EUCTR2005-003347-31-FI进行中（未招募）1 期
Assessment of insulin sensitivity in type 2 diabetics treated with metformin, fenofibrate and their combination - NA
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Males or females aged from 40 to 75 years at inclusion;
- •- T2DM as defined by ADA criteria (fasting glucose > 7.0 mmol/L, e.g. 126 mg/dL; or OGTT glucose at 120 minutes > 11.1 mmol/L, e.g. 200 mg/dL.
- •- Inclusion criteria for inclusion at visit V1:
- •o For patients under oral antidiabetic treatment at inclusion which will be stopped during the washout period: fasting glucose = 6.0 mmol/L and/or OGTT glucose at 120 minutes = 10 mmol/L, and/or HbA1c = 6% and <9% at inclusion or during the last four months before inclusion,
- •o For patients which are not under oral antidiabetic treatment at inclusion, criteria are the same as randomization criteria: fasting glucose = 7.0 mmol/L, and/or OGTT glucose at 120 minutes = 11.1 mmol/L and/or HbA1c = 7% and <10% at inclusion or during the last four months before inclusion
- •- Plus at least one of the following biochemical abnormalities:
- •o Triglycerides (TG) = 150 mg/dL (= 1.69 mmol/L); and/or
- •o HDL-C = 40 mg/dL (= 1.03 mmol/L) for male patients or HDL-C = 50 mg/dL (= 1.29 mmol/L) for female patients;
- •- BMI (body mass index) > 25 kg/m² and = 40 kg/m²
- •- Having signed a written informed consent at inclusion.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Unable or unwilling to comply with the protocol;
- •- Ongoing or past treatment with cyclosporin A or protease inhibitors (indinavir, ritonavir, saquinavir, …);
- •- Ongoing treatment with statins (atorvastatin, simvastatin, pravastatin, rosuvastatin…) at the date of V1
- •- LDL-C = 190 mg/dL (4.9 mmol/L) if no risk factor, LDL-C = 160 mg/dL (4.1 mmol/L) if a single risk factor exists or LDL-C = 130 mg/dL (3.4 mmol/L) in case of two or more risk factors;
- •- Proliferative retinopathy or maculopathy requiring laser therapy;
- •- Ongoing treatment with thiazolinediones (rosiglitazone, pioglitazone…) at the date of V1
- •- Ongoing treatment with insulin at the date of V1
- •- Reporting a change within the last 4 weeks before randomization and during the study in the medications that could interfere with the lipid profile (i.e., betablockers, diuretics, oral corticosteroids, thyroid hormones, retinoids, hormone replacement therapies)
- •- Patients affected with one of the following diseases or conditions:
- •· Chronic respiratory insufficiency, patient with medical device for sleep apnea;
- •· Chronic pancreatitis, or identified risk or known history of acute pancreatitis;
- •· Hepatic insufficiency, acute alcohol intoxication, alcoholism
- •· Renal insufficiency with calculated creatinine clearance = 60 mL/min
- •· Acute or chronic disease which may cause tissue hypoxia such as cardiac or respiratory failure, recent myocardial infarction (within 3 months prior to randomization), or shock;
- •· Recent cerebrovascular stroke (within 3 months prior to randomization) or any other life-threatening vascular complication.
研究者
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