A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of the Combination of SYR-322 (SYR110322) and Pioglitazone HCl (ACTOS®), in Subjects With Type 2 Diabetes
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,554
- 主要终点
- Change From Baseline to Week 26 in Glycosylated Hemoglobin (HbA1c) (Grouped Analysis)
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of alogliptin, once daily (QD), taken in combination with pioglitazone in adults with type 2 diabetes mellitus.
详细描述
Over the past 30 years, the prevalence of diabetes has increased dramatically throughout the world due to population growth, aging, urbanization, increasing obesity, and physical inactivity. The total number of people with type 2 diabetes mellitus is projected to rise from 171 million in 2000 to 366 million in 2030. The incidence of type 2 diabetes mellitus in the United States alone is expected to increase from approximately 17 to 30.3 million by the year 2030. Type 2 diabetes mellitus is associated with a number of long-term microvascular and macrovascular complications associated with a reduced quality of life and increased morbidity and mortality. It is anticipated that the increasing incidence of type 2 diabetes mellitus will place an ever-increasing burden on families, increase national expenditures for health care services, and decrease worker productivity.
Current pharmacologic interventions for type 2 diabetes mellitus include a diverse range of antidiabetic medications with different mechanisms of action including insulin and insulin analogues, sulfonylureas, metformin, meglitinides, thiazolidinediones, inhibitors of alpha-glucosidase, analogs of glucagon-like peptide-1 and synthetic analogues of human amylin. Despite the variety of medications, many have clinically important or potentially life-threatening side effects, restricted use in many subpopulations, concerns with long-term tolerability, and challenges related to compliance due to side effects and route of administration. All of these reasons contribute to the difficulties patients have achieving the target glycosylated hemoglobin level less than 7%.
SYR-322 (alogliptin) is a selective, orally available inhibitor of the dipeptidyl peptidase-4 enzyme. Dipeptidyl peptidase-4 enzyme is thought to be primarily responsible for the in vivo degradation of 2 peptide hormones released in response to nutrient ingestion, namely glucagon-like peptide-1 and glucose-dependent insulinotropic peptide. Both peptides exert important effects on islet beta cells to stimulate glucose-dependent insulin secretion as well as regulating beta cell proliferation and cytoprotection. Glucagon-like peptide-1, but not glucose-dependent insulinotropic peptide, inhibits gastric emptying, glucagon secretion, and food intake. Glucose-dependent insulinotropic peptide has been shown to enhance insulin secretion by direct interaction with a glucose-dependent insulinotropic peptide -specific receptor on islet beta cells. The glucose-lowering actions of glucagon-like peptide-1, but not glucose-dependent insulinotropic peptide, are preserved in patients with type 2 diabetes mellitus.
Pioglitazone (ACTOS®) is a thiazolidinedione developed by Takeda Chemical Industries, Ltd. (Osaka, Japan) that is approved for the treatment of type 2 diabetes mellitus. Pioglitazone is a selective peroxisome proliferator-activated receptor-gamma agonist that decreases insulin resistance in the periphery and liver resulting in increased insulin-dependent glucose disposal and decreased hepatic glucose output.
Given the complementary mechanisms of action of alogliptin (stimulation of insulin secretion) and pioglitazone (enhancement of insulin sensitivity), the goal of this study is to evaluate the efficacy of the combination of alogliptin with pioglitazone in patients who are inadequately controlled on metformin. Study participation is anticipated to be approximately 7 months.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women with a historical diagnosis of type 2 diabetes mellitus who were treated with metformin greater than or equal to 1500 mg alone but were experiencing inadequate glycemic control.
- •A stable dose of metformin of greater than or equal to 1500 mg or maximum tolerated dose.
- •No treatment with antidiabetic agents other than metformin within the 2 months prior to Screening.
- •A body mass index greater than or equal to 23 kg/m^2 and less than or equal to 45 kg/m^
- •Fasting C-peptide greater than or equal to 0.8 ng/mL.
- •Regular use of other, non-excluded medications was allowed if a stable dose had been established for at least 4 weeks prior to Screening.
- •Systolic blood pressure less than or equal to 160 mmHg and diastolic pressure less than or equal to 100 mmHg.
- •Hemoglobin greater than or equal to 12 g/dL for men and greater than or equal to 10 g/dL for women.
- •Alanine aminotransferase less than or equal to 2.5 times the upper limit of normal.
- •Serum creatinine less than 1.5 mg/dL for men and less than 1.4 mg/dL for women.
- •Thyroid-stimulating hormone level less than or equal to the upper limit of the normal range and the subject was clinically euthyroid.
- •Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
- •Able and willing to monitor their own blood glucose concentrations with a home glucose monitor.
- •No major illness or debility that in the investigator's opinion prohibited the patient from completing the study.
排除标准
- •Urine albumin/creatinine ratio greater than 113 mg/mmol at Screening.
- •A history of cancer, other than squamous cell or basal cell carcinoma of the skin, that had not been in full remission for at least 5 years prior to Screening.
- •A history of laser treatment for proliferative diabetic retinopathy within 6 months prior to Screening.
- •A history of treated diabetic gastroparesis.
- •New York Heart Association Class III or IV heart failure regardless of therapy.
- •History of coronary angioplasty, coronary stent placement, coronary bypass surgery, or myocardial infarction within the 6 months prior to Screening.
- •History of any hemoglobinopathy.
- •History of infection with hepatitis B, hepatitis C or human immunodeficiency virus.
- •History of a psychiatric disorder that could have affected the patient's ability to participate in the study.
- •History of angioedema in association with use of angiotensin-converting enzyme inhibitors or angiotensin-II receptor inhibitors.
- •A history of alcohol or substance abuse within 2 years prior to Screening.
- •Receipt of any investigational drug within 30 days prior to Screening or a history of receipt of an investigational antidiabetic drug within 3 months prior to Screening.
- •Previous participation in an investigational study of alogliptin.
- •Hypersensitive to pioglitazone, alogliptin, or other excipients.
研究组 & 干预措施
Placebo
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
干预措施: Alogliptin placebo (Drug)
Placebo
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
干预措施: Pioglitazone placebo (Drug)
Alogliptin 12.5 + Placebo
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
干预措施: Alogliptin (Drug)
Alogliptin 12.5 + Placebo
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
干预措施: Pioglitazone placebo (Drug)
Alogliptin 25 + Placebo
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
干预措施: Alogliptin (Drug)
Alogliptin 25 + Placebo
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
干预措施: Pioglitazone placebo (Drug)
Placebo + Pioglitazone 15
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
干预措施: Pioglitazone (Drug)
Alogliptin 12.5 + Pioglitazone 15
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
干预措施: Alogliptin (Drug)
Alogliptin 12.5 + Pioglitazone 15
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
干预措施: Pioglitazone (Drug)
Alogliptin 25 + Pioglitazone 15
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
干预措施: Alogliptin (Drug)
Alogliptin 25 + Pioglitazone 15
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
干预措施: Pioglitazone (Drug)
Placebo + Pioglitazone 30
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
干预措施: Alogliptin placebo (Drug)
Placebo + Pioglitazone 30
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
干预措施: Pioglitazone (Drug)
Alogliptin 12.5 + Pioglitazone 30
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
干预措施: Alogliptin (Drug)
Alogliptin 12.5 + Pioglitazone 30
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
干预措施: Pioglitazone (Drug)
Alogliptin 25 + Pioglitazone 30
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
干预措施: Alogliptin (Drug)
Alogliptin 25 + Pioglitazone 30
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
干预措施: Pioglitazone (Drug)
Placebo + Pioglitazone 45
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
干预措施: Alogliptin placebo (Drug)
Placebo + Pioglitazone 45
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
干预措施: Pioglitazone (Drug)
Alogliptin 12.5 + Pioglitazone 45
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
干预措施: Alogliptin (Drug)
Alogliptin 12.5 + Pioglitazone 45
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
干预措施: Pioglitazone (Drug)
Alogliptin 25 + Pioglitazone 45
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
干预措施: Alogliptin (Drug)
Alogliptin 25 + Pioglitazone 45
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
干预措施: Pioglitazone (Drug)
结局指标
主要结局
Change From Baseline to Week 26 in Glycosylated Hemoglobin (HbA1c) (Grouped Analysis)
时间窗: Baseline and Week 26
The change from Baseline to Week 26 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound). The primary analysis compared the groupings (combinations of individual treatment groups) of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone (Pioglitazone Alone).
Change From Baseline to Week 26 in HbA1c
时间窗: Baseline and Week 26
The change from Baseline to Week 26 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound).
次要结局
- Change From Baseline in HbA1c Over Time (Grouped Analysis)(Baseline and Weeks 4, 8, 12, 16 and 20.)
- Change From Baseline to Week 4 in HbA1c(Baseline and Week 4)
- Change From Baseline to Week 8 in HbA1c(Baseline and Week 8)
- Change From Baseline to Week 12 in HbA1c(Baseline and Week 12)
- Change From Baseline to Week 16 in HbA1c(Baseline and Week 16)
- Change From Baseline to Week 20 in HbA1c(Baseline and Week 20)
- Change From Baseline in Fasting Plasma Glucose Over Time (Grouped Analysis)(Baseline and Weeks 1, 2, 4, 8, 12, 16, 20 and 26.)
- Change From Baseline to Week 1 in Fasting Plasma Glucose(Baseline and Week 1)
- Change From Baseline to Week 2 in Fasting Plasma Glucose(Baseline and Week 2)
- Change From Baseline to Week 4 in Fasting Plasma Glucose(Baseline and Week 4)
- Change From Baseline to Week 8 in Fasting Plasma Glucose(Baseline and Week 8)
- Change From Baseline to Week 12 in Fasting Plasma Glucose(Baseline and Week 12)
- Change From Baseline to Week 16 in Fasting Plasma Glucose(Baseline and Week 16)
- Change From Baseline to Week 20 in Fasting Plasma Glucose(Baseline and Week 20)
- Change From Baseline to Week 26 in Fasting Plasma Glucose(Baseline and Week 26)
- Percentage of Participants With Marked Hyperglycemia (Grouped Analysis)(From Week 1 to Week 26)
- Percentage of Participants With Marked Hyperglycemia(From Week 1 to Week 26)
- Percentage of Participants Meeting Rescue Criteria (Grouped Analysis)(From Week 1 to Week 26.)
- Percentage of Participants Meeting Rescue Criteria(From Week 1 to Week 26)
- Percentage of Participants With Glycosylated Hemoglobin ≤ 6.5% (Grouped Analysis)(Week 26)
- Percentage of Participants With Glycosylated Hemoglobin ≤ 6.5%(Week 26)
- Percentage of Participants With Glycosylated Hemoglobin ≤ 7.0% (Grouped Analysis)(Week 26)
- Percentage of Participants With Glycosylated Hemoglobin ≤ 7%(Week 26)
- Percentage of Participants With Glycosylated Hemoglobin ≤ 7.5% (Grouped Analysis)(Week 26)
- Percentage of Participants With Glycosylated Hemoglobin ≤ 7.5%(Week 26)
- Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 0.5% (Grouped Analysis)(Baseline and Week 26)
- Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 0.5%(Baseline and Week 26)
- Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 1% (Grouped Analysis)(Baseline and Week 26)
- Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 1%(Baseline and Week 26)
- Change From Baseline to Week 8 in Total Cholesterol Levels(Baseline and Week 8)
- Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 1.5% (Grouped Analysis)(Baseline and Week 26)
- Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 1.5%(Baseline and Week 26)
- Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 2.0% (Grouped Analysis)(Baseline and Week 26.)
- Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 2%(Baseline and Week 26)
- Change From Baseline in Fasting Proinsulin Over Time (Grouped Analysis)(Baseline and Weeks 4, 8, 12, 16, 20 and 26.)
- Change From Baseline to Week 4 in Fasting Proinsulin(Baseline and Week 4)
- Change From Baseline to Week 8 in Fasting Proinsulin(Baseline and Week 8)
- Change From Baseline to Week 12 in Fasting Proinsulin(Baseline and Week 12)
- Change From Baseline to Week 16 in Fasting Proinsulin(Baseline and Week 16)
- Change From Baseline to Week 20 in Fasting Proinsulin(Baseline and Week 20)
- Change From Baseline to Week 26 in Fasting Proinsulin(Baseline and Week 26)
- Change From Baseline in Insulin Over Time (Grouped Analysis)(Baseline and Weeks 4, 8, 12, 16, 20 and 26.)
- Change From Baseline to Week 4 in Insulin Levels(Baseline and Week 4)
- Change From Baseline to Week 8 in Insulin Levels(Baseline and Week 8)
- Change From Baseline to Week 12 in Insulin Levels(Baseline and Week 12)
- Change From Baseline to Week 16 in Insulin Levels(Baseline and Week 16)
- Change From Baseline to Week 20 in Insulin Levels(Baseline and Week 20)
- Change From Baseline to Week 26 in Insulin Levels(Baseline and Week 26)
- Change From Baseline in Proinsulin/Insulin Ratio Over Time (Grouped Analysis)(Baseline and Weeks 4, 8, 12, 16, 20 and 26.)
- Change From Baseline to Week 4 in Proinsulin/Insulin Ratio(Baseline and Week 4)
- Change From Baseline to Week 8 in Proinsulin/Insulin Ratio(Baseline and Week 8)
- Change From Baseline to Week 12 in Proinsulin/Insulin Ratio(Baseline and Week 12)
- Change From Baseline to Week 16 in Proinsulin/Insulin Ratio(Baseline and Week 16)
- Change From Baseline to Week 20 in Proinsulin/Insulin Ratio(Baseline and Week 20)
- Change From Baseline to Week 26 in Proinsulin/Insulin Ratio(Baseline and Week 26)
- Change From Baseline in C-peptide Over Time (Grouped Analysis)(Baseline and Weeks 4, 8, 12, 16, 20 and 26.)
- Change From Baseline to Week 4 in C-peptide Levels(Baseline and Week 4)
- Change From Baseline to Week 8 in C-peptide Levels(Baseline and Week 8)
- Change From Baseline to Week 12 in C-peptide Levels(Baseline and Week 12)
- Change From Baseline to Week 16 in C-peptide Levels(Baseline and Week 16)
- Change From Baseline to Week 20 in C-peptide Levels(Baseline and Week 20)
- Change From Baseline to Week 26 in C-peptide Levels(Baseline and Week 26)
- Change From Baseline in Total Cholesterol Over Time (Grouped Analysis)(Baseline and Weeks 4, 8, 12, 16, 20 and 26.)
- Change From Baseline to Week 4 in Total Cholesterol Levels(Baseline and Week 4)
- Change From Baseline to Week 12 in Total Cholesterol Levels(Baseline and Week 12)
- Change From Baseline to Week 16 in Total Cholesterol Levels(Baseline and Week 16)
- Change From Baseline to Week 20 in Total Cholesterol Levels(Baseline and Week 20)
- Change From Baseline to Week 26 in Total Cholesterol Levels(Baseline and Week 26)
- Change From Baseline in Low-Density Lipoprotein Cholesterol Over Time (Grouped Analysis)(Baseline and Weeks 4, 8, 12, 16, 20 and 26.)
- Change From Baseline to Week 4 in Low-Density Lipoprotein Cholesterol(Baseline and Week 4)
- Change From Baseline to Week 8 in Low-Density Lipoprotein Cholesterol(Baseline and Week 8)
- Change From Baseline to Week 12 in Low-Density Lipoprotein Cholesterol(Baseline and Week 12)
- Change From Baseline to Week 16 in Low-Density Lipoprotein Cholesterol(Baseline and Week 16)
- Change From Baseline to Week 20 in Low-Density Lipoprotein Cholesterol(Baseline and Week 20)
- Change From Baseline to Week 26 in Low-Density Lipoprotein Cholesterol(Baseline and Week 26)
- Change From Baseline in High-Density Lipoprotein Cholesterol Over Time (Grouped Analysis)(Baseline and Weeks 4, 8, 12, 16, 20 and 26.)
- Change From Baseline to Week 4 in High-Density Lipoprotein Cholesterol(Baseline and Week 4)
- Change From Baseline to Week 8 in High-Density Lipoprotein Cholesterol(Baseline and Week 8)
- Change From Baseline to Week 12 in High-Density Lipoprotein Cholesterol(Baseline and Week 12)
- Change From Baseline to Week 16 in High-Density Lipoprotein Cholesterol(Baseline and Week 16)
- Change From Baseline to Week 20 in High-Density Lipoprotein Cholesterol(Baseline and Week 20)
- Change From Baseline to Week 26 in High-Density Lipoprotein Cholesterol(Baseline and Week 26)
- Change From Baseline in Triglycerides Over Time (Grouped Analysis)(Baseline and Weeks 4, 8, 12, 16, 20 and 26.)
- Change From Baseline to Week 4 in Triglyceride Levels(Baseline and Week 4)
- Change From Baseline to Week 8 in Triglyceride Levels(Baseline and Week 8)
- Change From Baseline to Week 12 in Triglyceride Levels(Baseline and Week 12)
- Change From Baseline to Week 16 in Triglyceride Levels(Baseline and Week 16)
- Change From Baseline to Week 20 in Triglyceride Levels(Baseline and Week 20)
- Change From Baseline to Week 26 in Triglyceride Levels(Baseline and Week 26)
- Change From Baseline to Week 12 in Body Weight(Baseline and Week 12)
- Change From Baseline in Free Fatty Acids Over Time (Grouped Analysis)(Baseline and Weeks 12 and 26.)
- Change From Baseline to Week 12 in Free Fatty Acids(Baseline and Week 12)
- Change From Baseline to Week 26 in Free Fatty Acids(Baseline and Week 26)
- Change From Baseline in Plasminogen Activator Inhibitor-1 Over Time (Grouped Analysis)(Baseline and Weeks 12 and 26.)
- Change From Baseline to Week 12 in Plasminogen Activator Inhibitor-1(Baseline and Week 12)
- Change From Baseline to Week 26 in Plasminogen Activator Inhibitor-1(Baseline and Week 26)
- Change From Baseline in High-sensitivity C-Reactive Protein Over Time (Grouped Analysis)(Baseline and Weeks 12 and 26.)
- Change From Baseline to Week 12 in High-sensitivity C-Reactive Protein(Baseline and Week 12)
- Change From Baseline to Week 26 in High-sensitivity C-Reactive Protein(Baseline and Week 26)
- Change From Baseline to Week 12 in IDL Particles(Baseline and Week 12)
- Change From Baseline in Adiponectin Over Time (Grouped Analysis)(Baseline and Weeks 12 and 26.)
- Change From Baseline to Week 12 in Adiponectin(Baseline and Week 12)
- Change From Baseline to Week 26 in Adiponectin(Baseline and Week 26)
- Change From Baseline in Body Weight Over Time (Grouped Analysis)(Baseline and Weeks 8, 12, 20 and 26.)
- Change From Baseline to Week 8 in Body Weight(Baseline and Week 8)
- Change From Baseline to Week 20 in Body Weight(Baseline and Week 20)
- Change From Baseline to Week 26 in Body Weight(Baseline and Week 26)
- Change From Baseline in Calculated Homeostatic Model Assessment Insulin Resistance (HOMA IR) (Grouped Analysis)(Baseline and Weeks 12 and 26.)
- Change From Baseline to Week 12 in Calculated HOMA Insulin Resistance(Baseline and Week 12)
- Change From Baseline to Week 26 in Calculated HOMA Insulin Resistance(Baseline and Week 26)
- Change From Baseline in Homeostatic Model Assessment Beta Cell Function (Grouped Analysis)(Baseline and Weeks 12 and 26)
- Change From Baseline to Week 12 in Calculated HOMA Beta-cell Function(Baseline and Week 12)
- Change From Baseline to Week 26 in Calculated HOMA Beta-cell Function(Baseline and Week 26)
- Change From Baseline in Apolipoprotein A1 Over Time (Grouped Analysis)(Baseline and Weeks 12 and 26.)
- Change From Baseline to Week 12 in Apolipoprotein A1(Baseline and Week 12)
- Change From Baseline to Week 26 in Apolipoprotein A1(Baseline and Week 26)
- Change From Baseline in Apolipoprotein A2 Over Time (Grouped Analysis)(Baseline and Weeks 12 and 26)
- Change From Baseline to Week 12 in Apolipoprotein A2(Baseline and Week 12)
- Change From Baseline to Week 26 in Apolipoprotein A2(Baseline and Week 26)
- Change From Baseline in Apolipoprotein B Over Time (Grouped Analysis)(Baseline and Weeks 12 and 26)
- Change From Baseline to Week 12 in Apolipoprotein B(Baseline and Week 12)
- Change From Baseline to Week 26 in Apolipoprotein B(Baseline and Week 26)
- Change From Baseline in Apolipoprotein C-III Over Time (Grouped Analysis)(Baseline and Weeks 12 and 26)
- Change From Baseline to Week 12 in Apolipoprotein C-III(Baseline and Week 12)
- Change From Baseline to Week 26 in Apolipoprotein C-III(Baseline and Week 26)
- Change From Baseline in Nuclear Magnetic Resonance Lipid Fractionation Total Triglycerides Over Time (Grouped Analysis)(Baseline and Weeks 12 and 26.)
- Change From Baseline to Week 12 in NMR Lipid Fractionation Total Triglycerides(Baseline and Week 12)
- Change From Baseline to Week 26 in NMR Lipid Fractionation Total Triglycerides(Baseline and Week 26)
- Change From Baseline in Very Low Density Lipoprotein (VLDL) / Chylomicron Particles Over Time (Grouped Analysis)(Baseline and Weeks 12 and 26)
- Change From Baseline to Week 12 in VLDL / Chylomicron Particles(Baseline and Week 12)
- Change From Baseline to Week 26 in VLDL / Chylomicron Particles(Baseline and Week 26)
- Change From Baseline in VLDL / Chylomicron Triglycerides Over Time (Grouped Analysis)(Baseline and Weeks 12 and 26)
- Change From Baseline to Week 12 in VLDL / Chylomicron Triglycerides(Baseline and Week 12)
- Change From Baseline to Week 26 in VLDL / Chylomicron Triglycerides(Baseline and Week 26)
- Change From Baseline in VLDL Particles Over Time (Grouped Analysis)(Baseline and Weeks 12 and 26)
- Change From Baseline to Week 12 in VLDL Particles(Baseline and Week 12)
- Change From Baseline to Week 26 in VLDL Particles(Baseline and Week 26)
- Change From Baseline in Mean VLDL Particle Size Over Time (Grouped Analysis)(Baseline and Weeks 12 and 26)
- Change From Baseline to Week 12 in Mean VLDL Particle Size(Baseline and Week 12)
- Change From Baseline to Week 26 in Mean VLDL Particle Size(Baseline and Week 26)
- Change From Baseline in Intermediate Density Lipoprotein (IDL) Particles Over Time (Grouped Analysis)(Baseline and Weeks 12 and 26)
- Change From Baseline to Week 26 in IDL Particles(Baseline and Week 26)
- Change From Baseline in Low Density Lipoprotein (LDL) Particles Over Time (Grouped Analysis)(Baseline and Weeks 12 and 26)
- Change From Baseline to Week 12 in LDL Particles(Baseline and Week 12)
- Change From Baseline to Week 26 in LDL Particles(Baseline and Week 26)
- Change From Baseline in Mean LDL Particle Size Over Time (Grouped Analysis)(Baseline and Weeks 12 and 26)
- Change From Baseline to Week 12 in Mean LDL Particle Size(Baseline and Week 12)
- Change From Baseline to Week 26 in Mean LDL Particle Size(Baseline and Week 26)
- Change From Baseline in High Density Lipoprotein (HDL) Particles Over Time (Grouped Analysis)(Baseline and Weeks 12 and 26.)
- Change From Baseline to Week 12 in HDL Particles(Baseline and Week 12)
- Change From Baseline to Week 26 in HDL Particles(Baseline and Week 26)
- Change From Baseline in Mean HDL Particle Size Over Time (Grouped Analysis)(Baseline and Weeks 12 and 26)
- Change From Baseline to Week 12 in Mean HDL Particle Size(Baseline and Week 12)
- Change From Baseline to Week 26 in Mean HDL Particle Size(Baseline and Week 26)