NCT00770653已完成3 期
Effects of a Pioglitazone/Metformin Fixed Combination in Comparison to Metformin in Combination With Glimepiride on Diabetic Dyslipidemia
Takeda0 个研究点目标入组 305 人开始时间: 2007年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 305
- 主要终点
- The Mean Increase From Baseline in High-Density Lipoprotein Cholesterol.
研究概览
简要总结
The purpose of this study is to compare pioglitazone and metformin combination therapy, twice daily (BID), to glimepiride and metformin combination therapy for treating diabetic subjects with dyslipidemia.
详细描述
Insulin resistance is a major endocrinopathy preceding the development of hyperglycemia, diabetic dyslipidemia and cardiovascular disease in type 2 diabetes. The most common pattern of dyslipidemia in patients with type 2 diabetes are elevated triglyceride levels, decreased hih-density lipoprotein cholesterol and a predominance of small dense low-density lipoprotein particles. Each of these dyslipidemia features is associated with an increased risk of cardiovascular events.
Pioglitazone and Metformin are established drugs which can be used for the treatment of type 2 diabetes. This study will investigate the effects of treatment with fixed Pioglitazone/Metformin combination therapy of Metformin and Glimepiride in Metformin-pretreated type 2 diabetic patients with dyslipidemia.
Total participation time in this study is anticipated to be approximately 24 weeks.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes according to the American Diabetes Association Criteria.
- •Treatment with individual maximal tolerated dose of metformin (850 - 2000 mg) as monotherapy within the last 12 weeks.
- •Glycosylated Hemoglobin greater than or equal to 6.5% and less than or equal to 9%.
- •Dyslipidemia defined as high-density lipoprotein cholesterol less than or equal to 1.03 mmol/l (40 mg/dL) and/or triglycerides greater than or equal to 1.7 mmol/l (150 mg/dL).
- •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.
排除标准
- •Type 1 diabetes mellitus.
- •Insulin-dependent type 2 diabetes mellitus.
- •Treatment or history of treatment with any insulin formulation other than emergency for more than 2 weeks.
- •Treatment with other oral antidiabetic drugs in addition to metformin within the last 12 weeks.
- •Anamnestic history of hypersensitivity to the study drugs or to drugs with similar chemical structures.
- •Is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
- •Heparin (and heparin-like drugs)
- •phenprocoumon
- •Protein C
- •Fondaparinux
- •antithrombin III
- •Peroxisome Proliferation Activating Receptor (gamma) agonists
- •Treatment within the last 12 weeks with:
- •gemfibrozil
- •Rifampicin
- •Changes in dosage of any statin treatment to lower low-density lipoprotein within 2 weeks before study entry and during study participation interval.
- •Changes in dosage of any anticoagulant treatment with acetyl salicylic acid and/or clopidogrel within 2 weeks before study entry and during study participation interval.
- •Start of statin and/or anticoagulant treatment during study participation interval.
- •History of severe or multiple allergies and/ or acute severe infections.
- •Have had more than one unexplained episode of severe hypoglycemia (defined as requiring assistance of another person due to disabling hypoglycemia) within 6 months prior to screening visit.
- •Progressive fatal disease.
- •Any elective surgery during study participation.
- •History of drug or alcohol abuse within the last 5 years.
- •A history of significant cardiovascular (New York Heart Association stage I - IV), respiratory, gastrointestinal, hepatic (alanine aminotransferase and/or aspartate aminotransferase greater than 2.5 times the upper limit of the normal reference range), renal (serum creatinine greater than 1.2 mg/dL in women and greater than 1.5 mg/dL in men, glomerular filtration rate less than 60 ml/min as estimated by the Cockroft-Gault formula), neurological, psychiatric and/or hematological disease as judged by the investigator, history of macular edema.
- •Blood donation within the last 30 days.
研究组 & 干预措施
Pioglitazone 15 mg and Metformin 850 mg BID
Experimental
干预措施: Pioglitazone and Metformin (Drug)
Glimepiride 2 mg and Metformin 850 mg BID
Active Comparator
干预措施: Glimepiride and Metformin (Drug)
结局指标
主要结局
The Mean Increase From Baseline in High-Density Lipoprotein Cholesterol.
时间窗: Baseline and Week 24.
The increase in High-Density Lipoprotein (HDL) Cholesterol collected at week 24 or final visit and HDL-Cholesterol collected at baseline.
次要结局
- Change From Baseline in High-Density Lipoprotein Cholesterol.(Baseline and Week 24.)
- Change From Baseline in High-Density Lipoprotein/Low-Density Lipoprotein Ratio.(Baseline and Week 24.)
- Change From Baseline in Triglycerides.(Baseline and Week 24.)
- Change From Baseline in Low-Density Lipoprotein Subfractions.(Baseline and Week 24.)
- Change From Baseline in Low-Density Lipoprotein Cholesterol.(Baseline and Week 24.)
- Change From Baseline in Glycosylated Hemoglobin.(Baseline and Week 24.)
- Change From Baseline in Fasting Intact Proinsulin.(Baseline and Week 24.)
- Change From Baseline in Fasting Glucose.(Baseline and Week 24.)
- Change From Baseline in Adiponectin.(Baseline and Week 24.)
- Change From Baseline in High Sensitivity C-reactive Protein (Original).(Baseline and Week 24.)
- Change From Baseline in High Sensitivity C-reactive Protein (≤ 10 mg/L).(Baseline and Week 24.)
- Change From Baseline in Systolic Blood Pressure.(Baseline and Week 24.)
- Change From Baseline in Diastolic Blood Pressure.(Baseline and Week 24.)
- Intake of Study Medication Greater Than 80% and Less Than 120%.(Baseline and Week 24.)
- Change From Baseline in Nitrotyrosine.(Baseline and Week 24.)
- Change From Baseline in Soluble CD40 Ligand.(Baseline and Week 24.)
- Change From Baseline in Matrix Metallo Proteinase-9.(Baseline and Week 24.)
- Change From Baseline in Soluble Intracellular Adhesion Molecule.(Baseline and Week 24.)
- Change From Baseline in Soluble Vascular Cell Adhesion Molecule.(Baseline and Week 24.)
- Change From Baseline in Thromboxane B2.(Baseline and Week 24.)
- Change From Baseline in Platelet Function.(Baseline and Week 24.)
- Change From Baseline in E-Selectin.(Baseline and Week 24.)
- Change From Baseline in Von-Willebrand Factor.(Baseline and Week 24.)
- Change From Baseline in Erythrocyte Deformability (0.30%).(Baseline and Week 24.)
- Change From Baseline in Erythrocyte Deformability (0.60%)(Baseline and Week 24.)
- Change From Baseline in Erythrocyte Deformability (1.20).(Baseline and Week 24.)
- Change From Baseline in Erythrocyte Deformability (3.00).(Baseline and Week 24.)
- Change From Baseline in Erythrocyte Deformability (6.00).(Baseline and Week 24.)
- Change From Baseline in Erythrocyte Deformability (12.00).(Baseline and Week 24.)
- Change From Baseline in Erythrocyte Deformability (30.00).(Baseline and Week 24.)
- Change From Baseline in Erythrocyte Deformability (60.00).(Baseline and Week 24.)
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