ITCA 650: Final Phase II data

Final data from an open-label, U.S. Phase II trial in 155 Type II diabetics on stable metformin showed that 20, 40, 60 and 80 µg/day ITCA 650 implanted subcutaneously reduced mean HbA1c from baseline to week 24 by 0.89%, 0.86%, 1.38% and 1.36%, respectively (p<0.001 for all relative to baseline). Additionally, the proportion of patients receiving each escalating dose of ITCA 650 that achieved HbA1c <=7% was 60%, 71%, 73% and 79%, respectively. Mean reductions in weight from baseline to week 24 for 20, 40, 60 and 80 µg/day ITCA 650 were 1.8, 7.9, 6.8 and 7.7 lbs, respectively.

Patients initially received 20 or 40 µg/day ITCA 650 or Byetta exenatide for 12 weeks. At week 12, patients receiving ITCA 650 were re-randomized to either continue on the same dose or escalate to 60 or 80 µg ITCA 650 for weeks 13-24, while patients receiving Byetta were switched to 40 or 60 µg/day ITCA 650 for 12 weeks. Data were presented at the European Association for the Study of Diabetes meeting in Stockholm. ...