TITRATION EVALUATION OF GLIPIZIDE GITS FOR NIDDM

目的：本研究的目的是评估 每隔4个月对格列吡嗪GITS滴定血红蛋白A1 c 程度.格列吡嗪GITS（一种长效和 用于治疗II型糖尿病的每日给药的口服降血糖剂， 已经证明， 血红蛋白A1 c和GITS剂量范围为5-60 mg。 反之，a 观察到与空腹血糖的剂量反应关系， 剂量范围为5- 20 mg。 然而，分配的治疗持续时间 剂量限于8周。 来自文献的新数据表明， 血红蛋白A1 c的下降明显滞后于 空腹血糖，并适当间隔时间观察 血红蛋白A1 c水平稳定4个月。 方法：这是一项IV期、开放标签、多中心研究， 评价75例患者（所有临床试验机构共计#例），以获得50 完成患者评估。 本研究中的患者开始于 格列吡嗪GITS 5 mg/d，持续4个月。 4个月结束时 间隔，如果未达到正常剂量，则增加研究药物剂量 下一个剂量为10 mg，持续4个月，随后为20 mg， 如有必要，剩余4个月。 患者在空腹状态下进行评估。 在每4个月的间隔结束时。 进行的测试包括 血红蛋白A1 c、脂质、果糖胺、c肽、胰岛素和血浆 葡萄糖 在标准化的Sustacal早餐后，c肽， 胰岛素和血浆葡萄糖水平以30分钟的间隔抽取3 小时

PURPOSE:The purpose of the current study is to assess the effect of titration of glipizide GITS at 4 month intervals on hemoglobin A1c levels. Previous fixed dose studies of glipizide GITS, a long-acting and daily dosed oral hypoglycemic agent for the treatment of type II diabetes, have demonstrated that no dose-response relationship exists between hemoglobin A1c and doses of GITS ranging from 5-60 mg. Conversely, a dose-response relationship was observed with fasting plasma glucose and doses ranging from 5-20mg. However, the duration of treatment at assigned doses was limited to 8 weeks. New data from the literature has indicated that decreases in hemoglobin A1c lag significantly behind decreases in fasting plasma glucose, and the appropriate time interval to observe stable hemoglobin A1c levels is 4 months. METHODS: This is a phase IV, open-label, multicenter study which will evaluate 75 patients (total # for all sites) in order to obtain 50 completed patients for evaluation. Patients in this study are started on glipizide GITS 5 mg daily for 4 months. At the end of the 4 month interval, if euglycemia is not achieved, the study medication is increased to the next dosage of 10 mg for 4 months, followed by 20 mg for the remaining 4 months if necessary. Patients are evaluated in a fasting state at the end of each 4 month interval. The tests performed include hemoglobin A1c, lipids, fructosamine, c-peptide, insulin and plasma glucose. Following a standardized breakfast of Sustacal, c-peptide, insulin, and plasma glucose levels are drawn at 30 minute intervals for 3 hours.