Isis Pharma Reports ISIS-GCGRRx Phase 2 Results - Quick Facts

(RTTNews) - Isis Pharmaceuticals, Inc. (ISIS) announced the final results from its Phase 2 study of ISIS-GCGRRx in patients with type 2 diabetes uncontrolled on stable metformin therapy.

The Phase 2 study was a double-blinded, randomized, placebo-controlled study in 75 patients with type 2 diabetes who had uncontrolled blood sugar despite treatment with stable metformin therapy. In the study, patients in the per protocol population, or PP, treated with ISIS-GCGRRx in addition to metformin achieved absolute mean reduction in hemoglobin A1c (HbA1c) of up to 2.25 percentage points from baseline after only 13 weeks of treatment. Patients receiving placebo had an 0.25 percentage point reduction in HbA1c. More than half of the PP patients achieved an HbA1c level of less than or equal to 7.0 percent. PP patients treated with ISIS-GCGRRx in this study also achieved a mean reduction of up to 74.9 µmol/L in fructosamine. In addition, in these patients a mean increase in total GLP-1 of up to 19.97 pmol/L was observed. ISIS-GCGRRx was generally well tolerated in the study, Isis said.

The company said, given the robust glucose lowering observed, it plans to conduct additional studies to identify the optimal dose and schedule to achieve glucose control with manageable glucagon receptor-related liver enzyme elevations.