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ARTICLE | Clinical News

Remogliflozin etabonate: Phase IIb data

April 21, 2014 7:00 AM UTC

BHV and Islet Sciences Inc. (OTCBB:ISLT, New York, N.Y.) reported data from a pair of double-blind, dose-ranging, placebo- and pioglitazone-controlled Phase IIb trials in 563 treatment-naïve patients with Type II diabetes showing that all doses of once- and twice-daily remogliflozin met the primary endpoint of reducing HbA1c from baseline to week 12 vs. placebo. Additionally, in the first trial (n=322), all doses of twice-daily remogliflozin produced a significant trend in reducing HbA1c from baseline to week 12 (reductions of 1-1.4%, p<0.001 for the dose response). In the second trial (n=241), once-daily remogliflozin at doses above the lowest dose tested produced a significant trend in reducing HbA1c from baseline to week 12 (reductions of 0.5-0.8%, p<0.047 for the dose response).

All doses of once- and twice-daily remogliflozin met the secondary endpoint of reducing FPG from baseline to week 12 vs. placebo. Additionally, twice-daily remogliflozin led to significant reductions in body weight of 1.36-3.51 kg from baseline to week 12 vs. placebo, while once-daily remogliflozin at doses above the lowest dose tested led to significant reductions of 1.44-1.51 kg on the endpoint vs. placebo. Remogliflozin was well tolerated. Data from both trials will be presented at the American Diabetes Association meeting in San Francisco in June. ...