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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00859079

Enrollment

Registered

2009-03-10

Start date

2006-06-30

Completion date

2007-01-31

Last updated

2009-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus Type 2, Hyperglycemia

Keywords

diabetes mellitus type 2, GLP-1, insulin infusion

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.

Interventions

DRUGGLP-1

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

DRUGHuman regular insulin intravenously

Human regular insulin intravenously according to the Munich-registry.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	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

Measure	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

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026