Efficacy of GLP-1 Infusion in Comparison to an Insulin Infusion Protocol to Reach Normoglycemia Type 2 Diabetic Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Diabetes Mellitus Type 2, Hyperglycemia

Intervention / Treatment
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* Drug: GLP-1
* Drug: Human regular insulin intravenously


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: GLP-1<br>Intravenously administered GLP-1 | Drug: GLP-1<br>* Patients received GLP-1 intravenously at a dose of 1.2 pmol/kg/min for at maximum 8 hours.<br>* Other names: GLP-1 infusion (CLINALFA, Laeufelingen, Switzerland);|
| Active Comparator: Insulin intravenously<br>Insulin intravenously according to the Munich registry | Drug: Human regular insulin intravenously<br>* Human regular insulin intravenously according to the Munich-registry.<br>* Other names: Insulin Actrapid, NovoNordisk, Denmark;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes mellitus type 2, GLP-1, insulin infusion