Swiss drug major Novartis has started a large-scale clinical trial programme that will compare its investigational oral type 2 diabetes medication Galvus (vildagliptin) with commonly-prescribed antidiabetics called thiazolidinediones, also known as glitazones.
The three-month, multicentre GALIANT trial plans to enroll more than 7,500 people at 800 research centers throughout the USA and will be conducted in a real-world setting involving predominantly primary care physicians.
Novartis noted that 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.
But with both Galvus and rival Januvia (sitagliptin) both set to win US approval in the next few weeks, the stage already seems set for rapid take-up of the new agents, which could put pressure on established thiazolidinediones such as GlaxoSmithKline’s Avandia (rosiglitazone) and Takeda and Eli Lilly’s Actos (pioglitazone).
A survey of 60 endocrinologists and other physicians involved in the management of diabetics, carried out by Reuters Primary Research, has indicated that more than 90% intend to make use of the new drugs, and 70% would consider switching patients on older drugs to them.
Both drugs are DPP-4 inhibitors, which are designed to enhance the body's ability to lower elevated blood sugar. Clinical results to date suggest they are less likely to cause side effects.
In particular the DPP-4 inhibitors are not associated with the weight gain often seen on treatment with other drugs, such as sulfonylureas, which can be a major problem for diabetics.
According to the International Diabetes Federation, the need for new therapies is urgent as diabetes currently affects 230 million people worldwide and this is estimated to reach more than 350 million by 2025, Novartis noted.