Although the treatment duration in the study was only 28 days, decreases in HbA1c and body weight were observed across all dose arms. Changes in HbA1c from baseline were statistically significant across all treatment arms. The most commonly reported adverse events were nausea and vomiting which were mostly mild, transient, dose dependent and limited to the first week of therapy.
"We've been very pleased with the positive results of this study and rapid progress in the ITCA 650 development program," said K. Alice Leung, President and CEO of Intarcia. "Within just 4 months of completing the phase 1b study, Intarcia began enrollment of an ongoing phase 2 study comparing ITCA 650 with twice-daily Byetta® (exenatide) injection among 150 patients with type 2 diabetes over a 3-month treatment period."
The phase 2 trial will evaluate ITCA 650 against the current standard of care for a longer duration of treatment and among a larger population of type 2 diabetes patients. The goals of the ITCA 650 program are to enhance the therapeutic effects of exenatide by ensuring patient compliance and providing more consistent, around-the-clock therapeutic drug levels, and to reduce side effects, including nausea associated with high peak levels of exenatide exposure observed with
|SOURCE Intarcia Therapeutics, Inc.|
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