Efficacy of a Continuous GLP-1 Infusion in Comparison to a Structured Insulin Infusion Protocol to Reach Normoglycemia in Non-Fasted Type 2 Diabetic Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- time to reach a plasma glucose below 115 mg/dl
研究概览
简要总结
The aim of the investigators study was to compare for the first time efficacy and safety of intravenously administered GLP-1 with an established intravenous insulin regimen in hyperglycaemic type 2 diabetic patients.
详细描述
Intervention studies in patients with acute myocardial infraction or cardiac surgery, using intravenously administered human insulin, suggest that normalization of hyperglycemia can reduce morbidity as well as mortality in these patients. Insulin-based regimens require frequent blood glucose measurements and adjustments of infusion rate to achieve normoglycemia.
In addition, hypoglycaemia is a frequent and important side effect. Glucagon-Like-Peptide 1 (GLP-1) is an insulinotropic, glucagonostatic gastrointestinal hormone that lowers glucose in a glycemia-dependent manner and therefore does not cause hypoglycemia.
The aim of our study was to compare for the first time efficacy and safety of intravenously administered GLP-1 with an established intravenous insulin regimen in hyperglycaemic type 2 diabetic patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes mellitus
- •Fasting glycemia above 150 mg/dl
- •Signed informed consent
排除标准
- •Patients with heart failure > NYHA II
- •Uncontrolled hypertension
- •Impaired kidney function (creatinine > 3 mg/dl)
- •Acute infection
研究组 & 干预措施
Insulin intravenously
Insulin intravenously according to the Munich registry
干预措施: Human regular insulin intravenously (Drug)
GLP-1
Intravenously administered GLP-1
干预措施: GLP-1 (Drug)
结局指标
主要结局
time to reach a plasma glucose below 115 mg/dl
时间窗: 0,30,60,120,150,180,210,240,270,300,330,360,390,420,450,480,510 min
次要结局
- plasma glucose after 2 and 4 hours as well as maximum glycemia(0,30,60,120,150,180,210,240,270,300,330,360,390,420,450,480,510 min)
- number of hypoglycaemic episodes(0,30,60,120,150,180,210,240,270,300,330,360,390,420,450,480,510 min)