The randomized, placebo controlled, double blind phase IIb study is designed to evaluate the effectiveness of CS-917 in lowering blood glucose levels in patients with type 2 diabetes.
The drug’s efficacy will be evaluated by measuring levels of hemogloblin A1c (HbA1c), an accurate long-term index of a patient’s average blood glucose control. Results of the phase IIb study will be used to select the appropriate dosage of CS-917 for use in phase III clinical trials.
CS-917, the first in a new class of investigational drugs called fructose 1-6 bisphosphatase inhibitors (FBPase), appears to inhibit a metabolic pathway in the liver called gluconeogenesis, which is responsible for the excessive production of glucose by patients with type 2 diabetes. Previous phase IIa studies have demonstrated promising results in lowering blood glucose levels.
“We are very pleased with the progress we are making with CS-917,” said Dr Paul Laikind, chairman, CEO and president of Metabasis. “Two previously completed studies provided important proof of concept for the program and the study now underway, if successful, will allow us to move the compound into phase III trials.”
Sankyo licensed CS-917 from Metabasis and is responsible for the global development of the compound.