ORAL DOSES OF ABT-229 FOR POSTPRANDIAL DIGESTIVE SYMPTOMS/INSULI RQRNG DIABETES

ABT-229是一种具有胃动素激动剂活性但无明显抗菌素活性的大环内酯类新药。运动药物治疗糖尿病胃轻瘫取得了一定的成功。ABT-229有可能在不改变正常肠道菌群的情况下改变糖尿病胃轻瘫患者的病理生理和改善症状。这项研究的目的是评估四种不同剂量的ABT-229与安慰剂相比治疗餐后消化症状的疗效，并评估ABT-229在需要胰岛素的糖尿病患者中的安全性。患者将被要求在研究期间避免使用其他促动力和抗分泌剂。在每次就诊时，患者将进行实验室测试、怀孕测试(对有生育潜力的女性)、药代动力学血浆样本、心电图和包括生命体征在内的体检。此外，患者将被要求1)在所有就诊时填写症状问卷2)保持每日日记以监测血糖控制和胰岛素剂量，3)报告自上次研究就诊以来的医生办公室就诊、急诊室就诊或医院就诊。患者将被要求填写NDI生命质量问卷，并将对GCRC进行13C-辛酸呼气测试(13C-OBT)程序。GCRC的饮食工作人员将准备标准化的饭菜。

ABT-229 is a new drug that belongs to the class of macrolides with motilin agonist activity and without significant antibotic activity. Treatment of diabetic gastroparesis with motility agents have met with some success. ABT-229 has the potential to alter the pathophysiology and improve the symptoms in patients with diabetic gastroparesis without altering the normal gut flora. The objectives of this study are to assess the efficacy of four different doses of ABT-229 compared to placebo for the treatment of postprandial digestive symptoms and to assess the safety of ABT-229 in patients with insulin-requiring diabetes. Patients will be required to refrain from the use of other prokinetic and anti-secretory agents during the study. At each visit, patients will have laboratory tests, pregnancy tests (for females of child bearing potential), pharmacokinetic plasma samples, electrocardiograms, and physical examinations including vital signs. In addition patients will be asked to 1) complete a symptom questionnaire at all visits 2) keep a daily diary to monitor glycemia control and insulin dosing and 3) report physician office visits, ER visits, or hospital visits, since the previous study visit. Patients will be asked to compelte the NDI Qualify of Life questionnaire and the 13C-Octanoic acid breath test (13C-OBT) procedures will be performed on the GCRC. The GCRC dietary staff will prepare the standarized meal.