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NCT Number: NCT00859079

Efficacy of GLP-1 Infusion in Comparison to an Insulin Infusion Protocol to Reach Normoglycemia 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.

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Key information

Conditions

Diabetes Mellitus Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medical University of Graz, Department for Internal Medicine

Graz, 8036, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GLP-1

Drug

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)

Human regular insulin intravenously

Drug

Human regular insulin intravenously according to the Munich-registry.

Other names: Insulin Actrapid, NovoNordisk, Denmark

Primary outcomes

  1. 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 outcomes

  1. 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

  2. number of hypoglycaemic episodes

    Time frame: 0,30,60,120,150,180,210,240,270,300,330,360,390,420,450,480,510 min

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2006
Study completion
2007
First posted
Mar 10, 2009
Registry last updated
Mar 10, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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