Use of Continuous Glucose Monitoring With Ambulatory Glucose Profile Analysis to Demonstrate the Glycemic Effect of Colesevelam HCl (Welchol) in Patients With Type 2 Diabetes
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Total Norm AUC Average by Group (Normalized)
研究概览
简要总结
The purpose of this study is to obtain continuous glucose monitoring (CGM) data from individuals taking Welchol compared to placebo. The CGM data will determine the effect on glucose control of adding Welchol to an anti-diabetic medication regimen.
详细描述
To understand the effect of the addition of colesevelam HCl to oral agent therapy in individuals with type 2 diabetes on glycemic control by utilizing a novel technology, continuous glucose monitoring with ambulatory glucose profile analysis. To date there are no studies of this compound that have employed continuous glucose monitoring (CGM) with ambulatory glucose profile (AGP) analysis to obtain data that will detail the diurnal glucose patterns associated with this therapy. We plan to employ CGM at critical points throughout the study. AGP analysis will enable rapid assessment of the clinical status of the subject. Using statistically stable estimates of hourly values represented by five percentile curves AGP depicts glucose exposure, variability and stability. Previously, we have used AGP analysis to characterize glucose perturbations in individuals ranging from normal glucose tolerance to overt type 2 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Male or female subjects ≥18 and ≤75 years of age
- •Clinical diagnosis of type 2 diabetes
- •Currently treated with metformin, a sulfonylurea, or combination metformin/sulfonylurea; stable dose for ≥3 months
- •HbA1c of 7.0-9.0% inclusive
- •If taking lipid lowering medications, stable dose for >30 days
排除标准
- •Taken oral or injected prednisone or cortisone medications in the previous 30 days. (Topical or inhaled steroids will not be considered excluded medications.)
- •Current use of insulin or TZD's, or incretins
- •LDL <70 mg/dL
- •Serum triglycerides >500 mg/dL
- •History of hypertriglyceridemia-induced pancreatitis
- •History of gastrointestinal disorder such as dysphagia, swallowing disorder, intestinal motility disorder or prior bowel obstruction
- •History or presence of any severe medical or psychological condition or chronic conditions/infections that in the opinion of the Investigator would compromise the subject's safety or successful participation in the study
- •Unable to follow the study protocol
- •Unable to speak, read and write in English
- •Pregnant, planning to become pregnant, breast feeding
研究组 & 干预措施
Welchol then Placebo
3.75 grams of colesevelam HCl (Welchol) at evening meal for 12 weeks, and then crossover to placebo at evening meal for 12 weeks.
干预措施: colesevelam HCl (Drug)
Welchol then Placebo
3.75 grams of colesevelam HCl (Welchol) at evening meal for 12 weeks, and then crossover to placebo at evening meal for 12 weeks.
干预措施: placebo (Drug)
Placebo then Welchol
Placebo taken for 12 weeks at evening meal, and then crossover to 3.75 grams of colesevelam HCl taken at evening meal fro 12 weeks.
干预措施: colesevelam HCl (Drug)
Placebo then Welchol
Placebo taken for 12 weeks at evening meal, and then crossover to 3.75 grams of colesevelam HCl taken at evening meal fro 12 weeks.
干预措施: placebo (Drug)
结局指标
主要结局
Total Norm AUC Average by Group (Normalized)
时间窗: 2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2.
Double Blinded CGM used for 2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2.
Sleep Norm AUC Average by Group (Normalized)
时间窗: 2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2.
Overnight glucose captured by CGM.
Hypoglycemia Percentage of Time <70 mg/dL Average by Group
时间窗: 2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2.
Ambulatory glucose profile (AGP) reports were examined for the changes in the incidence of hypoglycemia (CGM\<70 mg/dL)
Wake Norm AUC Average by Group (Normalized)
时间窗: 2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2.
Wake glucose captured by continuous glucose monitoring (CGM).
次要结局
未报告次要终点