San Diego-based Elcelyx Therapeutics has completed a 12-week Phase 2b study of NewMet, a delayed-release formulation of metformin for the treatment of patients with type 2 diabetes.
Elcelyx previously reported that the study met its primary endpoint of statistically significant reduction in fasting plasma glucose at four weeks of treatment with NewMet compared to placebo. The 12-week data confirm the durability of the effect observed at four weeks.
The randomized, 240-patient, multicenter, double-blind, dose-finding trial evaluated NewMet once-daily doses of 1,000, 800 and 600 milligrams compared to placebo. There were also two un-blinded reference arms with Glucophage XR dosed once-daily at 1,000 and 2,000 milligrams.
All NewMet arms showed efficacy comparable to or greater than 1,000 milligrams of Glucophage XR. The NewMet 1,000 milligram dose was approximately 50 percent more effective than 1,000 milligrams of Glucophage XR and approximately 70 percent as effective as 2,000 milligrams of Glucophage XR.
A dose response trend was observed across the three NewMet doses, indicating higher doses of NewMet may provide greater efficacy.