EUCTR2004-002036-25-HU进行中（未招募）不适用
Comparison of three therapeutic strategies for treating type 2 diabetes mellitus patients poorly controlled with basal insulin associated with oral antidiabetic drugs. - OSIRIS
ABORATOIRE AVENTIS0 个研究点目标入组 776 人开始时间: 2005年4月15日最近更新:
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
- 入组人数
- 776
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
- •- Type 2 diabetic men or women
- •- Aged 18 to 75 years
- •- BMI £ 40 kg/m2
- •- 7% < HbA1c £ 11%
- •- Treated with basal insulin (NPH, Insulin Zinc, insulin glargine or insulin detemir), and at least, two OAD including a sulfonylurea (at a dosage ³ 50% of the maximum recommended dosage) and metformin (at the maximum tolerated dosage), for more than 6 months
- •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 mellitus
- •- Treatment with OADs only
- •- Treatment with thiazolidinediones or glinides
- •- Treatment with an insulin other than basal insulin (Premix, rapid insulin, fast-acting insulin analogue)
- •- Active proliferative diabetic retinopathy, as defined by the application of photocoagulation or surgery, in the 6 months before study entry or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgery during the study (confirmed by an optic fundus performed in the 2 years prior study entry)
- •- Pregnancy (women of childbearing potential must have a negative pregnancy test at study entry and effective contraception)
- •- Breast-feeding
- •- Treatment with systemic corticosteroids, irrespective of the dose of administration and irrespective of the prior or foreseeable treatment duration
- •- Treatment with any investigational product in the last 2 months before study entry, except for insulin glargine
- •- Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major disease making implementation of the protocol or interpretation of the study results difficult
- •- Impaired hepatic function as shown by ALT and/or AST greater than three times the upper limit of normal at study entry
- •- Impaired renal function as shown by serum creatinine >135 µmol/l in men and > 110 µmol/l in women at study entry
- •- History of drug or alcohol abuse
研究者
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