EUCTR2016-002910-38-DK进行中（未招募）1 期
Basal-bolus insulin therapy with Insulin Degludec and insulin Aspart versus standard therapy for the inpatient management of type 2 diabetes: The IDA2 study - The IDA2 study
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
- 100
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
- •History of type 2 diabetes for at least 6 months
- •Age 18 – 90 years
- •Pre-meal plasma glucose in the range 10 – 22,2 mmol/L prior to inclusion
- •Expected hospital stay longer than 4 days (after inclusion into the trial)
- •Signed 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 100
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Hyperglycemia without known history of type 2 diabetes
- •Type 1 diabetes mellitus
- •Severely impaired renal function (eGFR = 30 mL/min/1,73 m2)
- •Severe hepatic disease
- •Cardiac disease defined as: Decompensated heart failure (NYHA class III-IV) and/or diagnosis of unstable angina pectoris and/or myocardial infarction within the last 6 months
- •Pregnant or lactating women or fertile female patients not using chemical, hormonal or mechanical contraceptives or not in menopause (i.e. must not have had regular menstrual bleeding for at least one year)
- •Planned treatment during hospital stay with intravenous glucose/ insulin for = 12 hours
- •Treatment at admission or planned treatment during hospital stay with parenteral nutrition or enteral nutrition (i.e. gastroenteric tube feeding)
- •Treatment at admission or planned treatment during hospital stay with high dose glucocorticoids (= 25 mg)
- •History or presence of malignancy (except basal skin cancer) unless a disease-free period exceeding five years
- •Presence of alcohol or drug abuse
- •Inability to understand the written information or incapability to provide informed consent
- •Known or suspected hypersensitivity to trial product(s) or related products.
- •Other concomitant medical or psychological conditions that according to the investigator´s assessment makes the patient unsuitable for study participation
- •Previous participation in this trial
研究者
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