The phase 2 study enrolled 155 type 2 diabetes patients (51-53 patients/arm) across 50 centers in the United States who were on a stable treatment regimen of metformin. The study compared six different regimens to find the optimal dose range and regimen to take into phase 3.
Study Design and Summary of Week 48 ResultsAfter an initial 12-week treatment period comparing ITCA 650 20 mcg/day and 40 mcg/day with twice-daily injections of exenatide based on pre-study re-randomization, patients received continued treatment with one of 4 doses of ITCA 650: 20, 40, 60 or 80 mcg/day in the following manner through the planned 24-week endpoint:Treatment Weeks 1 – 12Treatment Weeks 13 - 48ITCA 650 20 mcg/day - - -
ITCA 650 20 mcg/dayITCA 650 20 mcg/day - - -
ITCA 650 60 mcg/dayITCA 650 40 mcg/day - - -
ITCA 650 40 mcg/dayITCA 650 40 mcg/day - - -
ITCA 650 80 mcg/dayExenatide BID injection - - -
ITCA 650 40 mcg/dayExenatide BID injection - - -
ITCA 650 60 mcg/dayAfter the completion of the 24-week study, clinical sites were authorized to offer patients an extension of up to an additional 24 weeks of treatment to evaluate longer term safety and glycemic control. Thirty-five of the original 50 sites were able to participate in the extension study and a total of 86 patients (85% of those eligible from these sites) entered the extension study.
Continued reductions in HbA1c, FPG and weight were observed across all treatment arms at week 48 compared to week 24. Both incremental and aggregate reductions in HbA1c were greatest in the 60 mcg/day and 80 mcg/day dose arms but not measurably different between these two dose arms.
ITCA 650 dose weeks 13 –48
|SOURCE Intarcia Therapeutics, Inc.|
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