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

Primary Purpose

Diabetes Mellitus Type 2, Hyperglycemia

Status
Completed
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
GLP-1
Human regular insulin intravenously
Sponsored by
Medical University of Graz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus Type 2 focused on measuring diabetes mellitus type 2, GLP-1, insulin infusion

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Medical University of Graz, Department for Internal Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

GLP-1

Insulin intravenously

Arm Description

Intravenously administered GLP-1

Insulin intravenously according to the Munich registry

Outcomes

Primary Outcome Measures

time to reach a plasma glucose below 115 mg/dl

Secondary Outcome Measures

plasma glucose after 2 and 4 hours as well as maximum glycemia
number of hypoglycaemic episodes

Full Information

First Posted
March 7, 2009
Last Updated
March 9, 2009
Sponsor
Medical University of Graz
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1. Study Identification

Unique Protocol Identification Number
NCT00859079
Brief Title
Efficacy of GLP-1 Infusion in Comparison to an Insulin Infusion Protocol to Reach Normoglycemia Type 2 Diabetic Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
January 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Medical University of Graz

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus Type 2, Hyperglycemia
Keywords
diabetes mellitus type 2, GLP-1, insulin infusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GLP-1
Arm Type
Active Comparator
Arm Description
Intravenously administered GLP-1
Arm Title
Insulin intravenously
Arm Type
Active Comparator
Arm Description
Insulin intravenously according to the Munich registry
Intervention Type
Drug
Intervention Name(s)
GLP-1
Other Intervention Name(s)
GLP-1 infusion (CLINALFA, Laeufelingen, Switzerland)
Intervention Description
Patients received GLP-1 intravenously at a dose of 1.2 pmol/kg/min for at maximum 8 hours.
Intervention Type
Drug
Intervention Name(s)
Human regular insulin intravenously
Other Intervention Name(s)
Insulin Actrapid, NovoNordisk, Denmark
Intervention Description
Human regular insulin intravenously according to the Munich-registry.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
number of hypoglycaemic episodes
Time Frame
0,30,60,120,150,180,210,240,270,300,330,360,390,420,450,480,510 min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas C Wascher, MD
Organizational Affiliation
Medical University of Graz, Dept. of Internal Medicine, Auenbruggerpl. 15, 8036 Graz, Austria
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Graz, Department for Internal Medicine
City
Graz
ZIP/Postal Code
8036
Country
Austria

12. IPD Sharing Statement

Learn more about this trial

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

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