NCT00151749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 Diabetes With Inadequate Glycemic Control on Insulin Therapy Alone or Insulin Therapy 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
- 260
- 试验地点
- 47
- 主要终点
- - To assess the additional lowering of HbA1c achieved by
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 WelChol® is for type 2 diabetes when added to insulin 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
- •Ages 18 - 75 years, inclusive
- •Diagnosed with type 2 diabetes
- •Stable insulin therapy for 6 weeks
- •Stable dose of any other antidiabetic medications for 90 days
- •Hemoglobin A1c value between 7.5% to 9.5%
- •C peptide greater than 0.5 ng/mL
- •Prescribed ADA diet
排除标准
- •History of type 1 diabetes or ketoacidosis
- •History of pancreatitis
- •Uncontrolled hypertension
- •Allergy or toxic response to colesevelam or any of its components
- •Serum LDL-C less than 60 mg/dL
- •Serum TG greater than 500 mg/dL
- •Body mass index (BMI) greater than 45 kg/m2-
结局指标
主要结局
- To assess the additional lowering of HbA1c achieved by
addition of WelChol® to current antidiabetic therapy
次要结局
- To assess: the effects on fasting plasma glucose and
- fructosamine; glycemic control response rate; effect on adiponectin; the effect on c-peptide; effect on c-reactive protein; effects on lipids and lipoproteins; the safety and tolerability of WelChol® as add-
- on therapy to patients receiving insulin alone or with
- other oral drugs
研究者
研究点 (47)
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