ABT 229 (2 YR TX ) FOR PP DIGESTIVE SYMPTOMS IN INSULIN REQUIRING DIA

这是ABT-229(雅培制药)的第二阶段、开放标签、多中心研究。对有或没有胃瘫的糖尿病患者，有慢性餐后消化症状的患者，给予固定剂量的5 mg，bid。在M96-565(SPID 0736)研究中随机接受治疗的患者有资格参加。患者可以接受最长两年的研究药物。本研究的目的是评估5 mg ABT-229长期治疗(2年)对需要胰岛素的糖尿病患者餐后消化症状的安全性和有效性。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。这项研究将包括在治疗开始后一个月和每三个月进行一次随访，最长可达两年。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。每隔6个月，患者将被要求完成NDI生命质量调查问卷，并在第1个月、第6、12、18、24个月对GCRC进行13C-辛酸呼气试验(13C-OBT)。GCRC的饮食工作人员将准备标准化的饭菜。

This is a Phase II, open-label, multi-center study of ABT-229 (Abbott Pharm.) administered at a fixed dose of 5 mg BID in diabetic patients with or without gastroparesis who have evidence of chronic postprandial digestive symptoms. Patients who were randomized to treatment in the M96-565 (SPID 0736) study are eligible to participate. Patients may receive study drug for up to two years. The objectives of this study are to assess the safety and efficacy of long term treatment (2 years) with 5 mg ABT-229 on postprandial digestive symptoms 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. The study will consist of follow up visits at one month and every 3 months after the start of treatment for up to 2 years. 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. Every 6 months, patients will be asked to complete the NDI Qualify of Life questionnaire and the 13C-Octanoic acid breath test (13C-OBT) procedures will be performed on the GCRC at the Month 1 Visit and at the Month 6,12,18, and 24 Visits. The GCRC dietary staff will prepare the standarized meal.