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

NCT ID: NCT00859079

Last Updated: 2009-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2007-01-31

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.

Conditions

Diabetes Mellitus Type 2; Hyperglycemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GLP-1

Intravenously administered GLP-1

Group Type: ACTIVE_COMPARATOR

GLP-1

Intervention Type: DRUG

Patients received GLP-1 intravenously at a dose of 1.2 pmol/kg/min for at maximum 8 hours.

Insulin intravenously

Insulin intravenously according to the Munich registry

Group Type: ACTIVE_COMPARATOR

Human regular insulin intravenously

Intervention Type: DRUG

Human regular insulin intravenously according to the Munich-registry.

Interventions

GLP-1

Patients received GLP-1 intravenously at a dose of 1.2 pmol/kg/min for at maximum 8 hours.

Intervention Type: DRUG

Human regular insulin intravenously

Human regular insulin intravenously according to the Munich-registry.

Intervention Type: DRUG

Other Intervention Names

GLP-1 infusion (CLINALFA, Laeufelingen, Switzerland); Insulin Actrapid, NovoNordisk, Denmark

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Graz

OTHER

Sponsor Role: lead

Responsible Party

Medical University of Graz

Principal Investigators

Thomas C Wascher, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz, Dept. of Internal Medicine, Auenbruggerpl. 15, 8036 Graz, Austria

Locations

Medical University of Graz, Department for Internal Medicine

Graz, , Austria

Countries

Austria

Other Identifiers

TCW-GLP1-1

Identifier Type: -

Identifier Source: org_study_id