NPH and Regular Insulin in the Treatment of Inpatient Hyperglycemia: Comparison of 3 Basal-bolus Regimens
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 主要终点
- Glycemic control
研究概览
简要总结
The objective of this study is to compare the therapeutic efficacy of three regimens of insulin NPH/fast for optimal glycemic control in non-critical hospitalized patients.
详细描述
Patients will be randomly assigned to one of the three treatment regimens. Also, the use of oral antidiabetic drugs would be suspended during their stay at the hospital.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admitted to medical services
- •Persistent blood glucose level > 140 mg/dL
- •With an expected stay ≥ 48 hours
排除标准
- •Subjects with type 1 diabetes mellitus
- •Parenteral nutrition
- •Glucose levels ≥ 400 mg/dL at screening
- •Diabetic ketoacidosis or non-ketosis hyperosmolar state
- •Clinically relevant hepatic disease
- •Glomerular filtration rate ≤ 30 ml/min
- •Pregnancy
- •Terminal disease
- •Inability to provide informed consent
研究组 & 干预措施
Once-daily insulin
60% of total dose of insulin as NPH insulin in the once-daily regimen was administered subcutaneously before breakfast. Also, 40% in rapid insulin before meals (every 8 hours).
干预措施: Once-daily Insulin (Drug)
Twice-daily insulin
60% of total dose of insulin as NPH insulin in the twice-daily regimen it was given before breakfast and before dinner. Also, 40% in rapid insulin before meals (every 8 hours).
干预措施: Twice-daily Insulin (Drug)
Triple-daily insulin
60% of total dose of insulin as NPH insulin in the triple daily regimen it was administered before each meal. Also, 40% in rapid insulin before meals (every 8 hours).
干预措施: Triple-daily Insulin (Drug)
结局指标
主要结局
Glycemic control
时间窗: Within the time the patient stays at hospital (2 to 14 days)
The achievement of fasting glucose between 70-140 mg/dL and random glucose levels of \<180 mg/dL
次要结局
- Differences in the percentage of glucoses in the hypoglycemic range(Within the time the patient stays at hospital (2 to 14 days))
- Total insulin dose required during follow up and at discharge to achieve glycemic control(Within the time the patient stays at hospital (2 to 14 days))
- Differences in hospital stay days(Within the time the patient stays at hospital (2 to 14 days))
研究者
Dr. med. Hector Eloy Tamez Perez
Dr. med. Hector Eloy Tamez Perez
Hospital Universitario Dr. Jose E. Gonzalez