EUCTR2008-002199-88-SE进行中(未招募)不适用
Effect of liraglutide on body weight in overweight or obese subjects with type 2 diabetesA 56 week randomised, double-blind, placebocontrolled, three armed parallel group, multi-centre, multinational trial with a 12 week observational follow-up period - SCALE™ - Diabetes
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
- •Informed consent obtained
- •Subjects diagnosed with type 2 diabetes and treated with either diet and exercise alone, metformin, SU, glitazone as single agent therapy or any combination of the previously mentioned compounds (metformin+SU, metformin+glitazone, SU+glitazone, metformin+SU+glitazone)
- •HbA1c 7.0-10.0% (both inclusive)
- •Body Mass Index (BMI) = 27.0 kg/m2
- •Stable body weight
- •Preceding failed dietary effort
- •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 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)
- •Screening calcitonin = 50 ng/L
- •Familial or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (FMTC)
- •Personal history of non-familial medullary thyroid carcinoma
研究者
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