EUCTR2010-020193-42-GB进行中(未招募)1 期
A comparative study 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 Hypoglycemic Agents (OHA's)+ high doses of insulin. - Liraglutide & Acarbose effect on HbA1c, Wt and HRQOL in type2 Diabetes
Hywel DdA Health Borad0 个研究点目标入组 66 人开始时间: 2010年6月22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
- 66
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
- •Age > 18 years. Male or Female. In addition, patients should fulfil all the following criteria at the randomization visit (visit 0):
- •1.Type – 2 Diabetic patients with suboptimal glycaemic control despite on high doses (1 unit/kg/day OR 100units/day) of insulin.
- •2.(HbA1c = 7.5%).
- •3.BMI = 29
- •4.On, at least: Metformin (= 1.5G/day) + SU (Gliclazide = 240mg/day or Glimepride = 4mg/day).
- •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
- •Previous H/O: M.I. (in last 12months),
- •Congestive Cardiac Failure (NYHA class III or IV),
- •Stage II, III & IV Chronic kidney disease,
- •Abnormal ALT (> 3fold at baseline).
- •Hypoglycaemia unawareness OR recurrent hypos requiring 3rd party assistance.
- •Uncontrolled Hypertension (BP > 180/100mmHg).
- •Pregnant OR likelihood of pregnancy during the study.
- •Patients currently on OR treated in the last 12-months with a glitazone, DPP-IV, GLP analogue, Acarbose, steroides.
- •History of inflammatory bowel disease, previous abdominal surgery, history or presence of intestinal obstruction / Hernia.
- •History of Diabetic ketoacidosis, gasteroparesis and pancreatitis.
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