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

March 9, 2009 updated by: Medical University of Graz

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

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.

Study Overview

Status

Completed

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

Interventional

Enrollment (Actual)

8

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8036
        • Medical University of Graz, Department for Internal Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Drug: GLP-1
Patients received GLP-1 intravenously at a dose of 1.2 pmol/kg/min for at maximum 8 hours.
Other Names:
  • GLP-1 infusion (CLINALFA, Laeufelingen, Switzerland)
Active Comparator: Insulin intravenously
Insulin intravenously according to the Munich registry
Drug: Human regular insulin intravenously
Human regular insulin intravenously according to the Munich-registry.
Other Names:
  • Insulin Actrapid, NovoNordisk, Denmark

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

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Graz

Investigators

  • Principal Investigator: Thomas C Wascher, MD, Medical University of Graz, Dept. of Internal Medicine, Auenbruggerpl. 15, 8036 Graz, Austria

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

March 7, 2009

First Submitted That Met QC Criteria

March 9, 2009

First Posted (Estimate)

March 10, 2009

Study Record Updates

Last Update Posted (Estimate)

March 10, 2009

Last Update Submitted That Met QC Criteria

March 9, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TCW-GLP1-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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