play in the treatment of type 2 diabetes," Dr Pratley said.
The Galiant study, which is a three-month multi-centre, randomised, open-label, active-controlled trial, will compare the efficacy and safety of Galvus (100 mg once-daily) directly against insulin sensitizers, also known as TZDs, in people with type 2 diabetes already receiving metformin, but not at their target blood sugar goals. Importantly, this study will also assess the impact of Galvus on many different patient populations, including the elderly, different ethnic groups, and patients with varying degrees of body mass index (BMI).
"The Galiant trial is yet another illustration of the robust development program that supports Galvus, and our commitment to innovative research that began when Novartis pioneered the investigation of DPP-4 inhibition as a diabetes treatment target," said James Shannon, MD, Head of Development at Novartis Pharma AG. "With the prevalence of type 2 diabetes escalating in countries around the globe, Novartis is fully committed to and engaged with the world's leading diabetes physicians and researchers who are dedicated to improving treatment options for people with type 2 diabetes."
Galvus works through a novel mechanism of action targeting the pancreatic islet dysfunction that causes high blood sugar levels in people with type 2 diabetes. Specifically, islet dysfunction can lead to excess sugar production (via glucagon from the alpha-cells) and reduced insulin production (from the beta-cells).
In clinical studies, Galvus has demonstrated significant reductions in blood sugar sustained at one year. Galvus is suitable for once-daily dosing and has been evaluated both as monotherapy and in combination with other anti-diabetes agents. Galvus also improved the pancreatic alpha and beta cells' ability to appropriately sense and respond to sugar in the blood. Galvus is not associated with weight gain in the overall patient population, a key benefit for people with diabetes who struggle to keep their weight under control. The overall incidence of side effects with Galvus including hypoglycemia (excessively low blood sugar) and edema (fluid retention) was similar to placebo in monotherapy trials. The most common side effects seen in the Galvus clinical program were cold/flu-like symptoms, headaches and dizziness.
Both the US Food and Drug Administration and European Union regulatory agencies are reviewing applications seeking approval of Galvus to treat patients with type 2 diabetes. Regulatory action from the FDA is expected by the end of 2006.