ACTRN12616000330448撤回1 期
Phase I/II safety and glycaemic efficacy trial of Deferasirox in patients with type 2 diabetes
Westmead Hospital0 个研究点目标入组 60 人开始时间: 2016年3月14日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 入组人数
- 60
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
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 30 Years 至 75 Years（—）
- 性别
- All
入选标准
- •T2D diagnosed within the last 10 years, with an HbA1c of 7.5%-10%, inclusive. The patients may be treated with diet and exercise or with metformin alone, at a stable dose for the preceding 3 months. After 8 weeks, if their glucose control is not improving, they will be allowed to start other hypoglycaemic medications.
排除标准
- •Age <30 (less likely to be T2DM), or >75 years
- •BMI <25kg/m2, or <23kg/m2 if of South East Asian or Subcontinental Asian ethnicity
- •Body weight >120kg.
- •Elevated serum creatinine outside the normal range or eGFR <60ml/min
- •Anaemia, thrombocytopaenia, iron deficiency or known iron overload conditions
- •Low serum ferritin (<150ng/ml for men or <100ng/ml for women)
- •Any grade of known diabetic retinopathy above mild non-proliferative changes
- •Because of the reported low incidence of cataracts, all patients must have a diabetic eye screen within the preceding year and patients with cataracts will be excluded
- •Microalbuminuria or macroalbuminuria (confirmed on repeat testing), excluded due to the reported rare side effect of Fanconi syndrome
- •Significant proteinuria (confirmed on repeat testing). Defined as a urinary protein:creatinine ratio of >1mg/mg in a mid-stream sample
- •Unstable angina, congestive cardiac failure, stable angina with onset <500m of walking or claudication with onset distance <500m, all due to the small risk of inducing anaemia
- •Pregnancy, breast-feeding or lack of reliable contraception in women of child-bearing age
- •Known malignancy
- •Liver function tests >twice the upper limit of the normal reference range
- •Inability to give informed consent
- •Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the Investigator’s opinion makes it undesirable for the patient to participate in the study, or which would jeopardise compliance with the protocol.
- •Medical co-morbidities that have the potential to be exacerbated by or contra-indicate treatment with deferasirox
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