NCT01611883已完成4 期
Examination of the Effect of Ezetimibe on Glucose Metabolism - Randomized, Double-blind, Placebo-controlled Study in Type 2 Diabetes Mellitus Patients With Hypercholesterolemia - Phase 4, Protocol No. 367 (Also Known as SCH 58235, P06541)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 152
- 主要终点
- Change in Glycated Hemoglobin (HbA1c) From Baseline
研究概览
简要总结
This study will examine the effect of ezetimibe on glucose metabolism in participants with Type 2 diabetes and hypercholesterolemia.The primary hypothesis is that change in glycated hemoglobin (HbA1c) from baseline in the ezetimibe treatment group will be non-inferior to the placebo control group.
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, Investigator)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have hypercholesterolemia (high cholesterol) and have been diagnosed with type 2 diabetes that is being treated with oral anti-diabetic drugs or insulin or both.
- •No change in the medication (drugs, dose and administration) for the treatment of diabetes within previous 12 weeks with exception of small changes in insulin dosing
- •No change in diet and exercise therapy within previous 4 weeks
排除标准
- •Coexisting disease (hemoglobinopathy, hemolytic anemia, etc.) that may affect HbA1c measurement
- •Homozygous or heterozygous familial hypercholesterolemia
- •Previously received ezetimibe
- •Hypercholesterolemia associated with: hypothyroidism, obstructive gall bladder or biliary disease, chronic renal failure or pancreatitis
- •Hyperlipidemia caused by medication
研究组 & 干预措施
Ezetimibe
Experimental
10 mg oral dose once daily for 24 weeks
干预措施: Ezetimibe (Drug)
Placebo
Placebo Comparator
Placebo to match ezetimibe orally once daily for 24 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Glycated Hemoglobin (HbA1c) From Baseline
时间窗: Baseline and Week 24
HbA1c is blood marker used to report average blood glucose levels over a prolonged period of time and is reported as a percentage (%). HbA1C was measured at baseline and after 24 weeks of study drug administration.
次要结局
- Change in Fasting Plasma Glucose (FPG) From Baseline(Baseline and Week 24)
- Percentage of Participants With Adverse Event (AE) "Exacerbation of Diabetes"(up to 24 weeks)
- Change in Glycoalbumin From Baseline(Baseline and Week 24)
- Percent Change in Total Cholesterol (TC) From Baseline(Baseline and Week 24)
- Percentage of Participants With Changes in Diabetes Medications Due to Worsening of Diabetes(Up to 24 weeks)
- Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline(Baseline and Week 24)
- Percent Change in Triglycerides From Baseline(Baseline and Week 24)
- Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline(Baseline and Week 24)
- Percent Change in Non-HDL-cholesterol From Baseline(Baseline and Week 24)
研究者
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