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

点击翻译按钮获取中文摘要

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.