EUCTR2005-004798-60-DE进行中（未招募）不适用
A one-year multicentre, international, randomised, double-blind study with comparison of benfluorex (150 mg od to 150 mg tid) versus pioglitazone (30 mg od to 45 mg od) in combination with sulfonylurea administered orally for the treatment of type 2 diabetes.
I.R.I.S. Institut de Recherches Internationales Servier0 个研究点目标入组 840 人开始时间: 2006年2月3日最近更新:
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
- 840
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
- •- Male or female aged >=35 years and =< 80 years,
- •- BMI between 25 and 40 kg/m2 (inclusive),
- •- out-patients with type 2 diabetes,
- •- in monotherapy with a sulfonylurea at stable dose for at least 3 consecutive months prior to the selection visit and at dose >= 50% of the maximal recommended one,
- •- HbA1c between 7% and 10% inclusive.
- •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
- •- Known Latent Autoimmune Diabetes in Adults,
- •- Type 2 diabetes treated in the previous 3 months with an oral hypoglycaemic agent other than a sulfonylurea,
- •- Type 2 diabetes treated with more than 1 oral hypoglycaemic agent in the previous 3 months,
- •- Insulin treatment in the previous year, except short term treatment for exceptional reason such as surgery
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