Isis Pharmaceuticals announced results from its Phase 2 study of ISIS-GCGRRX in patients with type 2 diabetes uncontrolled on stable metformin therapy at the 2014 American Diabetes Association Scientific Sessions. ISIS-GCGRRx is designed to act through a distinct mechanism to improve insulin sensitivity and/or reduce glucose production in patients with type 2 diabetes.
This double-blinded, placebo-controlled study randomized 75 patients with type 2 diabetes to either 100mg or 200mg of ISIS-GCGRRx or placebo for 13 weeks added to their stable doses of metformin. Patients in the 100mg cohort received a loading dose of three 100mg doses within the first seven days of the study and a weekly 100mg dose every week thereafter for 12 weeks. Patients in the 200mg cohort received either a loading dose of three 200mg doses within the first seven days of the study and a weekly 200mg dose every week thereafter for 12 weeks or a weekly dose of 200mg every week for 13 weeks.
After 13 weeks of dosing, statistically significant mean reductions in HbA1c were achieved in patients treated at both doses. Patients in the per protocol population (PP) treated with ISIS-GCGRRx 200mg with a loading dose in addition to metformin achieved absolute mean reduction in hemoglobin A1c (HbA1c) of up to 2.25 percentage points from baseline after 13 weeks of treatment compared to placebo (P≤0.001). Patients receiving placebo had an 0.25 percentage point reduction in HbA1c. In this study, more than half of the PP patients achieved an HbA1c level of ≤7.0%.
Glucose control, including serum fructosamine and fasting plasma glucose levels were also significantly reduced in patients treated with ISIS-GCGRRx. The observed improvement in glucose control was in addition to that achieved with each patient’s existing therapeutic regimen of metformin.
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