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

Medical University of Graz

Status and phase: Completed; Phase 4

Conditions: Hyperglycemia; Diabetes Mellitus Type 2

Treatments: Drug: Human regular insulin intravenously; Drug: GLP-1

Study type: Interventional

Funder types: Other

Identifiers

NCT00859079

TCW-GLP1-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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8 participants in 2 patient groups

GLP-1

Active Comparator group

Description:

Intravenously administered GLP-1

Treatment:

Drug: GLP-1

Insulin intravenously

Active Comparator group

Description:

Insulin intravenously according to the Munich registry

Treatment:

Drug: Human regular insulin intravenously