EUCTR2004-004374-90-CZ进行中（未招募）不适用
A 24-Week Randomized, Double-Blind, Parallel-Group, Multi-Centre, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of Tesaglitazar Therapy when Administered as Monotherapy to Drug-Naïve Patients with Type 2 Diabetes - GALLANT 22
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 475
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
- •Provision of a written informed consent at visit 1.
- •Men or women who are 18 years of age or more at time of consenting upon visit 1.
- •Female patients post menopausal, hysterectomized or if of childbearing potential using a reliable method of birth control...
- •Diagnosed with type 2 diabetes.
- •Drug-naïve (ie, no use of antidiabetic drug(s), for at least 24 weeks prior to visit 1). However, one temporary period of daily insulin injections no longer than 7 days during this period is allowed.
- •For patients <30 years old C-peptide level has to be >0.8 ng/mL, 0.26 nmol/L.
- •HbA1c 7% up to or equal of 10%. NB Enrolment will be stopped when the cohort of patients having HbA1c more or equal to 7% and less or equal to 7.4% is approximately 25% or the cohort of patients having HbA1c more or equal to 7.5% and less or equal to 10% is approximately 75%.
- •FPG less than or equal to 13.3 mmol/L, 240 mg/dL.
- •Inclusion criteria at randomization (visit 5, laboratory values from visit 3 and 4):
- •HbA1c 7 % up to or equal of 10% (laboratory value from visit 4).
- •Mean FPG of two measurements (laboratory values from visit 3 and 4) less or equal of 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
- •Type 1 diabetes, history of diabetic ketoacidosis, or corticosteroid-induced type 2 diabetes.
- •Active arterial disease such as unstable angina...
- •NYHA heart failure Class III or IV, or unstable Class I or II...
- •History of thyroid ophthalmopathy.
- •History of malignancy within the last 5 years...
- •History of blood lipid induced eruptive xanthomas or hypertriglyceridemia induced pancreatitis.
- •Pregnant or breastfeeding patients.
- •Suspicion that the patient is infected according to WHO risk categories 2 to 4...
- •Treatment with fibrates, within 4 weeks prior to visit 1.
- •Treatment with glucocorticoids (equivalent to oral prednisolon >10 mg per day), within 4 weeks prior to visit 1.
- •Treatment with probenecid that cannot be stopped at visit 1.
- •History of hypersensitivity or intolerance to any PPAR-agonist.
- •History of drug-induced myopathy or drug-induced CK elevation.
- •History of drug-induced liver enzyme elevations.
- •History of drug-induced neutropenia.
- •History of alcohol or drug abuse within the last 5 years.
- •Other serious or unstable medical or psychological condition...
- •Receiving any investigational product within 12 weeks prior to visit 1.
- •Previous enrolment in this study.
- •Involvement in the planning and conduct of the Clinical Study (applies to both AstraZeneca staff and staff at the investigational site).
- •Exclusion criteria at placebo run-in (visit 2, laboratory values from visit 1)
- •Fasting TG >7.0 mmol/L, 620 mg/dL.
- •Hb <90 g/L, 9 g/dL.
- •ANC <1.0 x 1 000 000 000/L.
- •Total bilirubin above the upper limit of normal unless exclusively caused by Gilbert’s syndrome.
- •Creatinine >2 times the upper limit of normal.
- •CK >3 times the upper limit of normal.
- •High BP (mean diastolic BP >120 mm Hg) or malignant hypertension.
- •Hb <90 g/L, 9 g/dL.
- •ANC <1.0 x 1 000 000 000/L.
- •Any of ALT, AST or ALP >2.5 times the upper limit of normal.
研究者
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