EUCTR2005-004032-48-SE进行中（未招募）不适用
A Randomized, Double-Blind, Placebo-Controlled, Cross-Over Study to Evaluate the Effect of Tesaglitazar 1 mg once daily on the Pharmacokinetics of Metformin Following Addition of Tesaglitazar to Metformin Treatment twice daily in Patients with Type 2 Diabetes
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
- 36
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.Provision of a written informed consent at Visit 1
- •2.Men or women who are =18 years of age at time of consenting upon Visit 1
- •3.Female patients who are post menopausal, have undergone a hysterectomy, or if of childbearing potential, are using an effective method of birth control
- •Post menopausal patients are defined as patients with:
- •-Natural or induced menopause with last menstruation >1 year ago, or
- •-Bilateral oophorectomy
- •A highly effective method of birth control is defined as combination oral contraceptive, implant, long term injectable contraceptive, intrauterine device or tubal ligation. However, female patients using oestrogen containing hormonal anti conception methods (oral, transdermal, vaginal ring or combination injectables) must agree to use an additional anti conception method.
- •4.Diagnosed with type 2 diabetes. For patients <30 years the C-peptide level in conjunction with the onset of diabetes should be >0.8 ng/mL, 0.27 nmol/L.
- •5.FPG =13.3 mmol/L, 240 mg/dL
- •6.Treated with metformin alone for the last three months or more, or treated with metformin for the last three months plus one additional oral anti-diabetic agent in low dose (maximal daily dose of metformin 2.7 g/day). The additional anti-diabetic medication is required to be discontinued at the enrolment visit. The low doses of additional anti-diabetic medication are defined as a maximal daily dose of sulphonylurea comparable to glibenclamide/glyburide 5 mg (corresponding to 3.5 mg of Swedish microcristal form of glibenclamide), meglitinide comparable to repaglinide 1.5 mg or alpha-glucosidase inhibitors comparable to acarbose 150 mg.
- •Inclusion criteria at randomisation (Visit 2):
- •7.HbA1c =8.5 %
- •8.Mean FPG of two measurements (values from Visit 1 and 2, measured capillary) =11.7 mmol/L, 210 mg/dL
- •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.Type 1 diabetes, history of diabetic ketoacidosis, or corticosteroid-induced type 2 diabetes
- •2.Active arterial disease such as unstable angina, myocardial infarction, transient ischemic attack, cerebrovascular accident, myocardial or peripheral vascular disease revascularization or angioplasty within 24 weeks prior to Visit 1
- •3.Pre-existing chronic heart failure (NYHA class I-IV)
- •4.High blood pressure (mean systolic blood pressure =160 mm Hg, mean diastolic blood pressure =90 mm Hg after 3 repeated measurements) with or without anti-hypertensive treatment.
- •5.History of thyroid ophthalmopathy
- •6.History of malignancy within the last 5 years, excluding successful treatment of basal or squamous cell skin carcinoma
- •7.History of blood lipid induced eruptive xanthomas, or hypertriglyceridaemia induced pancreatitis
- •8.Suspected untreated proliferative diabetic retinopathy, as judged by the investigator
- •9.Other conditions predisposing for development of lactatic acidosis, eg, chronic obstructive pulmonary disease (COPD)
- •10.Pregnant or breastfeeding patients
- •11.Suspicion that the patient is infected according to World Health Organisation (WHO) risk categories 2 to 4 (See Appendix C)
- •12.Treatment of type 2 diabetes with combination therapy (ie, additional antidiabetic agents, except low dose of 1 oral antidiabetic agent, see Section 3.4.5)
- •13.Treatment with chronic insulin, within 24 weeks prior to Visit 1 (however, 1 temporary period of daily insulin injections no longer than 7 days is allowed)
- •14.Treatment with a thiazolidinedione (eg, pioglitazone, rosiglitazone) within 4 weeks prior to Visit 1
- •15.Treatment with fibrates, within 4 weeks prior to Visit 1
- •16.Treatment with glucocorticoids (equivalent to oral prednisolone >10 mg per day), within 4 weeks prior to Visit 1
- •17.Treatment with probenecid that can not be stopped at Visit 1
- •18.History of hypersensitivity or intolerance to any PPAR agonist
- •19.History of drug-induced myopathy or drug-induced CK elevation
- •20.History of drug-induced liver enzyme elevations
- •21.History of drug-induced neutropenia
- •22.History of alcohol or drug abuse within the last 5 years
- •23.Other serious or unstable medical or psychological condition identified in the patients’ medical history that, in the judgement of the investigator, would compromise the patients’ safety or successful participation in the Clinical Study
- •24.Receiving any investigational product during the last 12 weeks prior to Visit 1
- •25.Previous enrolment in this study
- •26.Any clinically significant abnormality identified on physical examinations, laboratory tests or ECG, which in the judgement of the investigator would compromise the patients’ safety or successful participation in the Clinical Study
- •27.Other serious or unstable medical or psychological condition identified in the patients’ medical history that, in the judgement of the investigator, would compromise the patients’ safety or successful participation in the Clinical Study
- •28.Fasting TG >7.0 mmol/L, 620 mg/dL
- •29.Hb <90 g/L, 9 g/dL
- •30.ANC <1.0x 109/L
- •31.Any of ALT, AST or ALP >2.5 times the upper limit of normal
- •32.Total bilirubin above the upper limit of normal unless exclusively caused by Gilbert’s syndrome
- •33.Creatinine > 135 µmol/L for men or > 110 µmol/L for women
- •34.Calculated creatinine clearance <50 mL/min (estimated by the Cockcroft-Gault equation)
- •35.CK >3 times the upper limit of normal
- •36.Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or
研究者
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