EUCTR2009-012270-12-HU进行中（未招募）不适用
Effects of 150 µg aleglitazar on renal function in patients with Type 2 diabetes and moderate renal impairment, as compared to Actos®
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
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
- •1. Age = 18 years at screening visit.
- •2. Males and females diagnosed with T2D, based on the WHO criteria, for at least 1 month before screening visit.
- •3. Drug naïve status, or treatment with either monotherapy or a combination therapy of antihyperglycemic medication (stable = 1 month at screening visit; not more than two combined treatments).
- •4. HbA1c 6.5 - 10.0 % (inclusive) at screening visit.
- •5. FPG = 240 mg/dL (13.3 mmol/L) at screening visit.
- •6. eGFRMDRD = 30 and < 60 mL/min/1.73m2 at screening visit.
- •7. UACR = 3000 µg/mg at screening visit.
- •8. BMI from 25.0 kg/m2 (Asian patients: from 23.0 kg/m2) to 35.0 kg/m2.
- •9. Able and willing to give written informed consent and to comply with the requirements of the study.
- •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. Current or previous treatment with a thiazolidinedione (e.g. medications containing pioglitazone or rosiglitazone, like Actos®, Avandia®, ActoplusMet™, Avandamet®, Avandaryl™), another PPAR ? agonist, or a dual PPAR a/?
- •2. Current or previous treatment with insulin (with the exception of emergency cases in which insulin is given for < 7 consecutive days).
- •3. Treatment with fibrates in the 3 months preceding screening visit.
- •4. Treatment with statins in the last month before screening, except STABLE and not likely to require changes during the study.
- •5. Treatment with medications interfering with measurement of creatinine (e.g. cimetidine, trimethoprim, probencid, sulfonamides, procaine or thiazolesulfone).
- •6. Chronic therapy with NSAIDs (except prophylactic STABLE low dose aspirin in the last month before screening; dose not higher than 100 mg daily; paracetamol/acetaminophen is allowed).
- •7. Antihypertensive therapy in the last 3 months before screening, except STABLE, and not likely to require changes during the study.
- •8. Known diagnosis of renal disease other than diabetic nephropathy (e.g. polycystic kidney disease, kidney transplant, kidney cancer).
- •9. Systemic corticosteroid therapy within 3 months prior to screening visit.
- •10. Uncontrolled hypertension (SBP > 140 mmHg and/or DBP > 90 mmHg despite anti-hypertensive drug therapy; mean of two readings) at screening visit.
- •11. Impaired liver function (ALT or AST > 3 × ULN) at screening visit.
- •12. Creatine phosphokinase (CPK) elevated > 3 × ULN at screening visit.
- •13. History of drug induced myopathy.
- •14. Hemoglobin < 11 g/dL at screening visit [continuous erythropoiesis-stimulating agent (ESA) treatment is allowed].
- •15. Congestive heart failure classified NYHA class II to IV at or prior to screening or randomization visit.
- •16. Peripheral edema above the ankle level at the screening or randomization visit.
- •17. Myocardial infarction, acute coronary syndrome or transient ischemic attack/stroke within 6 months prior to screening.
- •18. Vascular or cardiac surgery within 6 months prior to the screening visit.
- •19. Known macular edema at or prior to screening visit.
- •20. Planned major surgery during the course of the study.
- •21. Any serious illness (such as metastatic cancer, major active infection, severe psychiatric disorders) at screening visit.
- •22. Any other significant medical condition which would not allow participation in this study at the judgment of the investigator.
- •23. Positive pregnancy test, breastfeeding women and women not using an adequate method of contraception.
- •24. Participation in any clinical trial with an investigational drug within three months prior to the screening visit.
研究者
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