NCT00116831已完成3 期
A Phase III, 18 Month, Multicenter, Randomized, Double-Blind, Active-Controlled Clinical Trial to Compare Rosiglitazone Versus Glipizide on the Progression of Atherosclerosis in Subjects With Type 2 Diabetes Mellitus and Cardiovascular Disease (APPROACH)
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
- 672
- 试验地点
- 1
- 主要终点
- Change From Baseline in Percent Atheroma Volume (PAV) to Month 18
研究概览
简要总结
The purpose of this study is to test the safety and effectiveness of rosiglitazone against a sulfonylurea in reducing or slowing the development of atherosclerosis in the blood vessels of the heart.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Type 1 diabetes and/or history of diabetic ketoacidosis.
- •Exposure to a TZD or other PPAR-g agonist within the 6 months prior to screening visit.
- •Subjects treated with triple OAD therapy or high dose dual combination OAD therapy [1].
- •Subjects who have required chronic insulin use in the last 6 months (except during pregnancy or acute episodes such as hospitalization, trauma or infection).
- •ST segment elevation myocardial infarction in the last 30 days.
- •Subjects who have a history or are scheduled to receive coronary artery bypass graft surgery (CABG), valve repair or replacement, aneurysmectomy or planned major non-cardiac surgery during the study period.
- •Subjects who have severe cardiac valvular disease
- •Stroke or resuscitated in the past 6 months
- •History of congestive heart failure (NYHA class I - IV)
- •History of significant hypersensitivity or reaction (e.g., difficulty swallowing, difficulty breathing, tachycardia or skin reaction) to any TZD, SU, biguanide or insulin
- •Prior history of severe edema or edema requiring medical treatment.
- •Chronic disease requiring chronic or intermittent treatment with oral, intravenous, or injected corticosteroids (use of topical, inhaled, or nasal corticosteroids is permissible).
- •Recent history or suspicion of current drug abuse or alcohol abuse within the last 6 months.
- •Untreated hypo- or hyperthyroidism
- •A diagnosis of cancer (other than superficial squamous, basal cell skin cancer, or adequately treated cervical carcinoma in situ) in the past 3 years or current treatment for the active cancer.
- •Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgement of the Investigator, would preclude safe completion of the study.
- •Blood pressure: SBP >170 or DBP > 100 mmHg
- •Significant anemia (Hemoglobin < 11 g/dL for males and < 10 g/dL for females).
- •Significant renal disease manifested by serum creatinine (> 1.5mg/dL for males or > 1.4mg/dL for females), or where the use of metformin is contra-indicated.
- •Hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (ALT or AST > 2.5 times upper limit of normal (ULN) or bilirubin >2x ULN).
- •History of myopathy or history of elevated creatine kinase (CK) > 3 times upper normal limit.
- •Use of an investigational drug within 30 days or 5 half-lives (whichever is the longer).
- •Women who are lactating, pregnant or planning to become pregnant during the course of the study.
- •Unwillingness or inability to comply with the procedures described in this protocol.
研究组 & 干预措施
Glipizide
Active Comparator
oral anti-diabetic medication
干预措施: Glipizide (Drug)
rosiglitazone maleate
Experimental
oral anti-diabetic medication
干预措施: rosiglitazone maleate (Drug)
结局指标
主要结局
Change From Baseline in Percent Atheroma Volume (PAV) to Month 18
时间窗: Baseline to Month 18
The primary efficacy endpoint was change in PAV (defined as total atheroma volume divided by total vessel volume x 100) within a 40 mm segment in non-intervened coronary arteries from Baseline to Month 18, based upon Intravascular Ultrasound (IVUS) assessment.
Model Adjusted Change From Baseline in Percent Atheroma Volume (PAV) to Month 18
时间窗: Baseline to Month 18
Model Adjusted Change (MAC) = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior Oral Anti-Hyperglycemic Diabetic Medications(s) (OAD).
次要结局
- Model Adjusted Change From Baseline in Vessel Volume to Month 18(Baseline to Month 18)
- Change From Baseline in Atheroma, Vessel, and Lumen Volume to Month 18(Baseline to Month 18)
- Model Adjusted Change From Baseline in Lumen Volume to Month 18(Baseline to Month 18)
- Change From Baseline in Atheroma, Vessel, and Lumen Area to Month 18(Baseline to Month 18)
- Percent Change in Brain Natriuretic Peptide (BNP) From Baseline to Month 18(Baseline to Month 18)
- Model Adjusted Change in Atheroma Area Within the 10 mm of the Non-intervened Vessel Segment With the Greatest Atheroma Volume at Baseline(Baseline to Month 18)
- Model Adjusted Change in Fasting Plasma Glucose (FPG) From Baseline to Month 18(Baseline to Month 18)
- Percent Change From Baseline to Month 18 in HDL-3(Baseline to Month 18)
- Percent Change From Baseline to Month 18 in Low Density Lipoprotein Cholesterol (LDL-c)(Baseline to Month 18)
- Percent Change From Baseline to Month 18 in Triglycerides (TG)(Baseline to Month 18)
- Change From Baseline to Month 18 in LDL-c Peak Particle Density Measured by LDL Relative Flotation(Baseline to Month 18)
- Model Adjusted Change From Baseline in Atheroma Volume to Month 18(Baseline to Month 18)
- Repeated Measures Analysis of Percent Change in hsCRP From Baseline to Month 18(Baseline to Month 18)
- Repeated Measures Analysis of Percent Change in MMP 9 From Baseline to Month 18(Baseline to Month 18)
- Percent Change From Baseline to Month 18 in Total Cholesterol (TC)(Baseline to Month 18)
- Percent Change From Baseline to Month 18 in High Density Lipoprotein Cholesterol (HDL-c)(Baseline to Month 18)
- Percent Change From Baseline to Month 18 in Free Fatty Acids (FFA)(Baseline to Month 18)
- Model Adjusted Change From Baseline in Atheroma Area to Month 18(Baseline to Month 18)
- Model Adjusted Change From Baseline in Vessel Area to Month 18(Baseline to Month 18)
- Change From Baseline in Normalized Atheroma Volume(Baseline to Month 18)
- Model Adjusted Change From Baseline in Normalized Atheroma Volume(Baseline to Month 18)
- Change in Atheroma Area Within the 10 mm of the Non-intervened Vessel Segment With the Greatest Atheroma Volume at Baseline(Baseline to Month 18)
- Model Adjusted Percent Change in Brain Natriuretic Peptide (BNP) From Baseline to Month 18(Baseline to Month 18)
- Percent Change From Baseline to Month 18 in HDL-2(Baseline to Month 18)
- Change From Baseline to Month 18 in Total Cholesterol/HDL-c Ratio(Baseline to Month 18)
- Model Adjusted Change From Baseline in Lumen Area to Month 18(Baseline to Month 18)
- Change in Atheroma Volume Within the 10 mm of the Non-intervened Vessel Segment With the Greatest Atheroma Volume at Baseline(Baseline to Month 18)
- Model Adjusted Change in Atheroma Volume Within the 10 mm of the Non-intervened Vessel Segment With the Greatest Atheroma Volume at Baseline(Baseline to Month 18)
- Model Adjusted Change in Glycated Hemoglobin (HbA1c) From Baseline to Month 18(Baseline to Month 18)
- Percent Change From Baseline to Month 18 in Apoprotein B (apoB)(Baseline to Month 18)
- Change From Baseline to Month 18 in LDL-c/HDL-c Ratio(Baseline to Month 18)
- Number of Participants With the Indicated Treatment Emergent Major Cardiovascular Events (MACE) for All-cause Death, Non-fatal MI, Non-fatal Stroke, Coronary Revascularization, or Hospitalization for Recurrent Myocardial Ischemia (MACE Composite 1)(Baseline to Month 21)
- Number of Other Cardiovascular Events(Baseline to Month 21)
- Number of Participants With the Indicated Treatment Emergent Major Cardiovascular Events (MACE) for Cardiovascular Death, Nonfatal MI, or Nonfatal Stroke (MACE Composite 2)(Baseline to Month 21)
研究者
研究点 (1)
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