Basal-bolus Insulin Therapy With Insulin Degludec and Insulin Aspart Versus Standard Therapy for the Inpatient Management of Type 2 Diabetes: the IDA2 Study
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Difference in mean daily plasma glucose between the two groups
研究概览
简要总结
Hyperglycemia during admission is associated with increased rate of complications and longer hospital stays, thus insulin treatment is recommended for all diabetes patients with hyperglycemia. Inpatient studies of non-critically ill patients show better glycemic control with the use of basal-bolus insulin therapy compared to sliding scale insulin therapy, but increased rates of hypoglycemia. The investigators hypothesize that basal-bolus insulin therapy with a new ultra-long-action basal insulin can treat hyperglycemia more efficiently than sliding scale insulin, with few episodes of hypoglycemia.
详细描述
The aim of this study is to investigate and compare the efficacy and safety of basal-bolus insulin therapy using the insulin analogue, insulin degludec once daily and insulin aspart before meals versus standard therapy with sliding scale insulin in non-critical ill hospitalized patients with type 2 diabetes.
The design of the trial is an open, randomized controlled trial with two parallel arms (treatment arm and control arm). Randomization is 1:1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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
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 (>40 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
研究组 & 干预措施
Intervention
Basal-bolus insulin regime with Insulin Degludec and insulin aspart
干预措施: Insulin Degludec 100 UNT/ML [Tresiba] (Drug)
结局指标
主要结局
Difference in mean daily plasma glucose between the two groups
时间窗: Duration of hospital stay, an expected average of 8 days
Difference in mean daily plasma glucose between the two groups, calculated by using the four daily pre-meal and bedside PG values per patient.
次要结局
- Mean number and rates of hypoglycemic events (PG ≤ 3.9 mmol/L)(Duration of hospital stay, an expected average of 8 days)
- Time spent in glycemic range(Duration of hospital stay, an expected average of 8 days)
- Time spent in hyperglycemic range(Duration of hospital stay, an expected average of 8 days)
- Length of hospital stay(Duration of hospital stay, an expected average of 8 days)
- Difference in insulin dose between groups(Duration of hospital stay, an expected average of 8 days)
- Number of hospital acquired infections during admission(Duration of hospital stay, an expected average of 8 days)
- Number of post-discharge infections or re-admissions 1 month after discharge(1 month)
研究者
Merete Bechmann Christensen
Principle investigator
Hvidovre University Hospital