NCT00789750已完成3 期
A Randomized, Double-Blind, Placebo Controlled, Parallel Group Study of the Efficacy and Safety of WELCHOL as Add-on to Pioglitazone Therapy for Type 2 Diabetes Mellitus (T2DM)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 562
- 主要终点
- Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24
研究概览
简要总结
The current study investigates colesevelam as add-on therapy to pioglitazone to improve glycemic control in subjects with type 2 diabetes mellitus not adequately controlled with pioglitazone monotherapy or pioglitazone in combination with either metformin or a sulfonylurea. The study will evaluate if colesevelam add-on to pioglitazone therapy 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
- •Diagnosis of Type 2 diabetes mellitus
- •Inadequate glycemic control on a stable dose (at least 2 months prior to screening) of pioglitazone at 30 or 45 mg/day, with or without one or two other oral antidiabetic medications [metformin or a sulfonylurea, or dipeptidyl peptidase (DPP-IV) inhibitor]
- •Hemoglobin A1c (HbA1c) >= 7.5% and =< 9.5% at screening
- •Fasting plasma glucose =<240 mg/dL at randomization (Week 0/Day 1).
- •Male or female >= 18 years of age.
- •Women of childbearing potential must be using an adequate method of contraception as detailed per-protocol
- •Fasting C-peptide level >0.5 ng/mL at screening
- •Clinically stable in regards to medical conditions other than type 2 diabetes
- •Concomitant medications are at stable doses for at least 30 days prior to enrollment, and are not anticipated to need adjustment during the study period
排除标准
- •History of Type 1 diabetes and/or history of ketoacidosis
- •History of bowel obstruction
- •History of hypertriglyceridemia-induced pancreatitis
- •Fasting serum triglyceride concentration >500 mg/dL
- •History of dysphagia, swallowing disorders, gastroparesis, other gastrointestinal motility disorders, major gastrointestinal surgery
- •History of insulin use >= 2 weeks duration during the previous 3 months or a total of >2 months insulin therapy at any time prior to screening
- •Treatment with bile acid sequestrants, including colesevelam within 3 months prior to screening
- •Female subject who is pregnant or breastfeeding
- •History of unstable angina, myocardial infarction, cerebrovascular accident, transient ischemic attack, or any revascularization within 6 months prior to screening
研究组 & 干预措施
Colesevelam
Experimental
Participants receive six colesevelam tablets (3.8 grams/day) in addition to pioglitazone-based therapy (30 mg or 45 mg)
干预措施: Colesevelam (Drug)
Colesevelam
Experimental
Participants receive six colesevelam tablets (3.8 grams/day) in addition to pioglitazone-based therapy (30 mg or 45 mg)
干预措施: Pioglitazone (Drug)
Placebo
Placebo Comparator
Participants receive six placebo tablets in addition to pioglitazone-based therapy (30 mg or 45 mg)
干预措施: Placebo (Drug)
Placebo
Placebo Comparator
Participants receive six placebo tablets in addition to pioglitazone-based therapy (30 mg or 45 mg)
干预措施: Pioglitazone (Drug)
结局指标
主要结局
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24
时间窗: Baseline, Week 24
次要结局
- Change From Baseline in HbA1c at Week 16(Baseline, Week 16)
- Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)(Baseline, Week 24)
- Change From Baseline in HbA1c at Week 4(Baseline, Week 4)
- Number of Participants Achieving an HbA1c Goal of <7.0%(Week 24)
- Change From Baseline in HbA1c at Week 8(Baseline, Week 8)
- Number of Participants With a Decrease of >= 0.7 Percent in HbA1c(Week 24)
- Number of Participants With a Reduction in FPG of >= 30 mg/dL(Week 24)
- Percent Change From Baseline in Total Cholesterol (TC)(Baseline, Week 24)
- Percent Change From Baseline in Apolipoprotein A-1 (Apo A-I)(Baseline, Week 24)
- Percent Change From Baseline in Apolipoprotein B (Apo B)(Baseline, Week 24)
- Change From Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)(Baseline, Week 24)
- Change From Baseline in Fasting C-peptide(Baseline, Week 24)
- Change From Baseline in Fasting Plasma Glucose (FPG)(Baseline, Week 24)
- Percent Change From Baseline in Non-HDL-C(Baseline, Week 24)
- Change From Baseline in Fasting Insulin Levels(Baseline, Week 24)
- Number of Participants With a Decrease of >= 0.5 Percent in HbA1c(Week 24)
- Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)(Baseline, Week 24)
- Percent Change From Baseline in Triglycerides (TG)(Baseline, Week 24)
研究者
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