ACTRN12620000201976已完成1 期
GLP-1 for lowering plasma glucose in type 2-diabetic patients: A systematic comparison of intravenous and subcutaneous routes.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
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 75 Years（—）
- 性别
- All
入选标准
- •Male and females aged 18 to 75 years (both included)
- •- Diagnosis of T2DM by ADA criteria
- •- Diabetes treatment for greater or equal to 3 months with:
- •* Basal insulin (glargine) or premixed insulin (e.g. Mixtard or Novomix),
- •* together with any combination of diet, metformin, sulfonylurea, thiazolidinedione, SGLT2 inhibitor, alpha-glucosidase inhibitor, or prandial insulin.
- •- Body mass index (BMI) 20 to 35 kg/m² (both included)
- •- Weight-stable ( less than or equal to 3% change in last 3 months)
排除标准
- •- Use of insulin degludec (due to its very long half-life)
- •- Use of a DPP-4 inhibitor or GLP-1RA
- •- Patients with diagnosis of T1DM (based on islet autoantibodies)
- •- Patients with possible diabetes mellitus caused by diseases of the exocrine pancreas T3cDM (based on a history of alcohol intake greater or equal to 3 units daily, pancreatic disease, or steatorrhea)
- •-Impaired renal (eGFR less than 60mL/min as calculated by CKP-EPI formula) or liver function (transaminases more than or equal to 2 x ULN), iron deficiency (serum ferritin less than 20 µg/l) or anaemia (ie. haemoglobin less than 135g/L for men and less than 115g/L for women)
- •- Patients with contraindications to bilateral IV cannulation: history of mastectomy, axillary node clearance, axillary node radiotherapy, upper limb lymphedema and upper limb arteriovenous fistula for haemodialysis.
- •- Symptomatic ischaemic heart disease
- •- Pregnancy (pre-menopausal females will be using adequate contraception and record a negative pregnancy test on each study day)
- •- Patients with significant gastrointestinal (GI) symptoms (any upper GI symptom moderate” or worse on the PAGI- SYM questionnaire)
- •- Previous GI surgery (other than appendicectomy or cholecystectomy)
- •- HbA1c less than 7.0%
- •- Evidence of drug abuse, consumption of more than 20 g alcohol or 10 cigarettes daily
- •- Other significant illness, including epilepsy, cardiovascular or respiratory disease
- •- Donation of blood within the previous 12 weeks
- •- Participation in any other research studies within the previous 3 months
- •- Inability to give informed consent
- •- Vegetarians
研究者
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