Efficacy of GLP-1 Infusion in Comparison to an Insulin Infusion Protocol to Reach Normoglycemia Type 2 Diabetic Patients
- Conditions
- Diabetes Mellitus Type 2Hyperglycemia
- Interventions
- Drug: Human regular insulin intravenously
- Registration Number
- NCT00859079
- Lead Sponsor
- Medical University of Graz
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8
- Type 2 diabetes mellitus
- Fasting glycemia above 150 mg/dl
- Signed informed consent
- Patients with heart failure > NYHA II
- Uncontrolled hypertension
- Impaired kidney function (creatinine > 3 mg/dl)
- Acute infection
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Insulin intravenously Human regular insulin intravenously Insulin intravenously according to the Munich registry GLP-1 GLP-1 Intravenously administered GLP-1
- Primary Outcome Measures
Name Time Method time to reach a plasma glucose below 115 mg/dl 0,30,60,120,150,180,210,240,270,300,330,360,390,420,450,480,510 min
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Medical University of Graz, Department for Internal Medicine
🇦🇹Graz, Austria