ISRCTN04296019已完成不适用
Multicentre, randomised, double-blind, parallel-group, placebo-controlled clinical trial, comparing nateglinide versus placebo to assess the efficacy and tolerability of nateglinide in patients with type two diabetes mellitus
ovartis Pharma (Novartis Farmacéutica SA) (Spain)0 个研究点目标入组 102 人开始时间: 2006年11月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 102
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Drug-naive 30 to 75 year old subjects with type two Diabetes Mellitus (DM) and less than five years of evolution, who met the following criteria:
- •1. Body Mass Index (BMI): 22 to 35 kg/m^2
- •2. Fasting Plasma Glucose (FPG) less than 13.3 mmol/l
- •3. HbA1c: 6.5 to 8.5%
- •4. Not taking anti-hypertensive drugs
- •To be included, participants were in agreement neither to change their prior diet nor exercise activity during follow-up
排除标准
- •1. Type one diabetes mellitus
- •2. Pregnancy or childbearing females not using oral contraceptives
- •3. Drug-abuse
- •4. Severe psychiatric disorders
- •5. Treatment with oral corticosteroids, insulin or other oral hypoglycemic agents
- •6. Serum creatinine more than 160 mmol/L
- •7. Alanine Transaminase (ALT) and/or Aspartate Transaminase (AST) more than 2.0 x Upper Limit of Normal (ULN)
- •8. Thyroid dysfunction
- •9. Fasting triglycerides more than 7.0 mmol/L
- •10. Total cholesterol more than 9.1 mmol/
研究者
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