Intarcia Therapeutics, Inc. Presents ITCA 650 Phase 1b Study Results as a Late-Breaker at the American Diabetes Association 69th Scientifi...(n via a single insertion of ITCA 650. ....)

    Fasting & Postprandial Glucose             ITCA 650 Dose Arms
                                             (continuous daily dose)
                                       10        20        40        80
                                     mcg/day   mcg/day   mcg/day   mcg/day
    Mean FPG at baseline (mg/dL)      161.2     170.5     171.8     145.1
    Mean FPG at end of treatment
     (mg/dL)                          155.6     139.4     129.8     116.3
    Change from baseline (mg/dL)       -5.6     -31.1     -42.0     -28.8
    Change in 2-hr PPG at end of
     treatment (mg/dL)                 -8.8     -32.3     -47.1     -74.6

Substantial decreases in FPG and PPG were observed throughout treatment. Decreases in FPG were evident within 24 hours of the initiation of treatment suggesting a rapid and consistent achievement of desired exenatide levels with DUROS delivery. Changes in PPG measured at days 15 and 29 also showed consistent dose-dependent reductions.

    HbA1c & Body Weight                        ITCA 650 Dose Arms
                                             (continuous daily dose)
                                       10        20        40        80
                                     mcg/day   mcg/day   mcg/day   mcg/day
    % HbA1c at baseline               7.67      7.90      7.45      7.38
    % HbA1c at end of treatment       7.15      7.28      7.00      6.80
    Change from baseline             -0.52     -0.62     -0.45     -0.58
    Mean change in weight (kg)       -0.28     -0.31     -0.93     -2.91

Although the treatment duration in the study was only 28 days, decreases in HbA1c and body weight were observed across all dose arms. The most commonly reported adverse events were nausea and vomiting which were mostly mild, transient and dose dependent.

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