Effects of Colesevelam on Insulin Sensitivity in Type 2 Diabetes Mellitus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Difference in Endogenous (Hepatic) Glucose Output During a High-dose Insulin Infusion From Baseline to After 12 Weeks of Treatment.
研究概览
简要总结
This study is designed to assess the potential mechanism of action by which WelChol® (colesevelam) may improve blood glucose control in patients with type 2 diabetes
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 (Participant, Care Provider)
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
- •Patients between the ages of 18 - 75, inclusive
- •Diagnosed with type 2 diabetes
- •Hemoglobin A1c value greater than or equal to 8.0%
- •Antidiabetic treatments may include sulfonylurea agents (non-sulfonylurea agents must be withdrawn)
- •Overweight, obese (body mass index 25-45 kg/m2)
排除标准
- •Change of dose of lipid or blood pressure lowering therapy within past three months
- •Previous treatment with colesevelam for hyperlipidemia
- •Serum triglyceride greater than 500 mg/dL
- •Serum low density lipoprotein-cholesterol less than 60 mg/dL
研究组 & 干预措施
1
colesevelam 3.8g administered daily for 12 weeks
干预措施: Colesevelam (Drug)
2
Colesevelam matching placebo for 12 weeks
干预措施: Colesevelam matching placebo (Drug)
3
open-label Insulin Glargine for 12 weeks
干预措施: Insulin glargine (Lantus) (Drug)
结局指标
主要结局
Difference in Endogenous (Hepatic) Glucose Output During a High-dose Insulin Infusion From Baseline to After 12 Weeks of Treatment.
时间窗: Baseline to 12 weeks
The parameter measured is the endogenous (hepatic) glucose output during a high-dose insulin infusion. A decrease after treatment with colesevelam is indicative of greater sensitivity of the liver to insulin.
Difference in Endogenous (Hepatic) Glucose Output During a Low-dose Insulin Infusion From Baseline to Week 12.
时间窗: Baseline to 12 weeks
The parameter measured is the endogenous (hepatic) glucose output during a low-dose insulin infusion. A decrease is indicative of greater senstitivity of the liver to insulin.
Acute Effect of a Single Dose of Colesevelam on Oral Glucose Absorption From Baseline to First Dose
时间窗: Baseline (Day -4) to first dose (Day 1)
Change in area under the curve for glucose (AUCg) after a glucose tolerance test. A decrease in AUCg is indicative of a drug effect.
次要结局
- The Acute Effect of Colesevelam (Multiple Doses) on Oral Glucose Absorption From Baseline to 12 Weeks(Baseline to 12 weeks)
- Change in Hemoglobin A1C Due to Effect of Colesevelam From Baseline to 12 Weeks(Baseline to 12 weeks)