InteKrin Therapeutics announced results from its Phase 2b study of INT131 for the treatment of type 2 diabetes. This trial (INT131-007) was a 366 patient 24 week double blind study comparing 4 doses of INT131 to maximal dose Actos (pioglitazone HCl, from Takeda) or placebo in patients with poorly controlled type 2 diabetes mellitus (DM) on stable dose sulfonylurea with or without metformin.
Lower extremity edema was assessed with a predefined scoring tool designed for maximal sensitivity for pitting edema at baseline, 12, and 24 weeks. 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.
INT131 is a next-generation insulin sensitizer that addresses insulin resistance, a key etiological feature in the onset and subsequent progression of type 2 diabetes. As a selective PPAR-gamma modulator (SPPARM), INT131 has been designed to provide potent glucose lowering and durability of effect without the recognized side effects of the currently available insulin sensitizers which, unlike INT131, are full PPAR-gamma agonists.
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