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
Overview
- Phase
- Phase 4
- Intervention
- GLP-1
- Conditions
- Diabetes Mellitus Type 2
- Sponsor
- Medical University of Graz
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- time to reach a plasma glucose below 115 mg/dl
- Status
- Completed
- Last Updated
- 17 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Type 2 diabetes mellitus
- •Fasting glycemia above 150 mg/dl
- •Signed informed consent
Exclusion Criteria
- •Patients with heart failure \> NYHA II
- •Uncontrolled hypertension
- •Impaired kidney function (creatinine \> 3 mg/dl)
- •Acute infection
Arms & Interventions
GLP-1
Intravenously administered GLP-1
Intervention: GLP-1
Insulin intravenously
Insulin intravenously according to the Munich registry
Intervention: Human regular insulin intravenously
Outcomes
Primary Outcomes
time to reach a plasma glucose below 115 mg/dl
Time Frame: 0,30,60,120,150,180,210,240,270,300,330,360,390,420,450,480,510 min
Secondary Outcomes
- 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)