EUCTR2008-002199-88-ES进行中（未招募）不适用
Efecto de liraglutida en el peso corporal en sujetos con sobrepeso u obesos con diabetes tipo 2. Ensayo clínico de 1 año de duración, aleatorizado, doble-ciego, controlado con placebo, con tres grupos paralelos, multicéntrico, multinacional, con un periodo de seguimiento observacional de 12 semanas.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,600
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
- •1. Informed consent obtained before any trial-related activities (trial related activities are any procedure that would not have been performed during the normal management of the subject)
- •2. Subjects diagnosed with type 2 diabetes and treated with either diet and exercise alone, metformin, sulphonylurea, glitazone as single agent therapy or a combination of the previously mentioned compounds. Treatment should have been stable for at least 3 months prior to screening
- •3. HbA_1c 7.0-10.0% (both inclusive)
- •4. Body Mass Index (BMI) = 27.0 kg/m^2
- •5. Stable body weight (less than 5 kg self-reported change during the previous 3 months)
- •6. Preceding failed dietary effort
- •7. Age 18 years and above (or as allowed according to local labelling for metformin and sulphonylurea treatment)
- •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
- •Key exclusion criteria:
- •Treatment with glucagon-like peptide-1 (GLP-1) receptor agonists, dipeptidyl peptidase-4 (DPP-4) inhibitors or insulin within the last 3 months
- •Known proliferative retinopathy or maculopathy
- •History of acute or chronic pancreatitis
- •Obesity induced by drug treatment
- •Use of approved weight lowering pharmacotherapy
- •Previous surgical treatment of obesity
- •History of major depressive disorder or suicide attempt
- •Uncontrolled hypertension (systolic blood pressure = 160 mmHg and/or diastolic blood pressure = 100 mmHg)
研究者
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