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临床试验/ACTRN12611000992909
ACTRN12611000992909撤回4 期

The effect of Galvus (vildagliptin) on post-prandial endothelial function and post-prandial hypertriglyceridaemia in individuals with Type 2 diabetes and fasting hypertriglyceridaemia, treated with statins.

Associate Professor Seng Khee Gan0 个研究点目标入组 20 人开始时间: 2011年9月16日最近更新:
适应症

试验速览

阶段
4 期
状态
撤回
发起方
入组人数
20

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Blinded (masking used)

入排标准

年龄范围
18 Years 至 o limit(—)
性别
All

入选标准

  • Outpatients with Type 2 diabetes on metformin treatment only (at doses 500mg to 1000mg twice daily).
  • HbA1c < 8%.
  • Already treated with a statin for at least 6 weeks with LDL cholesterol<2.5 mmol/L.
  • Hypertriglyceridaemia (Triglycerides > 1.7 mmol/L) on a random blood sample.

排除标准

  • Treatment with other oral diabetes medications other than metformin.
  • Treatment with insulin or exenatide.
  • HbA1c > 8%.
  • Treatment with fibrates.
  • Premenopausal females. Menopause is defined as 12 consecutive months without menstruation. If menopausal status is in question, a follicle-stimulating hormone (FSH) level of > 30 mIU/ml must be documented.
  • Primary dyslipidaemia, including the E2/E2 genotype.
  • Type III dyslipedaemia.
  • Uncontrollable hypertension: resting BP > 150/90.
  • Consumption of > 30g alcohol per week.
  • Tobacco smoking.
  • Significantly abnormal liver function (ALT or AST > 3 times ULN).
  • Creatine kinase > 3 x ULN.
  • Creatinaemia (> 150 micromols).
  • Macroproteinuria.
  • Significantly abnormal thyroid function.
  • Atrial fibrillation or significant dysrythmia.
  • Cardiovascular event in the last 6 months.
  • Gastric disorders.
  • Any other serious medical / systemic illness (e.g cancer).
  • Use of steroids or other medications that may affect lipid metabolism.
  • Psychiatric illness.
  • Allergies to eggs, cream, milk.
  • Likelihood of poor compliance to the study.
  • Likelihood of not completing the study.

研究者

发起方
Associate Professor Seng Khee Gan

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