Novartis said Nov. 28 that a two-year study showed its highly touted DPP-4 inhibitor, Galvus, was not as effective as the older diabetes drug metformin, but the company expressed confidence that Galvus still would be approved by the U.S. Food and Drug Administration in the first half of 2007.

The latest data submitted to U.S. regulators, who earlier this month put action on Galvus on hold for three-months to resolve a variety of issues, showed that Galvus lowered blood sugar levels in the HbA1c test by 1.1 percent in diabetic patients starting treatment, while metformin lowered sugar levels 1.5 percent.

However, Galvus had ``significantly better tolerability'' that metformin, James Shannon, Novartis head of pharmaceutical development, told reporters.

A treatment that lowers blood sugar by more than one percent is seen as ``very potent'', Shannon said. He said Novartis does not intend to market Galvus as a replacement for metformin, but rather as a drug that can be used by patients who do not like the older drug.

Galvus is one of a new class of drugs that enhance the body's ability to lower blood sugar. Merck & Co. last month received FDA approval for its DPP-IV drug, Januvia, giving it what now seems likely to be at least a six-month head start on Galvus.

Shannon also said Novartis intends to seek regulatory approval for a combination of Galvus and older diabetes drug metformin. Merck has filed a similar application for FDA approval of a combination of Januvia with metformin.