EUCTR2010-023770-39-PT进行中（未招募）不适用
6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin glargine and Lantus® both in combination with oral antihyperglycemic drug(s) in Patients with Type 2 Diabetes Mellitus with a 6 month Safety Extension Period
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 800
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 2 diabetes mellitus
- •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 600
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 200
排除标准
- •o Age <18 years;
- •o HbA1c <7.0% or >10% at screening;
- •o Diabetes other than type 2 diabetes mellitus;
- •o Less than 6 months on basal insulin treatment together with oral antihyperglycemic drugs and self-monitoring of blood glucose;
- •o Patients using sulfonylurea in the last 2 months before screening visit;
- •o Any contraindication to use of insulin glargine as defined in the national product label;
- •o Use of insulin pump in the last 6 months before screening;
- •o Initiation of new glucose-lowering medications in the last 3 months before screening visit;
- •o History or presence of significant diabetic retinopathy or macular edema likely to require laser or injectable drugs or surgical treatment during the study period;
- •o Pregnant or breast-feeding women or women who intend to become pregnant during the study period
研究者
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