EUCTR2018-001569-17-NL进行中（未招募）1 期
Effect of the SGLT-2 inhibitor dapagliflozin on impaired awareness of hypoglycemia in type 1 diabetes - Dapagliflozin and impaired awareness of hypoglycemia in T1DM
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 15
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
- •Type 1 diabetes, disease duration >1 year
- •Age >18 years, <75 years
- •BMI 19-30 kg/m^2
- •Insulin treatment according to basal-bolus insulin regimen (injections
- •or insulin pump)
- •Impaired awarenessof hypoglycemia as assessed by a score of 3 or
- •more on the modified Dutch translation of the Clarke questionnaire
- •Glycated haemoglobin (HbA1c) =42 mmol/mol (6%) and =75
- •mmol/mol (9.0%)
- •Ability to provide informed consent
- •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 15
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Known intolerance to SGLT-2 inhibitors (including allergy)
- •Treatment with glucose-modefying or immune-modefying agents, e.g.
- •prednisolon
- •Treatment with pioglitazone
- •History of cardiovascular disease (e.g. myocardial infarction, stroke, heart failure, symptomatic peripheral arterial disease) or hypotension
- •Conditions that can lead to volume depletion (acute gastro-intestinal diseases)
- •History of galactose-intolerance, lactase deficiency, glucose-galactose malabsorption
- •History of diabetic ketoacidosis requiring medical intervention within 1 month before screening
- •Admission to the hospital for hyper- or hypoglycemia <1 month before screening
- •Frequent episodes of severe hypoglycemia <1 month before screening
- •History of laser coagulation for proliferative
- •retinopathy (past 6 months)
- •Proliferative retinopathy
- •Symptomatic diabetic neuropathy
- •Diabetic nephropathy as reflected by albumin-creatinin ratio >30
- •mmol/mg or MDRD <60 ml/min/1.73 m2
- •History of pancreatitis (acute or chronic) or pancreatic cancer
- •Use of premixed insulin or of long-acting insulin alone
- •Total daily insulin dose requirements <20 units unless on pump
- •Pregnancy or unwillingness to undertake measures for birth control
研究者
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