LOS ALTOS, Calif., June 29 /PRNewswire/ -- InteKrin Therapeutics presented 6 month Phase 2b clinical data for edema in diabetic patients showing differentiation for INT131, a Selective PPAR-gamma Modulator (SPPARM), from Actos® (pioglitazone), yesterday at the American Diabetes Association annual meeting in Orlando, FL.
INT131 besylate (INT131) is a novel, non-TZD, selective oral PPAR-gamma modulator (SPPARM) designed to improve glucose metabolism while minimizing the side effects of the TZD full PPAR-gamma agonists such as Actos®: fluid retention (edema), CHF, bone fracture, and weight gain. The Phase 2b trial, INT131-007, was a 366 patient 24 wk double blind study comparing 4 doses of INT131 to maximal dose Actos® (pioglitazone) or placebo in patients with poorly controlled T2DM on stable dose sulfonylurea (SU) with or without metformin (met). Lower extremity edema was assessed with a predefined scoring tool designed for maximal sensitivity for pitting edema at baseline, 12, and 24 wks. Results show INT131 improved glycemic control as measured by HbA1c comparable to Actos® but without evidence of any significant change in edema compared to baseline or placebo. Substantial edema was noted in the pioglitazone group, consistent with published data. These findings support the SPPARM function of INT131 and suggest it represents a safer insulin sensitizer.
"This data clearly differentiates INT131 besylate from pioglitazone with respect to the important clinical parameter of edema," remarked Dr. Alex DePaoli, Acting Chief Medical Officer of InteKrin Therapeutics, who presented the data. "These findings are consistent with previous clinical data and support the advantages of the SPPARM nature of this agent."
|SOURCE InteKrin Therapeutics|
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