ISRCTN47355247已完成4 期
An open label, randomised controlled trial of the effects of Liraglutide and Acarbose on glycaemic control, weight and Health Related Quality Of Life (HRQOL) in Overweight type 2 Diabetic patients on Oral Hypoglycaemic Agents (OHAs) and high doses of insulin
West Wales Hospital (UK)0 个研究点目标入组 66 人开始时间: 2010年8月31日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 66
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Age > 18 years
- •2. Male or female
- •In addition, patients should fulfil all the following criteria at the randomization visit (visit 0):
- •3. Type II Diabetic patients with suboptimal glycaemic control despite on high doses (1 unit/kg/day OR 100units/day) of insulin
- •4. Glycated Haemoglobin (HbA1c) = 7.5%
- •5. Body Mass Index (BMI) = 29
- •6. On, at least: Metformin ( = 1.5G/day) and Sulfonylureas (SU) (Gliclazide = 240mg/day or Glimepride = 4mg/day)
排除标准
- •1. Previous history of: Myocardial infarction (MI) (in last 12 months)
- •2. Congestive Cardiac Failure (New York Heart Association [NYHA] class III or IV)
- •3. Stage II, III & IV Chronic kidney disease
- •4. Abnormal Alanine Aminotransferase (ALT) (> 3fold Upper Limit of Normal [ULN] at baseline)
- •5. Hypoglycaemia unawareness OR recurrent hypos requiring 3rd party assistance
- •6. Uncontrolled Hypertension (Blood Pressure [BP] > 180/100mmHg)
- •7. Pregnant OR likelihood of pregnancy during the study
- •8. Patients currently on OR treated in the last 12-months with a glitazone, Dipeptidyl Peptidase IV (DPP-IV), Glucagon-Like Peptide (GLP) analogue, acarbose or steroids
- •9. History of inflammatory bowel disease, colonic ulceration, previous abdominal surgery, history or presence of intestinal obstruction / hernia
- •10. Predisposition to intestinal obstruction
- •11. History of Diabetic ketoacidosis, gasteroparesis and pancreatitis
- •12. Females lactating or breastfeeding
- •13. History of allergic reaction or hypersensitivity to Liraglutide, Acarbose or insulin
- •14. Age more than 75 years
- •15. Type-1 Diabetes mellitus
- •16. History of thyroid cancer
- •17. Patients currently on Warfarin
- •18. Patients on sulphonylureas other than Gliclazide or Glimepride
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