EUCTR2008-006860-12-DE进行中（未招募）不适用
Comparative investigation of Insuline glargine versus Metformin as first line drug in treat-ment of early Type 2 Diabetes (GLORY) - GLORY
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- GWT-TUD GmbH
- 入组人数
- 100
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
- •- Patients with Type II Diabetes mellitus (less than 5 years)
- •- Age between 35 and 75
- •- HbA1C > 6,5% < 8,0% (8,5% if previously treated with OAD (oral antidiabetikum))
- •- Signed informed consent form
- •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
- •- Treatment with more than one OAD
- •- Treatment with 1 OAD within the last 6 weeks
- •- Treatment with insuline
- •- History of cardiovascular disease < 6 months
- •- Significant hepatic disease (ALAT/ASAT> 2,5 times of normal range) or alcohol
- •intoxication
- •- Significant renal diseases (Kreatinin >1,2 mg/dl or Kreatinin-Clearance<60ml/min)
- •- Circumstances which can cause renal insufficiency, e.g. dehydration, severe
- •infections, shock
- •- Treatment with systemic, oral or injectable Corticosteroids
- •- Diseases of the adrenal gland, hypophysis, thyroid gland, which are not appropriate
- •for the study procedure (investigators estimation)
- •- Intravascular administration of contrast agents containing iodine
- •- Diabetic ketoacidosis
- •- Acute or chronic diseases that can cause tissue hypoxie like cardiac or respiratory
- •insufficiency, myocardic infarct, shock
- •- Known allergic or hypersensitiv reaction to one of the study drug or to drugs with
- •similar chemical structures
- •- Lack of compliance or other similar reason, that according to investigator, precludes
- •satisfactory participation of the study
- •- Participation in another clinical trial within the last 4 weeks
- •- History of drug or alcohol abuse or psychological sickness that does not allow the
- •subject to understand the nature and procedures of the study
- •- Pregnant and lactating women
- •- Women of childbearing potential not actively and consistently practicing birth control
- •by using a medically accepted device or therapy (error rate <1%)
研究者
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