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临床试验/EUCTR2008-002199-88-SE
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

ovo Nordisk A/S0 个研究点目标入组 800 人开始时间: 2008年9月18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)
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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