80 mcg/dayMean baseline HbA1c (%)
7.9Mean week 48 HbA1c (%)
6.5Mean HbA1c change at week 48
1.4Mean weight change at week 48 (lbs)
-7.9Based on the consistent results observed at the week 24 study endpoint and the week 48 extension, a starting dose of ITCA 650 20 mcg/day for weeks 1 – 12 followed by transition to ITCA 650 60 mcg/day appears to provide the most substantial incremental reductions in HbA1c, FPG and body weight with the most favorable tolerability profile.
Throughout the extended treatment duration of the study, there were no treatment discontinuations due to nausea. Numeric improvements were observed in measures of BP and lipids at weeks 24 and 48 compared to baseline.
"Testing novel therapies over longer treatment durations is very important to confirm sustained efficacy effects, safety and tolerability," said Julio Rosenstock, MD, ITCA 650 phase 2 study principal investigator. These encouraging findings warrant further investigation of the optimized dose regimen of ITCA 650 20 - 60 mcg/day in large phase 3 studies and using longer duration devices."
Patient Satisfaction SurveyA treatment satisfaction questionnaire was administered to patients before the study and at study weeks 8 and 20. Results of the week 8 assessment suggested a higher level of satisfaction among patients receiving ITCA 650 20 mcg/day or ITCA 650 40 mcg/day compared with patients self-injecting exenatide twice daily. Results of the week 20 assessment showed a substantial improvement in treatment satisfaction among patients switching from exenatide injection to ITCA 650 and that the substantial improvement observed among patients initially randomized to ITCA 650 was maintained after transition to higher doses of ITCA 650.
|SOURCE Intarcia Therapeutics, Inc.|
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