INT131-007 is a 24 week, high dose active comparator (45mg Actos) and placebo controlled study of INT131 at four doses in poorly controlled type 2 diabetics.
According to InteKrin, INT131 is a selective peroxisome proliferator-activated receptor (PPAR) gamma modulator which has consistently demonstrated the separation of the powerful PPAR gamma anti-diabetic efficacy from the well recognized thiazolidinedione (TZD) side effects.
Denny Lanfear, president and CEO of InteKrin, said: “InteKrin is very pleased to achieve this critical development milestone for INT131. We anticipate having results from INT131-007 in the second half of 2009 concurrent with completion of all nonclinical and CMC efforts, enabling initiation of the INT131 Phase III program in 1H2010.”