EUCTR2012-002649-39-DE进行中（未招募）不适用
A SINGLE-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE II STUDY TO ASSESS THE EFFICACY OF ALEGLITAZAR ON INSULIN SENSITIVITY IN PATIENTS WITH TYPE 2 DIABETES MELLITUS (T2D) WHO ARE INADEQUATELY CONTROLLED WITH METFORMIN MONOTHERAPY
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •Adult patients with type 2 diabetes, 30-70 years of age, treated with stable metformin therapy for at least 12 weeks
- •HbA1c = 6.5% and = 9% and fasting plasma glucose = 13.3 mmol/L (= 240 mg/dL)
- •Overweight (BMI = 25)
- •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 95
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •Type 1 diabetes
- •Previous treatment with a thiazolidinedione or dual PPAR agonist; prior intolerance to fibrate
- •Treatment with any anti-diabetes medication other than stable dose metformin within the last 12 week
- •Treatment any body weight lowering or lipoprotein-modifying therapy (eg, fibrates) within 12 weeks with the exception of statin therapy
- •History of bariatric surgery
- •Estimated glomerular filtration rate <60mL/min/1.73m2
- •Symptomatic congestive heart failure classified as NYHA class II-IV
研究者
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