EUCTR2015-005402-11-GB进行中（未招募）1 期
The Impact of the Combination of the GLP-1 Analogue Liraglutide (Victoza®) and Laparoscopic Adjustable Gastric Banding (LAGB) on Diabetes Control - GLIDE: Gastric band and Liraglutide Intervention in Diabetes Evolution
Guys and St Thomas NHS Foundation Trust0 个研究点目标入组 58 人开始时间: 2016年3月18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
- 58
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
入选标准
- •1.Adult patients with type 2 diabetes diagnosed within the last 10 years
- •2.HbA1c =6.5% and <11% at or before screening
- •3.Age 18-70 years
- •4.Patients with a BMI equal to or above 30kg/m2 (or 27.5kg/m2 and of Asian family origin) and less than or equal to 50kg/m2 at screening
- •5.Patients undergoing LAGB based on NICE criteria and multidisciplinary assessment
- •6.Written informed consent to participate.
- •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 58
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 58
排除标准
- •1.Patients with type 1 diabetes (based on clinical history)
- •2.Patients who refuse or are unable to have injectable treatment post operatively
- •3.Patients with any disability preventing use of treatment
- •4.Patients with known delayed gastric emptying
- •5.Patients with a hypersensitivity to liraglutide or any of the excipients listed in the summary of product charateristics; or any limitation to liraglutide use (active at time of screening or likely to be recurrent and/or clinically significant in the future) as per the summary of product characteristics (for example: Inflammatory bowel disease, Diabetic Ketoacidosis, diabetic gastroparesis (based on clinical assessment), severe renal impairment (eGFR < 30mL/min/1.73m2), severe hepatic impairment, acute pancreatitis (persistent, severe abdominal pain) and congestive heart failure NYHA class IV)
- •6.Type 2 diabetes controlled purely through diet unless metformin is contraindicated or not tolerated
- •7.Pregnancy or breastfeeding or planning to become pregnant during the study period and women of childbearing age who are not using adequate contraceptive
- •8.Personal or family history of thyroid cancer or multiple endocrine neoplasia
- •9.History of previous pancreatitis
- •10.Administration of a GLP-1 agonist or DPP-IV inhibitor after surgery.
- •11.Patients who display insufficient understanding of the trial procedures following reasonable attempts by the investigator to provide information, at the discretion of the investigator.
研究者
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已完成
不适用
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