- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00859079
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
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Graz, Austria, 8036
- Medical University of Graz, Department for Internal Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: GLP-1
Intravenously administered GLP-1
|
Patients received GLP-1 intravenously at a dose of 1.2 pmol/kg/min for at maximum 8 hours.
Other Names:
|
Active Comparator: Insulin intravenously
Insulin intravenously according to the Munich registry
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Human regular insulin intravenously according to the Munich-registry.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
time to reach a plasma glucose below 115 mg/dl
Time Frame: 0,30,60,120,150,180,210,240,270,300,330,360,390,420,450,480,510 min
|
0,30,60,120,150,180,210,240,270,300,330,360,390,420,450,480,510 min
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
plasma glucose after 2 and 4 hours as well as maximum glycemia
Time Frame: 0,30,60,120,150,180,210,240,270,300,330,360,390,420,450,480,510 min
|
0,30,60,120,150,180,210,240,270,300,330,360,390,420,450,480,510 min
|
number of hypoglycaemic episodes
Time Frame: 0,30,60,120,150,180,210,240,270,300,330,360,390,420,450,480,510 min
|
0,30,60,120,150,180,210,240,270,300,330,360,390,420,450,480,510 min
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Thomas C Wascher, MD, Medical University of Graz, Dept. of Internal Medicine, Auenbruggerpl. 15, 8036 Graz, Austria
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Hyperglycemia
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Incretins
- Insulin
- Insulin, Globin Zinc
- Glucagon-Like Peptide 1
Other Study ID Numbers
- TCW-GLP1-1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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