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

Hyperglycemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00859079
• Other study ID #: TCW-GLP1-1
• Status: Completed
• Phase: Phase 4
• First received: March 7, 2009
• Last updated: March 9, 2009
• Start date: June 2006
• Est. completion date: January 2007

Study information

• Verified date: March 2009
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: January 2007
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2
• Hyperglycemia

Intervention

Drug:
• GLP-1
Patients received GLP-1 intravenously at a dose of 1.2 pmol/kg/min for at maximum 8 hours.
• Human regular insulin intravenously
Human regular insulin intravenously according to the Munich-registry.

Locations

Country	Name	City	State
Austria	Medical University of Graz, Department for Internal Medicine	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	number of hypoglycaemic episodes		0,30,60,120,150,180,210,240,270,300,330,360,390,420,450,480,510 min	Yes