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The Efficacy of Glucagon Like Peptide (GLP) - 1(7-36) Amide for Glycemic Control in Critically Ill Patients

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ClinicalTrials.gov Identifier: NCT00798590
Recruitment Status : Terminated (PI left JHU)
First Posted : November 26, 2008
Results First Posted : July 2, 2017
Last Update Posted : July 2, 2017
Sponsor:
Collaborator:
Society of Critical Care Medicine
Information provided by (Responsible Party):
Johns Hopkins University

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

Condition or disease Intervention/treatment Phase
Critically Ill Hypoglycemia Drug: Glucagon-Like Peptide-1 Drug: Saline Phase 2

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% sodium chloride (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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Efficacy of GLP - 1 (7-36) Amide for Glycemic Control in Critically Ill Surgical Patients
Study Start Date : December 2008
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Glucagon
U.S. FDA Resources

Arm Intervention/treatment
Experimental: GLP-1 Drug: Glucagon-Like Peptide-1
5ng/kg-1/min-1 GLP-1 infused in 3 ml continuously over 72 hours.
Other Name: GLP-1
Placebo Comparator: Saline Drug: Saline
5ng/kg-1/min-1 placebo infused in 3 ml continuously over 72 hours.



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Compare the Number of Hypoglycemic Events Between GLP-1/Placebo Treatment [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00798590     History of Changes
Other Study ID Numbers: NA_00022551
First Posted: November 26, 2008    Key Record Dates
Results First Posted: July 2, 2017
Last Update Posted: July 2, 2017
Last Verified: June 2017

Keywords provided by Johns Hopkins University:
Intensive insulin therapy (IIT)
Insulin infusion
Tight glycemic control
Intensive Care Units

Additional relevant MeSH terms:
Critical Illness
Hypoglycemia
Disease Attributes
Pathologic Processes
Glucose Metabolism Disorders
Metabolic Diseases
Glucagon
Glucagon-Like Peptide 1
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Incretins