The Efficacy of GLP - 1(7-36) Amide for Glycemic Control in Critically Ill Patients - Full Text View

Sponsors and Collaborators:	Johns Hopkins University Society of Critical Care Medicine
Information provided by:	Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT00798590

Purpose

The goal of this present proposal is to examine the efficacy of GLP-1 administered to control blood glucose in critically ill patients.

Condition	Intervention	Phase
Critically Ill Hypoglycemia	Drug: Glucagon-Like Peptide-1 Drug: Saline	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	The Efficacy of GLP - 1 (7-36) Amide for Glycemic Control in Critically Ill Surgical Patients

Resource links provided by NLM:

MedlinePlus related topics: Hypoglycemia

Drug Information available for: Glucagon Glucagon-like peptide 1

U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:

To compare the composite overall amount of insulin used with GLP-1 vs. placebo to reach and maintain the ICU-specific target glucose range. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Compare the # of hypoglycemic events between GLP-1/placebo treatment;Amount of meds in the control of homeostasis;Death in the ICU/in-hospital;Time of ICU stay/hospitalization;ICU infection rate;Time of ventilator support to time of extubation. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	180
Study Start Date:	December 2008
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
GLP-1: Experimental	Drug: Glucagon-Like Peptide-1 5ng/kg-1/min-1 GLP-1 infused in 3 ml continuously over 72 hours.
Saline: Placebo Comparator	Drug: Saline 5ng/kg-1/min-1 placebo infused in 3 ml continuously over 72 hours.

Detailed Description:

All patients whom on admission to the ICU (surgical, burn, & cardiac) who are expected to receive intensive insulin therapy for at least 72 hours are eligible to be enrolled. Once enrolled, the patients will be randomized to one of two groups: the experimental (intravenous GLP-1 infusion for 72 hours) or control groups (intravenous 0.9% NaCl infusion for 72 hours) in a double masked fashion. While enrolled, all patients will receive standard-of-care insulin therapy. Both groups will be maintained on the standard ICU specific protocol for glucose control.

Eligibility

Ages Eligible for Study:	21 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Men and women age > 21 to 75 years of age.
All subjects who meet ICU specific criteria for inclusion in their glucose protocol and placed on insulin infusion protocol as standard of care.
Able to obtain patient or proxy consent.

Exclusion Criteria:

Current diagnosis of malignancy.
Type 1 diabetes.
Inability to obtain informed consent.
On any Phase 1 trial.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00798590

Locations

United States, Maryland
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224

Sponsors and Collaborators

Johns Hopkins University

Society of Critical Care Medicine

Investigators

Principal Investigator:

Dariush Elahi, PhD

Johns Hopkins University

More Information

No publications provided

Responsible Party:	Johns Hopkins University School of Medicine ( Dariush Elahi )
Study ID Numbers:	NA_00022551
Study First Received:	November 25, 2008
Last Updated:	March 24, 2009
ClinicalTrials.gov Identifier:	NCT00798590 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Johns Hopkins University:

Intensive insulin therapy (IIT)
Insulin infusion
Tight glycemic control
Intensive Care Units

Study placed in the following topic categories:

Metabolic Diseases
Critical Illness
Hormone Antagonists
Glucagon
Hormones, Hormone Substitutes, and Hormone Antagonists
Incretins

Glucose Metabolism Disorders
Hypoglycemia
Hormones
Metabolic Disorder
Insulin
Glucagon-Like Peptide 1

Additional relevant MeSH terms:

Disease Attributes
Metabolic Diseases
Pathologic Processes
Critical Illness
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists

Incretins
Glucose Metabolism Disorders
Hypoglycemia
Hormones
Pharmacologic Actions
Glucagon-Like Peptide 1

ClinicalTrials.gov processed this record on September 10, 2009