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临床试验/EUCTR2010-020193-42-GB
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.

研究者

发起方
Hywel DdA Health Borad

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