EUCTR2020-003715-94-CZ进行中（未招募）1 期
INSULIN THERAPY DE-INTENSIFICATION WITH iGlarLixi - IDEA
Institute for Clinical and Experimental Medicine0 个研究点目标入组 100 人开始时间: 2020年10月2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
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Type 2 diabetes mellitus
- •Intensive insulin therapy with at least 3 doses of prandial insulin and one dose of basal insulin/day for at least 3 months prior to screening
- •Total daily insulin dose = 0.8 IU/kg
- •Fasting C peptide above the lower limit of the normal range
- •Treatment with metformin (unless intolerance to metformin use is present)
- •HbA1c = 75 mmol/mol (9%)
- •HbA1c 76-86 mmol/mol (9.1-10%) in case of proven non-compliance with MDI regimen
- •Age 18-80 years
- •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 70
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •Other diabetes types – type 1, secondary
- •Any contraindication to the use of GLP-1 receptor agonists
- •Daily dose of basal insulin >50 units/day
- •Acute myocardial infarction, unstable angina pectoris, stroke, pulmonary embolism 3 months prior to inclusion
- •Chronic heart failure NYHA III-IV
- •Chronic kidney disease CKD IIIb-IV, end-stage renal disease
- •Acute or chronic liver failure
- •Clinically significant gastroparesis
- •Active malignancy
- •Haemoglobin < 100 g/l
- •Pregnancy, breast-feeding, or in case of women with child-bearing potential willingness to be pregnant
研究者
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