NCT00147719已完成3 期
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of WelChol® in Type 2 Diabetics With Inadequate Glycemic Control on Metformin Monotherapy or Metformin Therapy in Combination With Other Oral Anti-Diabetic Agents
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 48
- 主要终点
- To assess the additional lowering of HbA1C achieved by addition of colesevelam hydrochloride to current antidiabetic therapy
研究概览
简要总结
The purpose of the study is to see how safe and effective and tolerable the use of colesevelam hydrochloride is for type 2 diabetes when added to metformin alone or in combination with other anti-diabetic drugs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years, inclusive
- •Diagnosed with type 2 diabetes
- •Hemoglobin (HbA1c) between 7.5% to 9.5%
- •Prescribed an ADA accepted diet
- •Receiving stable dose of metformin alone or in combination with other oral anti-diabetic medications for 90 days before Visit 1
排除标准
- •History of type 1 diabetes or ketoacidosis
- •History of chronic (more than 2 months) insulin therapy or the initiation of insulin for chronic treatment
- •History of pancreatitis
- •Uncontrolled hypertension
- •Recent severe cardiovascular disease
- •Allergy or toxic response to colesevelam or any of its components
- •Body mass index (BMI) >45 kg/m2
结局指标
主要结局
To assess the additional lowering of HbA1C achieved by addition of colesevelam hydrochloride to current antidiabetic therapy
次要结局
- To assess the effect on high sensitivity C-reactive protein;
- To assess the improvement in insulin sensitivity;
- To assess the fasting plasma glucose and fructosamine lowering effect;
- To assess the glycemic control response rate;
- To assess the improvement in lipids, and lipoproteins;
- To assess the safety and tolerability of colesevelam hydrochloride when added on to current therapy
研究者
研究点 (48)
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