Metabasis Therapeutics Inc has completed a Phase 2A trial on its first-in-class oral gluconeogenesis inhibitor in patients with type 2 diabetes mellitus (diabetes). The results of the trial provide the first evidence that this new class of drugs is capable of significantly reducing blood glucose levels in patients with diabetes. Metabasis' partner on the project since 1997, Sankyo Co., Ltd., is funding and directing the clinical development of the drug.
In preclinical studies, CS-917 reduced the overproduction of the sugar called glucose by the liver and thereby lowered blood glucose levels. Patients with type 2 diabetes have chronically elevated blood glucose levels and consequently often suffer from severe complications, including heart disease, stroke, blindness, peripheral vascular disease, kidney disease and nerve damage.
The recently completed Phase 2A study was designed to provide evidence that the drug lowered glucose levels in humans. In a randomized, placebo controlled, double blind trial, patients with type 2 diabetes received the drug orally one time daily for a period of fourteen days. Results from this initial study appear promising in that CS-917-treated patients exhibited lower blood glucose levels for the first six hours after dosing on day 14 compared to glucose levels on the day before the first dose was administered.
Moreover, glucose lowering was greater in CS-917-treated patients relative to placebo-treated patients. Additional studies are planned for later this year and next year to confirm these results and determine a safe and effective dosing regimen.
According to the American Diabetes Association, as of 2002 approximately 17 million people in the United States had diabetes. Approximately 90-95% of Americans who are diagnosed with diabetes have type 2 diabetes. The number of new cases of diabetes is rising rapidly. Approximately 900,000 people aged 20 years and older will be diagnosed with type 2 diabetes this year. Diabetes is the fifth-leading cause of death by disease in the United States.