EUCTR2006-000924-15-HU进行中（未招募）不适用
A randomized, double-blind study comparing the efficacy and safety of a fixed combination of fenofibrate and metformin vs metformin alone in patients with type 2 diabetes mellitus and dyslipidemia not appropriately controlled with a statin - fenofibrate and metformin fixed combination vs metformin
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 480
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,
- •2. With T2DM treated with stable dose of metformin (500 mg bid, 850 mg bid, 850 mg tid) for a minimum of 3 months, either alone or in combination with another oral hypoglycemic agent (sulfonylurea, meglitinide analogue, or a-glucosidase inhibitor),
- •3. With dyslipidemia not appropriately controlled with a statin treatment and lifestyle recommendations, based on the clinical values of TG and LDL-C in patient medical files (not older than 3 months),
- •4. Treated within the last 3 months with a statin treatment at a dose not exceeding the maximum daily dose authorized in the study i.e. atorvastatin 20 mg - fluvastatin, lovastatin, pravastatin and simvastatin 40 mg - rosuvastatin 10 mg. The statin treatment has to be kept constant throughout the study,
- •5. Having signed a written informed consent.
- •At randomization (V1) the following parameters must comply with:
- •6. 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,
- •7. LDL-C = 130mg/dL (3.35 mmol/L),
- •8. HbA1c = 8.5%
- •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
- •1. Known Type 1 diabetes,
- •2. In cardiovascular secondary prevention,
- •3. Body mass index > 40 kg/m2,
- •4. Women who are not postmenopausal if they are not surgically sterilized, or not using adequate contraceptive precautions,
- •5. Pregnant or lactating women,
- •6. Known hypersensitivity to fibrates, metformin, or any of their components or known photoallergic or phototoxic reactions under treatment with fibrates or ketoprofen,
- •7. Known allergy to peanut or arachis oil or soya lecithin or related products due to the risk of hypersensitivity reactions,
- •8. Having received an investigational drug in the last 30 days before date of inclusion,
- •9. Unable or unwilling to comply with the protocol,
- •10. Likely to withdraw from the study before its completion.
- •Concomitant medications:
- •11. Treated within the last 3 months before inclusion with a lipid-lowering drug other than statins,
- •12. Treated within the last 3 months before inclusion with thiazolidinedione, insulin, fixed-dose formulations of 2 oral antihyperglycemic drugs including metformin
- •13. Change within the last month before inclusion, and during the course of the study, in the medications that could interfere with the lipid or glycemic profile,
- •14. Treated within the last month before inclusion with cyclosporin A, and any other immunosuppressive agent, with protease inhibitors, for obesity by medical treatment and/or surgery.
- •Associated diseases or conditions:
- •15. Diabetic ketoacidosis, diabetic pre-coma,
- •16. Current chronic pancreatitis, or identified risk or known history of acute pancreatitis,
- •17. Known cholelithiasis without cholecystectomy,
- •18. Significant hepatic disease: AST and/or ALT > 2 times the upper limit of normal (ULN),
- •19. Musculoskeletal disease with increased creatine phosphokinase (CPK) > 3 times ULN,
- •20. 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,
- •21. Acute conditions with the potential to alter renal function,
- •22. Cardiac or respiratory failure or any acute or chronic disease which may cause tissue hypoxia,
- •23. 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),
- •24. Other uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins,
- •25. Patients particularly susceptible to hypoglycemic effects, such as debilitated, or malnourished patients, acute alcohol intoxication, excessive alcohol intake,
- •26. Known gastric or peptic ulcer or intestinal disease within the previous 3 months of randomization capable of modifying the intestinal absorption of the drugs,
- •27. Any other severe pathology such as cancer or mental illness or degenerative disease that would limit study evaluation or participation.
- •In addition in patients aged under 35 years the following exclusion criteria will apply
- •28. Body mass index < 25 kg/m2,
- •29. Ever been treated by Insulin,
- •30. Family history of type 1 diabetes.
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