NCT00789737已完成3 期
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of Welchol as Monotherapy for Type 2 Diabetes Mellitus
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 357
- 主要终点
- Percent Change in Hemoglobin A1c
研究概览
简要总结
The current study investigates Welchol as monotherapy to improve glycemic control in subjects with Type 2 Diabetes Mellitus not adequately controlled with diet and exercise alone. The study will evaluate if Welchol monotherapy for Type 2 Diabetes Mellitus will be safe, well tolerated and efficacious.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects >= 18 years of age;
- •Women of childbearing potential (WOCBP) must be using an adequate method of contraception as detailed in the protocol.
- •Diagnosis of Type 2 Diabetes Mellitus;
- •HbA1C >= 7.5% and =< 9.5 % at screening;
- •Fasting C-peptide >0.5 ng/mL at screening;
- •Drug naïve (no prior treatment with OAD) or having received no pharmacologic therapy for diabetes for the 3 month period prior to screening;
- •Clinically stable in regards to medical conditions other than type 2 diabetes;
- •Concomitant medications must be at stable doses for at least 30 days prior to enrollment, and are not anticipated to need adjustment during the study period; and
- •Fasting glucose =< 240 mg/dL at randomization
排除标准
- •A history of type 1 diabetes and/or a history of ketoacidosis;
- •History of bowel obstruction;
- •History of hypertriglyceridemia-induced pancreatitis;
- •Fasting serum triglyceride concentrations >500 mg/dL;
- •History of dysphagia, swallowing disorders, gastroparesis, other gastrointestinal (GI) motility disorders, or major GI surgery;
- •History of insulin use of >= 2 weeks duration in the previous 3 months or a total of > 2 months of insulin therapy at any time prior to screening;
- •Two or more fasting self-monitored blood glucose (SMBG) levels >240 mg/dL during the placebo lead-in period.
- •Previous treatment with a bile acid sequestrant, including Welchol within the 3 months prior to screening;
- •Body mass index (BMI) >40 kg/m2;
- •Weight loss > 3% in prior 3 months; and
- •LDL <60 mg/dL.
研究组 & 干预措施
Welchol
Experimental
Welchol 625mg tablets
干预措施: Welchol (Drug)
placebo
Placebo Comparator
placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Change in Hemoglobin A1c
时间窗: 24 week
change in HbA1c from baseline to Week 24
次要结局
- % Subjects Achieving an HbA1C Goal of <7.0(24 weeks)
- % Subjects With a Decrease in FPG >=30 mg/dL(from baseline to 24 weeks)
- Change in Fasting Plasma Glucose(from baseline to 24 weeks)
- % Subjects With a Decrease in HbA1c of >= 0.7 Percentage Units(24 weeks)
- Changes in Total Cholesterol [TC](from baseline to 24 weeks)
- Changes in Low Density Lipoprotein Cholesterol [LDL-C](from baseline to 24 weeks)
- Changes in High Density Lipoprotein Cholesterol [HDL-C](from baseline to 24 weeks)
- Changes in Non-HDL-C(from baseline to 24 weeks)
- Changes in Triglycerides [TG](from baseline to 24 weeks)
- Changes in Apolipoprotein A-I (apoA-I)(from baseline to 24 weeks)
- Changes in Apolipoprotein B (apoB)(from baseline to 24 weeks)
- Change in Postprandial Plasma Glucose, 2 Hours After a Meal Tolerance Test(from baseline to 24 weeks)
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