52 WEEK, ORLISTAT TREATMENT IN OBESE PATIENTS WITH TYPE 2 DIABETES MELLITUS

奥利司他治疗肥胖 2 型糖尿病患者 52 周

• 批准号: 6263518
• 负责人: JANET MCGILL
• 金额: $ 2.44万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6263518
• 关键词: clinical trials; combination therapy; diabetes mellitus therapy; diet therapy; drug screening /evaluation; human subject; human therapy evaluation; metformin; noninsulin dependent diabetes mellitus; nutrition related tag; obesity; weight control agent

The objectives of this Phase III clinical research study are: 1) To determine the effect of orlistat plus diet compared to placebo plus diet on weight loss over 52 weeks in obese Type 2 diabetic patients treated with metformin monotherapy. 2) To determine the effect of orlistat pluse diet compared to placebo plus diet on glycemic control form baseline to week 52 as determined by HbA1c in obese Type 2 diabetic patients patients who are maintained on a stable dose of metformin.

本III期临床研究的目的是：1）在接受二甲双胍单药治疗的肥胖2型糖尿病患者中，确定奥利司他加饮食与安慰剂加饮食相比在52周内对体重减轻的影响。 2)在接受稳定剂量二甲双胍维持治疗的肥胖2型糖尿病患者中，确定奥利司他加饮食与安慰剂加饮食相比对基线至第52周血糖控制（根据HbA1c测定）的影响。