BioCentury
ARTICLE | Clinical News

ISIS-GCGRRx: Phase II final data

August 11, 2014 7:00 AM UTC

Final data from 62 patients in the per protocol (PP) population of a double-blind, U.S. and South African Phase II trial in 75 Type II diabetics uncontrolled on stable metformin therapy showed that once-weekly ISIS-GCGRRx plus metformin significantly reduced mean absolute HbA1c from baseline to week 14 by 1.35 percentage points in the 100 mg arm (p<=0.001), by 2.25 percentage points in the 200 mg loaded arm (p<=0.001) and by 1.74 percentage points in the 200 mg non-loaded arm (p<=0.01) vs. 0.25 percentage points for placebo. The loaded arm comprised patients who received at least 11 doses of 200 mg ISIS-GCGRRx within 70 days, while the non-loaded arm comprised patients who received 12 doses of 200 mg ISIS-GCGRRx within 87 days.

Additionally, ISIS-GCGRRx significantly reduced serum fructosamine levels from baseline to week 14 by 62.3 Umol/L in the 100 mg arm (p<=0.001), by 74.9 Umol/L in the 200 mg loaded arm (p<=0.001) and by 72.2 Umol/L in the 200 mg non-loaded arm (p<=0.01) vs. 7.6 Umol/L for placebo. ISIS-GCGRRx also significantly reduced FPG from baseline to week 14 by 9.13 pmol/L in the 100 mg arm, by 19.89 pmol/L in the 200 mg loaded arm and by 19.97 pmol/L in the 200 mg non-loaded arm vs. 0.05 pmol/L for placebo (p<=0.001 for all). ...