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Ocera Therapeutics, Inc. Message Board

  • occams.laser occams.laser Jun 9, 2012 2:07 AM Flag

    72nd Diabetes Sci Sessions 6/8-12/2012


    TZYM going on downtown, driving the TZP102 highway !

    Session: Managing the Complications of Diabetes
    Abstract Number: 951-P

    Title: TZP-102 Ghrelin Receptor Agonist Improves Symptoms of Diabetic Gastroparesis in Both Type 1 and Type 2 Diabetes
    Presentation Start: 6/11/2012 1:00:00 PM
    Presentation End: 6/11/2012 2:00:00 PM

    Authors: NIELS EJSKJAER, RAYAZ A. MALIK, LISE TARNOW, PER HELLSTROM, GEORG DIMCEVSKI, JC PEZULLO, ROBERT VENUTI, LAURA SHAUGHNESSY, PHILIPPA CHARLTON, GORDANA KOSUTIC, RICHARD MCCALLUM, Aarhus, Denmark, Manchester, United Kingdom, Gentofte, Denmark, Stockholm, Sweden, Bergen, Norway, Washington DC, WA, Durham, NC, Texas, TX.

    Abstract: Hypothesis: TZP-102 ghrelin receptor agonist reduces symptoms of diabetic gastroparesis in both type 1 and type 2 diabetes.
    Objectives: To characterize TZP-102 effects on symptoms of gastroparesis in type 1 and type 2 diabetes.
    Methodology: Patients with diabetes, delayed GE, and moderate/severe upper gastrointestinal symptoms were randomized to 10, 20 or 40mg TZP-102 or placebo. Symptoms were evaluated by patient-reported symptom severity scales (0-5) on days 8, 15, 28 (treatment) and 42, 58 (follow up).

    Findings: 92 patients {females 65%; age 49.9 ± 11.9 years; 91% Caucasian; BMI 28.8 ± 5.1; 60% type 1; ~70% on insulin; HbA1c 8.3 ± 1.5%; PAGI-SYM 3.0 ± 0.8; breath test t1/2 GE 193 ± 51 min} received treatment (22, 21, 23 and 26 patients received 10, 20, 40 mg TZP-102 and placebo, respectively). Significant improvements vs. placebo were observed in individual symptoms across all TZP-102 dose groups. However, the maximum improvement was achieved at the 20mg dose, with no additional benefit seen at the 40mg dose.

    Importantly, statistically significant improvement vs. placebo was observed with 20mg TZP-102 for each of the most prevalent symptoms for this patient population, and the magnitude of the effects was similar in type 1 and type 2 diabetic patients (see below).

    TZP-102 End of Treatment Change from Baseline over Placebo* in Prevalent (>90% of Patients) Symptoms of Gastroparesis - 20mg Dose
    Symptom All patients (n=21) p-value Type 1 (n=10) Type 2 (n=11)
    Nausea -1.0 0.029 -1.0 -0.9
    Early satiety -0.9 0.022 -0.9 -1.2
    Postprandial fullness -1.0 0.019 -1.4 -0.4
    Bloating-stomach large -0.9 0.018 -0.9 -0.8
    Upper abdominal pain -0.7 0.042 -0.7 -0.7

    *Placebo n=26; type 1 =15; type 2=11
    Conclusion: TZP-102 significantly improves symptoms of gastroparesis in both type 1 and type 2 diabetic patients.

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