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
1 other identifier
interventional
8
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 diabetes-mellitus-type-2
Started Jun 2006
Shorter than P25 for phase_4 diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 7, 2009
CompletedFirst Posted
Study publicly available on registry
March 10, 2009
CompletedMarch 10, 2009
March 1, 2009
6 months
March 7, 2009
March 9, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
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
Study Arms (2)
GLP-1
ACTIVE COMPARATORIntravenously administered GLP-1
Insulin intravenously
ACTIVE COMPARATORInsulin intravenously according to the Munich registry
Interventions
Patients received GLP-1 intravenously at a dose of 1.2 pmol/kg/min for at maximum 8 hours.
Human regular insulin intravenously according to the Munich-registry.
Eligibility Criteria
You may qualify if:
- Type 2 diabetes mellitus
- Fasting glycemia above 150 mg/dl
- Signed informed consent
You may not qualify if:
- Patients with heart failure \> NYHA II
- Uncontrolled hypertension
- Impaired kidney function (creatinine \> 3 mg/dl)
- Acute infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of Graz, Department for Internal Medicine
Graz, 8036, Austria
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas C Wascher, MD
Medical University of Graz, Dept. of Internal Medicine, Auenbruggerpl. 15, 8036 Graz, Austria
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 7, 2009
First Posted
March 10, 2009
Study Start
June 1, 2006
Primary Completion
December 1, 2006
Study Completion
January 1, 2007
Last Updated
March 10, 2009
Record last verified: 2009-03