子课题3基于分子分型和药物遗传学基础上的2型糖尿病个体-PLOS.DOC

PAGE Evidence-Based Medical Research of Zhongyi Xiaoke Pills ——A Multicenter, randomized, double blind and double dummy, masculine parallel group trial Clinical Trial Protocol Trial title: Evidence-Based Medical Research of Zhongyi Xiaoke Pills Investigational drug generic name: Xiaoke Pills Protocol discussion date: September 2007 Protocol finalization date: October 2007 Unit in charge of the trial: Peking University People’s Hospital (Seal) Principal: Ji Linong (Signed) Data management and statistical analysis: Peking University School of Public Health Statistics manager: Wang Hongyuan Tel: 010 Clinical trial audit unit: Guangzhou Boji Clinical Research Center of New Drugs Project contact: Wang Shuaishuai Tel: 020 Center testing audit unit: Beijing VPS-CRO Group Project contact: Dai Chengxiang Tel: 010284 Sponsor: Guangzhou Zhongyi Pharmaceutical Co., Ltd. (Seal) Address: 11th Floor, West Tower, Times Square, No. 28 Tianhe North Road, Guangzhou Person in charge: Wu Changhai (Signed) Contact: Deng Huimin, Yang Longfei Tel: 020  Chinese Diabetes Society of Chinese Medical Association recommends using the WHO (1999) diagnostic criteria in population of China. 1. Diabetes symptoms + plasma glucose level at any time ≥11.1 mmol/l (200 mg/dl) or 2. Fasting plasma glucose (FPG) level ≥ 7.0 mmol/l (126 mg/dl) 3. OGTT test showing 2-hour PG level ≥ 11.1mmol/l (200 mg/dl) Explanation: In the above table, plasma glucose level refers to venous plasma glucose level, which is determined by glucose oxidase method. It is recommended to determine the venous plasma glucose values. If it uses the finger whole blood and (or) venous whole blood to measure the glucose values, there will be some changes in the division point of diagnosis. See the table below: Diagnostic criteria for blood glucose of diabetes and IGT/IFG B