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Intarcia Presents Positive ITCA 650 Phase 2 Study Results for Type 2 Diabetes at EASD
Date:9/22/2010

per year."

The phase 2 study enrolled 155 type 2 diabetes patients (51-53 patients/arm) across 50 centers in the United States 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:

  • ITCA 650 20 mcg/day for 24 weeks
  • ITCA 650 40 mcg/day for 24 weeks
  • ITCA 650 20 mcg/day for weeks 1 -12 followed by ITCA 650 60 mcg/day for weeks 13 -24
  • ITCA 650 40 mcg/day for weeks 1 -12 followed by ITCA 650 80 mcg/day for weeks 13 -24
  • Exenatide injection for weeks 1 -12 followed by ITCA 650 40 mcg/day for weeks 13 -24
  • Exenatide injection for weeks 1 -12 followed by ITCA 650 60 mcg/day for weeks 13 -24

  • Summary of week 12 resultsTreatment with ITCA 650 at doses of 20 mcg/day and 40 mcg/day resulted in significant reductions in HbA1c at week 12.  Initiating treatment with ITCA 650 20 mcg/day resulted in less frequent and less persistent nausea compared with ITCA 650 40 mcg/day and exenatide injection.  Nausea rates among patients receiving ITCA 650 at 40 mcg/day were similar to those receiving twice-daily injection of exenatide at 10 mcg BID.

    The phase 2 study also incorporated a quality of life (QOL) assessment (DM-SAT) completed by each patient prior to initiating treatment, at treatment week 8 and again at treatment week 20.  The results of week 8 assessment suggest that patients receiving either dose of ITCA 650 experienced significantly greater improvement in their quality of life compared to patients receiving twice-daily injections of exenatide.

    Summary of week 12 resultsTreatment Arms
    Weeks 1 – 12

    ITCA 650 20 mcg/d

    ITCA 650 40 mcg/dExenatide InjectionMean baseline HbA1c (%)

    7.90

    8.00

    8.01Mean week 12 HbA1c (%)

    6.94

    6.96

    7.19Mean change

    -0.96*

    -1.04*

    -0.82*Nausea ratesweek 1

    25%

    37%'/>"/>

    SOURCE Intarcia Therapeutics, Inc.
    Copyright©2010 PR Newswire.
    All rights reserved

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