Novartis is initiating a large-scale, head-to-head Phase IIIb clinical trial comparing its investigational type 2 diabetes drug Galvus (vildagliptin) to thiazolidinediones, the company announced Oct. 11.

The trial could potentially result in the modification of type 2 diabetes treatment standards, according to the company. The study is designed to show that 100 mg Galvus once daily is as effective as TZDs in improving blood sugar control in a primary care setting.

An NDA for Galvus, a dipeptidyl peptidase IV inhibitor, is currently pending at FDA with a November user fee date. Novartis submitted the application in March (¹ Also see "Novartis' Galvus NDA Follows Close On The Heels Of Merck's Januvia" - Pink Sheet, 30 March, 2006.).

The three-month randomized, open-label, active-controlled, multi-center study called GALIANT will enroll 7,500 patients with type 2 diabetes already receiving metformin but who have not reached their target blood sugar goals.

The study will take place at 800 U.S. sites in a "real world" setting involving mostly primary care physicians, Novartis said.

Novartis VP-U.S. Clinical Development & Medical Affairs for Cardiovascular and Metabolic Diseases Marjorie Gatlin told "The Pink Sheet" DAILY, "The exciting thing about this trial is that...the physicians will use the TZD of their choice in the way they normally use it in practice."

"It really allows us to have a real world comparison of [Galvus versus TZDs], and it is powered to allow a robust assessment of efficacy in key patient subgroups based on race, obesity and age," she said.

Novartis has already presented trial results showing patients receiving Galvus as a monotherapy experienced blood sugar reductions similar to those treated with the TZD rosiglitazone.

Novartis is in a race with Merck to bring to market the first DPP-IV inhibitor. Merck stands a chance of being first. Its NDA for Januvia (sitagliptin) has a user fee date later this month (² Also see "Novartis Seeks European Approval For Galvus" - Pink Sheet, 17 August, 2006.).

Novartis is also in the midst of a trial called GLORIOUS, investigating the potential for using Galvus as a preventative diabetes treatment.

GLORIOUS is "designed to look at individuals who have pre-diabetes and see if we can delay or prevent their conversion or progression from pre-diabetes to frank diabetes, and also to look at patients who have diabetes to see if we can delay or prevent the progression," Gatlin said.

FDA is developing a draft guidance to articulate a regulatory pathway to help expedite development of diabetes prevention therapies (³ Also see "Diabetes Prevention Drugs Will Be Addressed In FDA Guidance" - Pink Sheet, 11 August, 2006.).

- Daniel Fowler (d.fowler@elsevier.com)

Galvus Trial May Show Potential For Modifying Type 2 Diabetes Treatment Guidelines

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