PER-032-04已完成未知
ESTUDIO MULTICENTRICO, DOBLE CIEGO, CONTROLADO CON PLACEBO, ALEATORIZADO SOBRE SEGURIDAD DE TAK 559 EN EL TRATAMIENTO DE PACIENTES CON DIABETES MELLITUS TIPO 2
TAKEDA PHARMACEUTICALS,0 个研究点目标入组 0 人开始时间: 2004年5月31日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 0（—）
入选标准
- •Had type 2 diabetes mellitus using American Diabetes Association diagnostic criteria, currently treated with insulin therapy.
- •Required sponsor approval if older than 65 years.
- •Had a Screening glycosylated hemoglobin less than or equal to 8.0%.
- •Had a Screening fasting plasma glucose less than or equal to 200 mg/dL (11.1 mmol/L).
- •Had a Screening low density lipoprotein less than or equal to 160 mg/dL (4.1 mmol/L).
- •Had a Screening thyroid stimulating hormone level less than or equal to 5.5 μU/mL (5.5 μU/L) and greater than or equal to 0.35 μU/mL (0.35 μU/L).
排除标准
- •Had a hypersensitivity to peroxisome proliferator-activated receptor -alpha or gamma agonists, thiazolidinediones, or fibrates.
- •Was diagnosed with type 1 diabetes mellitus or hemochromatosis, or had a history of ketoacidosis.
- •Required greater than 2 hypertension medications to achieve adequate blood pressure control.
- •Had a history of coronary angioplasty or bypass graft, or unstable angina pectoris within 1 year of Screening.
- •Had a history of myocardial infarction.
- •Had a history of transient ischemic attack or documented cerebrovascular accident within 6 months of Screening.
- •Abdominal, thoracic, or vascular surgery within 6 months of Screening warranting exclusion (investigator´s opinion).
- •Had a screening creatine phosphokinase value greater than 3 times the upper limit of normal.
- •Had persistent unexplained microscopic or macroscopic hematuria or history of bladder cancer.
- •Had a screening triglyceride level greater than 500 mg/dL (5.6 mmol/L).
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