EUCTR2011-000411-12-NL进行中（未招募）1 期
The effect of Liraglutide on insulin-associated weight gain in patients with type 2 diabetes - Liraglutide and weight gain
MC St Radboud0 个研究点目标入组 80 人开始时间: 2011年11月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
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 on short-term insulin therapy
- •(= 12 months); all types of insulin allowed
- •-Insulin-associated weight gain = 3.0 kg from the start of insulin therapy
- •-Age 18-75 years
- •-BMI = 25 kg/m2
- •-Stable glycaemic control mirrored by HbA1c = 6.5 and = 8.5 %
- •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 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •-Inability to provide informed consent
- •-Type 1 diabetes mellitus, MODY diabetes, or LADA diabetes
- •-Presence of any medical condition that might interfere with the current
- •study protocol.
- •-Inflammatory bowel disease (e.g. M. Crohn, ulcerative colitis)
- •-Recurrent hypoglycaemic events
- •-Diabetic gastroparesis
- •-Heart failure (LVEF = 30%)
- •-Use of TZDs (glitazones), DDP-IV (dipeptidylpeptidase-inhibitor)
- •-Use of medication associated with impaired glucose metabolism including
- •corticosteroids
- •-Pregnancy or breast-feeding (contraception of at least 3 months before
- •inclusion is required for fertile women)
- •-Pre-existing thyroid disease
- •-Liver disease (aspartate aminotransferase or alanine aminotransferase
- •level of more than three times the upper limit of normal range)
- •-Renal disease (creatinine > 130 µmol/l or MDRD-GFR <30 ml/min/1.73m2)
研究者
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