EUCTR2005-006060-63-NL进行中（未招募）1 期
A randomized, double-blind trial comparing the efficacy and safety of a fixed combination of fenofibrate and metformin vs rosiglitazone in patients with type 2 diabetes mellitus and dyslipidemia - fenofibrate and metformin fixed combination vs rosiglitazone
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 690
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
- •At inclusion (V0):
- •1. Male or female aged from 18 to 75 years old,
- •2. With type 2 diabetes mellitus and dyslipidemia inadequately controlled with lifestyle modifications (diet and exercise),
- •3. With antidiabetic drug status as follows:
- •Antidiabetic drug naive patients: who have never been on prior antidiabetic drug treatment,
- •Antidiabetic drug free patients: who have not received antidiabetic drug treatment in the last 6 months,
- •4. Having signed a written informed consent.
- •At randomization (V1):
- •5. FPG = 126 mg/dL dL (= 7.0 mmol/L) and < 300 mg/dL (< 16.7 mmol/L). Glycemic status of the patients will be confirmed based on two FPG assays, BV0 and BV1,
- •6. HbA1c = 6.5% and = 9.5%,
- •7. Hypertriglyceridemia with or without hypercholesterolemia, defined by TG = 150 mg/dL and = 400 mg/dL (TG = 1.69 mmol/L and = 4.52 mmol/L), assayed at BV1.
- •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
- •Patient with any of the following conditions will not be included in the trial:
- •1. Known Type 1 diabetes,
- •2. With LDL-C > 130mg/dL (3.35 mmol/L),
- •3. In cardiovascular secondary prevention,
- •4. Body mass index > 40 kg/m2,
- •5. Women who are not postmenopausal if they are not surgically sterilized (i.e. bilateral tubal ligation, bilateral or two unilateral oophorectomies, hysterectomy), or not using adequate contraceptive precautions,
- •6. Pregnant or lactating women,
- •7. Known hypersensitivity to fibrates, metformin, rosiglitazone or any of their components or known photoallergic or phototoxic reactions under treatment with fibrates or ketoprofen,
- •8. Known allergy to peanut or arachis oil or soya lecithin or related products due to the risk of hypersensitivity reactions,
- •9. Having received an investigational drug in the last 30 days before date of inclusion,
- •10. Unable or unwilling to comply with the protocol and the standard diet and exercise recommendations,
- •11. Likely to withdraw from the study before its completion.
- •Concomitant medications:
- •12. Treated within the last 6 months before randomization with any antidiabetic drug treatment,
- •13. Treated within the last 2 months before randomization with a lipid-lowering drug (except statins). Patients who were on a statin before inclusion may be included provided the dose does not exceed the maximum daily dose authorized in the study ) and is kept constant throughout the study.
- •14. Treated within the last 2 months before randomization with cyclosporin A, and any other immunosuppressive agent, with protease inhibitors (indinavir, ritonavir, saquinavir, …), for obesity by medical treatment (orlistat, sibutramine…) and/or surgery (gastroplasty, bypass,…), with rifampin (inducer of CYP2C8)
- •15. Change within the last 2 months before randomization, and during the course of the study, in the medications that could interfere with the lipid or glycemic profile.
- •Associated diseases or conditions:
- •16. Diabetic ketoacidosis, diabetic pre-coma,
- •17. Current chronic pancreatitis, or identified risk or known history of acute pancreatitis,
- •18. Known cholelithiasis without cholecystectomy,
- •19. Significant hepatic disease: AST and/or ALT > 2 times the upper limit of normal (ULN),
- •20. Musculoskeletal disease with increased creatine phosphokinase (CPK) > 3 times ULN,
- •21. Renal failure or renal dysfunction defined by a creatinine clearance < 60 mL/min as calculated with the Cockroft-Gault algorithm: creatinine clearance = [(140 - age) x weight (kg) / 7.2 x serum creatinine (mg/L)] for males and [x 0.85] in females,
- •22. Acute conditions with the potential to alter renal function (such as dehydration, severe infection, shock, intravascular administration of iodinated contrast agents),
- •23. Acute or chronic disease which may cause tissue hypoxia such as respiratory failure,
- •24. Known congestive heart failure or past medical history of congestive heart failure (class I to IV),
- •25. Known abnormal thyroid hormone levels, or high thyroid stimulating hormone (TSH) level. (clinically euthyroid subjects on stable replacement doses of thyroid hormone are eligible for inclusion),
- •26. Other uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins,
- •27. Patients particularly susceptible to hypoglycemic effects, such as debilitated, or malnourished patients, acute alcohol intoxication, excessive alcohol intake,
- •28. Known gastric or peptic ulcer or intestinal disease within the previous 3 months of
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